Diabetes Mellitus, Type II, Periodontitis
Conditions
Brief summary
With poorly controlled diabetes, periodontal status often worsens, and with severe periodontal conditions there is often poorer glycemic control. There are few published reports investigating the efficacy of periodontal therapy in diabetics and fewer that include evaluation of the oral microbial profiles (the microbiome). The investigators will examine systemic changes in diabetes status and microbiome influences on clinical response to periodontal therapy in a randomized clinical trial of participants with and without diabetes and with periodontal disease. Two different treatments will be used: 1. Scaling and root planning (SRP) alone, or 2. SRP and supportive periodontal therapy (SPT), the use of chlorhexidine gluconate rinse (Paroex®) and a rubber interdental bristle cleaner (Soft-Picks) The main goal of this clinical trial is to evaluate the effects of SRP alone versus SRP+SPT on clinical, microbiological and immunological status in participants. A clearer understanding of how periodontal therapy affects diabetes status could lead to the development of new therapies for periodontal disease and diabetes.
Detailed description
With poorly controlled diabetes, periodontal disease worsens, and with severe periodontal conditions, there is often poorer glycemic control. Published papers conclude that periodontal treatment leads to a reduction in hemoglobin A1c; however, other studies show limited or no improvement. Some patients do not respond well to professional periodontal therapy, even without diabetes, which could be related to poor oral hygiene and/or host factors including microbial profiles. There are few published papers investigating the efficacy of periodontal therapy in diabetics and fewer that include assessment of the oral microbiome. The investigators will examine systemic changes in diabetes status and microbiome influences on clinical response to periodontal therapy in a randomized clinical trial. It has been shown that chlorhexidine gluconate rinse leads to significant clinical improvement over standard periodontal therapy alone, and interdental tooth cleaners remove more dental plaque (leading to reduced gingival inflammation) effectively than brushing alone. Therefore, in this study, standard periodontal therapy, scaling and root planning (SRP) will be provided alone, or SRP plus supportive periodontal therapy (SPT), the use of chlorhexidine gluconate rinse (Paroex®) and a rubber interdental bristle cleaner (Soft-Picks), to diabetics and non-diabetics with periodontal disease to determine the differences in response between the groups. The main aim of this study is to evaluate the effects of SRP alone versus SRP+SPT on clinical, microbiological and immunological status of subjects with and without type 2 diabetes and with periodontal disease. A clearer understanding of how periodontal therapy affects diabetes status could lead to the development of novel new targeted therapies of both periodontal disease and diabetes.
Interventions
Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
PROCEDUREScaling & Root Planing
SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
DEVICESoft Picks
Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
Sponsors
Sunstar, Inc.
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be able to understand the informed consent form and be willing and able to read and sign it. 2. At least 25 years of age. 3. Be able to understand and follow directions for study procedures. 4. At least 14 natural teeth, not counting third molars (wisdom teeth). 5. At least 2 interproximal sites with CAL \>= 4 mm or at least 2 interproximal sites with PD \>= 5 mm.
Exclusion criteria
1. Presence of orthodontic appliances (braces). 2. An abnormal condition of lips, lining of the mouth, tongue, or gums (except for periodontal disease). If subject has a cold sore, canker sore, or injury in their mouth, they may return after the sore or injury heals. 3. Abscess of the gingiva caused by periodontal disease, or visible gross tooth decay 4. A broken tooth root or an abscessed tooth. Subject may be allowed to participate in the study after the condition is successfully treated. 5. Periodontal treatment or antibiotic therapy in the past 6 months. 6. Have used cigarettes or other tobacco products in the past year. 7. Body mass index (BMI) is \> 40. 8. Have regularly used non-steroidal anti-inflammatory drugs (such as \>= 325 mg aspirin or ibuprofen) over the past 3 weeks. 9. Regularly using drugs that weaken the immune system (such as corticosteroids taken by mouth or injection, and cyclosporine). 10. Have participated in another clinical research study in the past 30 days. 11. Pregnant or breastfeeding. 12. Have a condition that we feel will make study participation unsafe or difficult for the patient. 13. Require premedication for dental exams.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline | Baseline to 6 months | Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; site status is compared between timepoints measured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline | Baseline to 3 months;Baseline to 6 months | The distance from the Cemento-enamel Junction (CEJ) to the free gingival margin is measured with a periodontal probe. Millimeters of recession (loss of attachment) is recorded as a negative number; when the gingival margin is above the CEJ, the measurement (in millimeters) is recorded as positive. |
| Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline | Baseline to 3 months; Baseline to 6 months | The analysis is based on the measures of each participant. Participant instead of site is used as unite for arm/group. The measure, % sites with probing pocket depth \>= 4 mm within each participant, indicates the portion of deep pocket in a participant. Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; The percentage of sites with Periodontal PD \>= 4 mm within each participant was compared between measured time points. |
| Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline | Baseline to 3 months; Baseline to 6 months | The analysis is based on the measures of each participant. 0 is the absence of gingival bleeding and 1 is the presence of gingival bleeding after probing and measuring for pocket depth. Bleeding on probing index is defined as the percentage of sites with presence of gingival bleeding after probing per participant. The value of bleeding on probing index ranges from 0 to 100 for each participant. The bleeding on probing index per participant is compared between time points measured. |
| Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline | Baseline to 3 months; Baseline to 6 months | The analysis is based on the measures of each participant. Plaque is visually measured on 6 sites per tooth; 0 is the absence of any plaque. 1 is the presence of plaque. For each participant, 6 sites per tooth are evaluated. The Plaque Index (PI) of each participant is defined as the percentage of sites with plaque. The value of PI ranges from 0 to 100 for each participant. The PI of each participant is assessed and compared between measured time points. |
| Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics | Baseline to 3 months; Baseline to 6 months | Probing depth (PD) or probing pocket depth (PPD), measured on six surfaces/tooth, is the distance in millimeters (mm) from the gingival margin to the base of the gingival pocket |
| Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 3 months; Baseline to 6 months | The distance from the Cemento-enamel Junction (CEJ) to the free gingival margin is measured with a periodontal probe. Millimeters of recession (loss of attachment) is recorded as a negative number; when the gingival margin is above the CEJ, the measurement (in millimeters) is recorded as positive. |
| Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline in Diabetics and Non-diabetics | Baseline to 3 months; Baseline to 6 months | The analysis is based on the measure of each participant. Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; The percentage of sites with Periodontal PD \>= 4 mm per participant is compared between measured time points. |
| Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 3 months; Baseline to 6 months | The analysis is based on the measures of each participant. 0 is the absence of gingival bleeding and 1 is the presence of gingival bleeding after probing and measuring for pocket depth. Bleeding on probing index is defined as the percentage of sites with presence of gingival bleeding after probing per participant. The value of bleeding on probing index ranges from 0 to 100 for each participant. The bleeding on probing index per participant is compared between time points measured. |
| Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline | Baseline to 3 months | Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; site status is compared between timepoints measured |
| Changes in Hemoglobin A1c at 6 Months After Treatment | Baseline to 6 months | Hemoglobin in A1c (HbA1c) tells the average level of blood sugar over the prior 2 to 3 months. Normal level is below 5.7%; 5.7%-6.4% indicates prediabetes; greater than 6.5% is indicative of diabetes. |
| Changes in Fasting Blood Glucose at 6 Months After Treatment | Baseline to 6 months | Fasting blood sugar/glucose (FBS/FBG) is tested with a blood sample taken after an overnight fast. A fasting blood sugar level less than 100 mg/dL is normal; a fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes; a level 126 mg/dL (7 mmol/L) or higher on two separate tests, indicates diabetes. |
| Change in High Sensitivity C-reactive Protein at 6 Months After Treatment | Baseline to 6 months | The high-sensitivity C-reactive protein (hs-CRP) blood test measures body inflammation indicating infection or a chronic inflammatory disease such as periodontitis or diabetes. It also can be used to evaluate risk of developing coronary artery disease. A normal reading is less than 10 milligram per liter (mg/L); a level greater than 10 mg/L is a sign of serious infection, trauma or chronic disease likely requiring further testing to determine cause |
| Changes in Hemoglobin A1c at 6 Months After Treatment in Diabetics and Non-diabetics | Baseline to 6 months | Hemoglobin in A1c (HbA1c) tells the average level of blood sugar over the prior 2 to 3 months. Normal level is below 5.7%; 5.7%-6.4% indicates prediabetes; greater than 6.5% is indicative of diabetes. |
| Changes in Fasting Blood Glucose at 6 Months After Treatment in Diabetics and Non-diabetics | Baseline to 6 months | Fasting blood sugar/glucose (FBS/FBG) is tested with a blood sample taken after an overnight fast. A fasting blood sugar level less than 100 mg/dL is normal; a fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes; a level 126 mg/dL (7 mmol/L) or higher on two separate tests, indicates diabetes. |
| Change in High Sensitivity C-reactive Protein at 6 Months After Treatment in Diabetics and Non-diabetics | Baseline to 6 months | The high-sensitivity C-reactive protein (hs-CRP) blood test measures body inflammation indicating infection or a chronic inflammatory disease such as periodontitis or diabetes. It also can be used to evaluate risk of developing coronary artery disease. A normal reading is less than 10 milligram per liter (mg/L); a level greater than 10 mg/L is a sign of serious infection, trauma or chronic disease likely requiring further testing to determine cause |
| Shannon Index of the Subgingival Plaque Microbiome at Baseline and 6 Months | Baseline; 6 Months | Shannon index represents mean species diversity in a site at a local scale. Shannon index quantifies the uncertainty in predicting the species identity of an individual that is taken at random from the dataset. The minimum value is 0 and there is no maximum value. High values mean high species diversities. |
| Change in Distance to the Healthy Plane Based on the Subgingival Plaque Microbiome at 6 Months | Baseline to 6 Months | Analysis of microbiome community changes using the healthy plane (HP) as a reference. A healthy plane was calculated by fitting a plane that minimizes the sum of squares of distances from HC samples to the nearest point on the plane. The distance of each sample to the HP was then calculated. Higher values of distance to HP mean microbiome community changes towards disease status |
| Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 3 months; Baseline to 6 months | The analysis is based on the measures of each participant. Plaque is visually measured on 6 sites per tooth; 0 is the absence of any plaque. 1 is the presence of plaque. For each participant, 6 sites per tooth are evaluated. The Plaque Index (PI) of each participant is defined as the percentage of sites with plaque. The value of PI ranges from 0 to 100 for each participant. The PI of each participant is assessed and compared between measured time points. |
Countries
United States
Participant flow
Pre-assignment details
Of 116 enrolled participants, 114 met inclusion criteria and were randomized for treatment
Participants by arm
| Arm | Count |
|---|---|
| Diabetic + SRP + SPT The group includes diabetics with periodontal disease; they will receive standard therapy, scaling & root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling & Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores. | 21 |
| Diabetic + SRP The group includes diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling & Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums. | 23 |
| Non-Diabetic + SRP + SPT The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling & root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling & Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores. | 24 |
| Non-Diabetic + SRP The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling & Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums. | 18 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 4 |
| Overall Study | Protocol Violation | 3 | 9 |
| Overall Study | Withdrawal by Subject | 6 | 2 |
Baseline characteristics
| Characteristic | Diabetic + SRP + SPT | Diabetic + SRP | Non-Diabetic + SRP + SPT | Non-Diabetic + SRP | Total |
|---|---|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 8.8 | 66 years STANDARD_DEVIATION 8.7 | 65.5 years STANDARD_DEVIATION 10.9 | 62.3 years STANDARD_DEVIATION 7.3 | 63.8 years STANDARD_DEVIATION 9.2 |
| Alcohol Intake Current | 13 Participants | 11 Participants | 17 Participants | 14 Participants | 55 Participants |
| Alcohol Intake Former | 7 Participants | 8 Participants | 4 Participants | 3 Participants | 22 Participants |
| Alcohol Intake Never | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Alcohol Intake Unknown | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 5 Participants |
| Bleeding on Probing (BOP) Index per participant | 40 BOP index of a participant STANDARD_DEVIATION 17.2 | 35.9 BOP index of a participant STANDARD_DEVIATION 13.4 | 34.9 BOP index of a participant STANDARD_DEVIATION 11.9 | 35.3 BOP index of a participant STANDARD_DEVIATION 15.3 | 36.5 BOP index of a participant STANDARD_DEVIATION 14.3 |
| BMI | 32.5 kg/m^2 STANDARD_DEVIATION 5.1 | 32.5 kg/m^2 STANDARD_DEVIATION 6.8 | 29.6 kg/m^2 STANDARD_DEVIATION 5.6 | 27.7 kg/m^2 STANDARD_DEVIATION 4.9 | 30.7 kg/m^2 STANDARD_DEVIATION 5.9 |
| C-reactive Protein (CRP) | 2.5 mg/L | 1.8 mg/L | 2.2 mg/L | 1.2 mg/L | 1.9 mg/L |
| Education | 15.6 year STANDARD_DEVIATION 2.4 | 16.1 year STANDARD_DEVIATION 2.1 | 15.1 year STANDARD_DEVIATION 2.3 | 13.8 year STANDARD_DEVIATION 1.8 | 15.2 year STANDARD_DEVIATION 2.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 23 Participants | 24 Participants | 18 Participants | 86 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fasting Blood Glucose | 129 mg/dL | 135 mg/dL | 92 mg/dL | 90 mg/dL | 107 mg/dL |
| Hemoglobin A1c | 7 % of hemoglobin a1c | 7 % of hemoglobin a1c | 5.5 % of hemoglobin a1c | 5.2 % of hemoglobin a1c | 6 % of hemoglobin a1c |
| Plaque Index (PI) per participant | 48.0 Plaque Index of a participant STANDARD_DEVIATION 16.7 | 47.1 Plaque Index of a participant STANDARD_DEVIATION 13.7 | 38.9 Plaque Index of a participant STANDARD_DEVIATION 11.5 | 40.3 Plaque Index of a participant STANDARD_DEVIATION 14.6 | 43.6 Plaque Index of a participant STANDARD_DEVIATION 14.5 |
| Race/Ethnicity, Customized African American | 5 Participants | 1 Participants | 1 Participants | 1 Participants | 8 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 15 Participants | 22 Participants | 22 Participants | 17 Participants | 76 Participants |
| Sex: Female, Male Female | 3 Participants | 8 Participants | 12 Participants | 9 Participants | 32 Participants |
| Sex: Female, Male Male | 18 Participants | 15 Participants | 12 Participants | 9 Participants | 54 Participants |
| % sites with Pocket Depth ≥ 4 mm per participant | 24.9 % sites with PD >= 4 mm of a participant STANDARD_DEVIATION 15.8 | 18.7 % sites with PD >= 4 mm of a participant STANDARD_DEVIATION 7.2 | 21.4 % sites with PD >= 4 mm of a participant STANDARD_DEVIATION 10.6 | 20.2 % sites with PD >= 4 mm of a participant STANDARD_DEVIATION 10.6 | 21.3 % sites with PD >= 4 mm of a participant STANDARD_DEVIATION 11.4 |
| Smoking History Former | 11 Participants | 7 Participants | 11 Participants | 8 Participants | 37 Participants |
| Smoking History Never Smoked | 9 Participants | 15 Participants | 13 Participants | 10 Participants | 47 Participants |
| Smoking History Unknown | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Whole Mouth Mean Clinical Attachment Loss | 3.5 mm STANDARD_DEVIATION 0.8 | 3.2 mm STANDARD_DEVIATION 0.7 | 3.3 mm STANDARD_DEVIATION 0.7 | 3.3 mm STANDARD_DEVIATION 0.5 | 3.3 mm STANDARD_DEVIATION 0.7 |
| Whole Mouth Mean Pocket Depth | 3 mm STANDARD_DEVIATION 0.5 | 2.7 mm STANDARD_DEVIATION 0.2 | 2.9 mm STANDARD_DEVIATION 0.4 | 2.8 mm STANDARD_DEVIATION 0.3 | 2.8 mm STANDARD_DEVIATION 0.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 23 | 0 / 24 | 0 / 18 |
| other Total, other adverse events | 0 / 21 | 0 / 23 | 0 / 24 | 0 / 18 |
| serious Total, serious adverse events | 0 / 21 | 0 / 23 | 0 / 24 | 0 / 18 |
Outcome results
Primary
Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline
Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; site status is compared between timepoints measured
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: SRP + SPT | Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline | -0.25 mm | Standard Deviation 0.24 |
| Group B: SRP | Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline | -0.18 mm | Standard Deviation 0.2 |
p-value: 0.16t-test, 2 sided
Secondary
Change in Distance to the Healthy Plane Based on the Subgingival Plaque Microbiome at 6 Months
Analysis of microbiome community changes using the healthy plane (HP) as a reference. A healthy plane was calculated by fitting a plane that minimizes the sum of squares of distances from HC samples to the nearest point on the plane. The distance of each sample to the HP was then calculated. Higher values of distance to HP mean microbiome community changes towards disease status
Time frame: Baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: SRP + SPT | Change in Distance to the Healthy Plane Based on the Subgingival Plaque Microbiome at 6 Months | -2.16 distance to the healthy plane | Standard Deviation 5.84 |
| Group B: SRP | Change in Distance to the Healthy Plane Based on the Subgingival Plaque Microbiome at 6 Months | -1.26 distance to the healthy plane | Standard Deviation 7.37 |
p-value: 0.53t-test, 2 sided
Secondary
Change in High Sensitivity C-reactive Protein at 6 Months After Treatment
The high-sensitivity C-reactive protein (hs-CRP) blood test measures body inflammation indicating infection or a chronic inflammatory disease such as periodontitis or diabetes. It also can be used to evaluate risk of developing coronary artery disease. A normal reading is less than 10 milligram per liter (mg/L); a level greater than 10 mg/L is a sign of serious infection, trauma or chronic disease likely requiring further testing to determine cause
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: SRP + SPT | Change in High Sensitivity C-reactive Protein at 6 Months After Treatment | -0.33 mg/L | Standard Deviation 4.31 |
| Group B: SRP | Change in High Sensitivity C-reactive Protein at 6 Months After Treatment | -1.25 mg/L | Standard Deviation 8.84 |
p-value: 0.12t-test, 2 sided
Secondary
Change in High Sensitivity C-reactive Protein at 6 Months After Treatment in Diabetics and Non-diabetics
The high-sensitivity C-reactive protein (hs-CRP) blood test measures body inflammation indicating infection or a chronic inflammatory disease such as periodontitis or diabetes. It also can be used to evaluate risk of developing coronary artery disease. A normal reading is less than 10 milligram per liter (mg/L); a level greater than 10 mg/L is a sign of serious infection, trauma or chronic disease likely requiring further testing to determine cause
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: SRP + SPT | Change in High Sensitivity C-reactive Protein at 6 Months After Treatment in Diabetics and Non-diabetics | 0.23 mg/L | Standard Deviation 2.11 |
| Group B: SRP | Change in High Sensitivity C-reactive Protein at 6 Months After Treatment in Diabetics and Non-diabetics | -2.23 mg/L | Standard Deviation 11.82 |
| Non-Diabetic + SRP + SPT | Change in High Sensitivity C-reactive Protein at 6 Months After Treatment in Diabetics and Non-diabetics | -0.41 mg/L | Standard Deviation 5.57 |
| Non-Diabetic + SRP | Change in High Sensitivity C-reactive Protein at 6 Months After Treatment in Diabetics and Non-diabetics | 0.01 mg/L | Standard Deviation 0.56 |
p-value: 0.46t-test, 2 sided
p-value: 0.11t-test, 2 sided
Secondary
Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline
The analysis is based on the measures of each participant. Plaque is visually measured on 6 sites per tooth; 0 is the absence of any plaque. 1 is the presence of plaque. For each participant, 6 sites per tooth are evaluated. The Plaque Index (PI) of each participant is defined as the percentage of sites with plaque. The value of PI ranges from 0 to 100 for each participant. The PI of each participant is assessed and compared between measured time points.
Time frame: Baseline to 3 months; Baseline to 6 months
Population: For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: SRP + SPT | Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline | Baseline to 3 months | -14.76 Plaque Index of a participant | Standard Deviation 11.52 |
| Group A: SRP + SPT | Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline | Baseline to 6 months | 9.68 Plaque Index of a participant | Standard Deviation 12.22 |
| Group B: SRP | Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline | Baseline to 3 months | -7.7 Plaque Index of a participant | Standard Deviation 12.5 |
| Group B: SRP | Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline | Baseline to 6 months | -5.19 Plaque Index of a participant | Standard Deviation 12.08 |
Comparison: Baseline to 3 monthsp-value: <0.01t-test, 2 sided
Comparison: Baseline to 6 monthsp-value: 0.09t-test, 2 sided
Secondary
Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
The analysis is based on the measures of each participant. Plaque is visually measured on 6 sites per tooth; 0 is the absence of any plaque. 1 is the presence of plaque. For each participant, 6 sites per tooth are evaluated. The Plaque Index (PI) of each participant is defined as the percentage of sites with plaque. The value of PI ranges from 0 to 100 for each participant. The PI of each participant is assessed and compared between measured time points.
Time frame: Baseline to 3 months; Baseline to 6 months
Population: For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: SRP + SPT | Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 3 months | -17.46 Plaque Index of a participant | Standard Deviation 13.19 |
| Group A: SRP + SPT | Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 6 months | -12.11 Plaque Index of a participant | Standard Deviation 14.05 |
| Group B: SRP | Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 6 months | -4.97 Plaque Index of a participant | Standard Deviation 12.43 |
| Group B: SRP | Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 3 months | -7.67 Plaque Index of a participant | Standard Deviation 13.16 |
| Non-Diabetic + SRP + SPT | Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 3 months | -12.4 Plaque Index of a participant | Standard Deviation 9.48 |
| Non-Diabetic + SRP + SPT | Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 6 months | -7.56 Plaque Index of a participant | Standard Deviation 10.18 |
| Non-Diabetic + SRP | Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 3 months | -7.75 Plaque Index of a participant | Standard Deviation 11.99 |
| Non-Diabetic + SRP | Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 6 months | -5.48 Plaque Index of a participant | Standard Deviation 11.96 |
Comparison: Baseline to 3 monthsp-value: 0.02t-test, 2 sided
Comparison: Baseline to 3 monthsp-value: 0.18t-test, 2 sided
Comparison: Baseline to 6 monthsp-value: 0.08t-test, 2 sided
Comparison: Baseline to 6 monthsp-value: 0.41t-test, 2 sided
Secondary
Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics
Probing depth (PD) or probing pocket depth (PPD), measured on six surfaces/tooth, is the distance in millimeters (mm) from the gingival margin to the base of the gingival pocket
Time frame: Baseline to 3 months; Baseline to 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: SRP + SPT | Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics | Baseline to 3-month | -0.36 mm | Standard Deviation 0.29 |
| Group A: SRP + SPT | Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics | Baseline to 6-month | -0.27 mm | Standard Deviation 0.27 |
| Group B: SRP | Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics | Baseline to 6-month | -0.12 mm | Standard Deviation 0.19 |
| Group B: SRP | Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics | Baseline to 3-month | -0.17 mm | Standard Deviation 0.17 |
| Non-Diabetic + SRP + SPT | Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics | Baseline to 3-month | -0.26 mm | Standard Deviation 0.24 |
| Non-Diabetic + SRP + SPT | Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics | Baseline to 6-month | -0.24 mm | Standard Deviation 0.21 |
| Non-Diabetic + SRP | Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics | Baseline to 3-month | -0.27 mm | Standard Deviation 0.26 |
| Non-Diabetic + SRP | Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics | Baseline to 6-month | -0.26 mm | Standard Deviation 0.19 |
Comparison: Baseline to 3 monthsp-value: 0.01t-test, 2 sided
Comparison: Baseline to 3 monthsp-value: 0.86t-test, 2 sided
Comparison: Baseline to 6 monthsp-value: 0.047t-test, 2 sided
Comparison: Baseline to 6 monthsp-value: 0.75t-test, 2 sided
Secondary
Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline
Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; site status is compared between timepoints measured
Time frame: Baseline to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: SRP + SPT | Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline | -0.31 mm | Standard Deviation 0.27 |
| Group B: SRP | Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline | -0.21 mm | Standard Deviation 0.22 |
p-value: 0.08t-test, 2 sided
Secondary
Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline
The analysis is based on the measures of each participant. Participant instead of site is used as unite for arm/group. The measure, % sites with probing pocket depth \>= 4 mm within each participant, indicates the portion of deep pocket in a participant. Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; The percentage of sites with Periodontal PD \>= 4 mm within each participant was compared between measured time points.
Time frame: Baseline to 3 months; Baseline to 6 months
Population: For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: SRP + SPT | Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline | Baseline to 3-month | -8.71 % sites with PD >= 4 mm of a participant | Standard Deviation 7.03 |
| Group A: SRP + SPT | Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline | Baseline to 6-month | -7.03 % sites with PD >= 4 mm of a participant | Standard Deviation 6.72 |
| Group B: SRP | Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline | Baseline to 3-month | -4.74 % sites with PD >= 4 mm of a participant | Standard Deviation 5.1 |
| Group B: SRP | Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline | Baseline to 6-month | -4.73 % sites with PD >= 4 mm of a participant | Standard Deviation 5.35 |
Comparison: Baseline to 3 monthsp-value: <0.01t-test, 2 sided
p-value: 0.09t-test, 2 sided
Secondary
Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline in Diabetics and Non-diabetics
The analysis is based on the measure of each participant. Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; The percentage of sites with Periodontal PD \>= 4 mm per participant is compared between measured time points.
Time frame: Baseline to 3 months; Baseline to 6 months
Population: For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: SRP + SPT | Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline in Diabetics and Non-diabetics | Baseline to 3-month | -10.23 % sites with PD >= 4 mm of a participant | Standard Deviation 7.88 |
| Group A: SRP + SPT | Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline in Diabetics and Non-diabetics | Baseline to 6-month | -7.85 % sites with PD >= 4 mm of a participant | Standard Deviation 8.02 |
| Group B: SRP | Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline in Diabetics and Non-diabetics | Baseline to 6-month | 4.12 % sites with PD >= 4 mm of a participant | Standard Deviation 5.55 |
| Group B: SRP | Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline in Diabetics and Non-diabetics | Baseline to 3-month | -4.22 % sites with PD >= 4 mm of a participant | Standard Deviation 4.22 |
| Non-Diabetic + SRP + SPT | Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline in Diabetics and Non-diabetics | Baseline to 6-month | -6.3 % sites with PD >= 4 mm of a participant | Standard Deviation 5.41 |
| Non-Diabetic + SRP + SPT | Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline in Diabetics and Non-diabetics | Baseline to 3-month | -7.39 % sites with PD >= 4 mm of a participant | Standard Deviation 6.05 |
| Non-Diabetic + SRP | Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline in Diabetics and Non-diabetics | Baseline to 3-month | -5.4 % sites with PD >= 4 mm of a participant | Standard Deviation 6.12 |
| Non-Diabetic + SRP | Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline in Diabetics and Non-diabetics | Baseline to 6-month | -5.52 % sites with PD >= 4 mm of a participant | Standard Deviation 5.13 |
Comparison: Baseline to 3 monthsp-value: <0.01t-test, 2 sided
Comparison: Baseline to 3 monthsp-value: 0.31t-test, 2 sided
Comparison: Baseline to 6 monthsp-value: 0.08t-test, 2 sided
Comparison: Baseline to 6 monthsp-value: 0.54t-test, 2 sided
Secondary
Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline
The analysis is based on the measures of each participant. 0 is the absence of gingival bleeding and 1 is the presence of gingival bleeding after probing and measuring for pocket depth. Bleeding on probing index is defined as the percentage of sites with presence of gingival bleeding after probing per participant. The value of bleeding on probing index ranges from 0 to 100 for each participant. The bleeding on probing index per participant is compared between time points measured.
Time frame: Baseline to 3 months; Baseline to 6 months
Population: For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: SRP + SPT | Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline | Baseline to 3 months | -13.24 BOP index of a participant | Standard Deviation 9.69 |
| Group A: SRP + SPT | Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline | Baseline to 6 months | -8.93 BOP index of a participant | Standard Deviation 10.76 |
| Group B: SRP | Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline | Baseline to 3 months | -5.57 BOP index of a participant | Standard Deviation 10.1 |
| Group B: SRP | Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline | Baseline to 6 months | -4.09 BOP index of a participant | Standard Deviation 9.22 |
Comparison: Baseline to 3 monthsp-value: <0.01t-test, 2 sided
Comparison: Baseline to 6 monthsp-value: 0.03t-test, 2 sided
Secondary
Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
The analysis is based on the measures of each participant. 0 is the absence of gingival bleeding and 1 is the presence of gingival bleeding after probing and measuring for pocket depth. Bleeding on probing index is defined as the percentage of sites with presence of gingival bleeding after probing per participant. The value of bleeding on probing index ranges from 0 to 100 for each participant. The bleeding on probing index per participant is compared between time points measured.
Time frame: Baseline to 3 months; Baseline to 6 months
Population: For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: SRP + SPT | Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 3 months | -13.45 BOP index of a participant | Standard Deviation 11.31 |
| Group A: SRP + SPT | Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 6 months | -9.62 BOP index of a participant | Standard Deviation 13.34 |
| Group B: SRP | Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 6 months | -1.95 BOP index of a participant | Standard Deviation 8.83 |
| Group B: SRP | Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 3 months | -4.35 BOP index of a participant | Standard Deviation 10.62 |
| Non-Diabetic + SRP + SPT | Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 3 months | -13.06 BOP index of a participant | Standard Deviation 8.27 |
| Non-Diabetic + SRP + SPT | Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 6 months | -8.32 BOP index of a participant | Standard Deviation 8.12 |
| Non-Diabetic + SRP | Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 3 months | -7.13 BOP index of a participant | Standard Deviation 9.45 |
| Non-Diabetic + SRP | Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 6 months | -6.82 BOP index of a participant | Standard Deviation 9.23 |
Comparison: Baseline to 3 monthsp-value: 0.01t-test, 2 sided
Comparison: Baseline to 3 monthsp-value: 0.04t-test, 2 sided
Comparison: Baseline to 6 monthsp-value: 0.03t-test, 2 sided
Comparison: Baseline to 6 monthsp-value: 0.38t-test, 2 sided
Secondary
Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline
The distance from the Cemento-enamel Junction (CEJ) to the free gingival margin is measured with a periodontal probe. Millimeters of recession (loss of attachment) is recorded as a negative number; when the gingival margin is above the CEJ, the measurement (in millimeters) is recorded as positive.
Time frame: Baseline to 3 months;Baseline to 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: SRP + SPT | Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline | Baseline to 3-month | -0.1 mm | Standard Deviation 0.29 |
| Group A: SRP + SPT | Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline | Baseline to 6-month | -0.1 mm | Standard Deviation 0.25 |
| Group B: SRP | Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline | Baseline to 3-month | -0.2 mm | Standard Deviation 0.29 |
| Group B: SRP | Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline | Baseline to 6-month | -0.12 mm | Standard Deviation 0.27 |
Comparison: Baseline to 3 monthsp-value: 0.14t-test, 2 sided
Comparison: Baseline to 6 monthsp-value: 0.8t-test, 2 sided
Secondary
Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
The distance from the Cemento-enamel Junction (CEJ) to the free gingival margin is measured with a periodontal probe. Millimeters of recession (loss of attachment) is recorded as a negative number; when the gingival margin is above the CEJ, the measurement (in millimeters) is recorded as positive.
Time frame: Baseline to 3 months; Baseline to 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: SRP + SPT | Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 3 months | -0.11 mm | Standard Deviation 0.28 |
| Group A: SRP + SPT | Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 6 months | -0.14 mm | Standard Deviation 0.24 |
| Group B: SRP | Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 6 months | -0.06 mm | Standard Deviation 0.24 |
| Group B: SRP | Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 3 months | -0.17 mm | Standard Deviation 0.25 |
| Non-Diabetic + SRP + SPT | Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 3 months | -0.1 mm | Standard Deviation 0.31 |
| Non-Diabetic + SRP + SPT | Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 6 months | -0.07 mm | Standard Deviation 0.26 |
| Non-Diabetic + SRP | Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 3 months | -0.23 mm | Standard Deviation 0.33 |
| Non-Diabetic + SRP | Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics | Baseline to 6 months | -0.19 mm | Standard Deviation 0.29 |
Comparison: Baseline to 3 monthsp-value: 0.44t-test, 2 sided
Comparison: Baseline to 3 monthsp-value: 0.22t-test, 2 sided
Comparison: Baseline to 6 monthsp-value: 0.29t-test, 2 sided
Comparison: Baseline to 6 monthsp-value: 0.15t-test, 2 sided
Secondary
Changes in Fasting Blood Glucose at 6 Months After Treatment
Fasting blood sugar/glucose (FBS/FBG) is tested with a blood sample taken after an overnight fast. A fasting blood sugar level less than 100 mg/dL is normal; a fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes; a level 126 mg/dL (7 mmol/L) or higher on two separate tests, indicates diabetes.
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: SRP + SPT | Changes in Fasting Blood Glucose at 6 Months After Treatment | -2.13 mg/dL | Standard Deviation 32.3 |
| Group B: SRP | Changes in Fasting Blood Glucose at 6 Months After Treatment | 1.85 mg/dL | Standard Deviation 34.68 |
p-value: 0.54t-test, 2 sided
Secondary
Changes in Fasting Blood Glucose at 6 Months After Treatment in Diabetics and Non-diabetics
Fasting blood sugar/glucose (FBS/FBG) is tested with a blood sample taken after an overnight fast. A fasting blood sugar level less than 100 mg/dL is normal; a fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes; a level 126 mg/dL (7 mmol/L) or higher on two separate tests, indicates diabetes.
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: SRP + SPT | Changes in Fasting Blood Glucose at 6 Months After Treatment in Diabetics and Non-diabetics | -5.05 mg/dL | Standard Deviation 46.99 |
| Group B: SRP | Changes in Fasting Blood Glucose at 6 Months After Treatment in Diabetics and Non-diabetics | 2.74 mg/dL | Standard Deviation 46.04 |
| Non-Diabetic + SRP + SPT | Changes in Fasting Blood Glucose at 6 Months After Treatment in Diabetics and Non-diabetics | 0.42 mg/dL | Standard Deviation 7.78 |
| Non-Diabetic + SRP | Changes in Fasting Blood Glucose at 6 Months After Treatment in Diabetics and Non-diabetics | 0.72 mg/dL | Standard Deviation 9.22 |
p-value: 0.58t-test, 2 sided
p-value: 0.64t-test, 2 sided
Secondary
Changes in Hemoglobin A1c at 6 Months After Treatment
Hemoglobin in A1c (HbA1c) tells the average level of blood sugar over the prior 2 to 3 months. Normal level is below 5.7%; 5.7%-6.4% indicates prediabetes; greater than 6.5% is indicative of diabetes.
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: SRP + SPT | Changes in Hemoglobin A1c at 6 Months After Treatment | -0.01 % of hemoglobin a1c | Standard Deviation 0.55 |
| Group B: SRP | Changes in Hemoglobin A1c at 6 Months After Treatment | 0.14 % of hemoglobin a1c | Standard Deviation 0.72 |
p-value: 0.27t-test, 2 sided
Secondary
Changes in Hemoglobin A1c at 6 Months After Treatment in Diabetics and Non-diabetics
Hemoglobin in A1c (HbA1c) tells the average level of blood sugar over the prior 2 to 3 months. Normal level is below 5.7%; 5.7%-6.4% indicates prediabetes; greater than 6.5% is indicative of diabetes.
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: SRP + SPT | Changes in Hemoglobin A1c at 6 Months After Treatment in Diabetics and Non-diabetics | -0.04 % of hemoglobin a1c | Standard Deviation 0.79 |
| Group B: SRP | Changes in Hemoglobin A1c at 6 Months After Treatment in Diabetics and Non-diabetics | 0.30 % of hemoglobin a1c | Standard Deviation 0.92 |
| Non-Diabetic + SRP + SPT | Changes in Hemoglobin A1c at 6 Months After Treatment in Diabetics and Non-diabetics | 0.01 % of hemoglobin a1c | Standard Deviation 0.18 |
| Non-Diabetic + SRP | Changes in Hemoglobin A1c at 6 Months After Treatment in Diabetics and Non-diabetics | -0.07 % of hemoglobin a1c | Standard Deviation 0.2 |
p-value: 0.2t-test, 2 sided
p-value: 0.07t-test, 2 sided
Secondary
Shannon Index of the Subgingival Plaque Microbiome at Baseline and 6 Months
Shannon index represents mean species diversity in a site at a local scale. Shannon index quantifies the uncertainty in predicting the species identity of an individual that is taken at random from the dataset. The minimum value is 0 and there is no maximum value. High values mean high species diversities.
Time frame: Baseline; 6 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: SRP + SPT | Shannon Index of the Subgingival Plaque Microbiome at Baseline and 6 Months | Baseline | 5.31 Shannon index value | Standard Deviation 0.48 |
| Group A: SRP + SPT | Shannon Index of the Subgingival Plaque Microbiome at Baseline and 6 Months | 6 Months | 5.2 Shannon index value | Standard Deviation 0.5 |
| Group B: SRP | Shannon Index of the Subgingival Plaque Microbiome at Baseline and 6 Months | Baseline | 5.27 Shannon index value | Standard Deviation 0.55 |
| Group B: SRP | Shannon Index of the Subgingival Plaque Microbiome at Baseline and 6 Months | 6 Months | 5.34 Shannon index value | Standard Deviation 0.5 |
Comparison: at baselinep-value: 0.7t-test, 2 sided
Comparison: 6 monthsp-value: 0.29t-test, 2 sided