Cardiovascular Diseases, Diabetes Type 2
Conditions
Keywords
Oral health
Brief summary
Purpose: The Baseline Oral Health Health Study is a randomized controlled trial to evaluate the impact of regular, professional non-surgical Intensive Periodontal Therapy (scaling and root planing and optimal oral hygiene with associated professional oral health behavior advice ), on oral health as well as whether such effects are associated with corresponding changes to biomarkers characterizing systemic health. Participants: The Baseline Oral Health Study will enroll approximately 200 participants in the study with approximately 100 participants each within the Control Group and the Treatment Group. The study population will be recruited from the Project Baseline Health Study participants in the North Carolina region and may be expanded to include subjects recruited from University of North Carolina (UNC) if the initial screening from Project Baseline Health Study pool of participants in the North Carolina region does not fulfill study enrollment powering. Procedures (methods): The study population will be recruited from Project Baseline Health Study participants. The Project Baseline Health Study is a longitudinal cohort study which characterizes participants across clinical, molecular, imaging, sensor, self-reported, behavioral, psychological, environmental, or other health-related measurements from onsite and/or remote visits, continuous monitoring through sensor technology, and regular engagement via an online portal, and mobile app. The study population will be recruited from Project Baseline Health Study participants diagnosed with cardiovascular disease and/or type 2 diabetes mellitus (including prediabetes) and eligible for periodontal intervention. The study will use dental centers and an experienced dental team to manage the oral care provided in this study.
Detailed description
The Baseline Oral Health Health Study is a randomized controlled trial to evaluate the impact of regular, professional non-surgical Intensive Periodontal Therapy (scaling and root planing and optimal oral hygiene with associated professional oral health behavior advice ), on oral health as well as whether such effects are associated with corresponding changes to biomarkers characterizing systemic health. The study will be conducted in partnership with Verily and the Project Baseline Team, Colgate, and the University of North Carolina. The study population will be recruited from Project Baseline Health Study participants. The Project Baseline Health Study is a longitudinal cohort study which characterizes participants across clinical, molecular, imaging, sensor, self-reported, behavioral, psychological, environmental, or other health-related measurements from onsite and/or remote visits, continuous monitoring through sensor technology, and regular engagement via an online portal, and mobile app. The study population will be recruited from Project Baseline Health Study participants diagnosed with cardiovascular disease and/or type 2 diabetes mellitus (including prediabetes) and eligible for periodontal intervention. The study will use dental centers and an experienced dental team to manage the oral care provided in this study.
Interventions
DRUGSubgingival chlorhexidine irrigation
The dose information for the Chlorhexidine gluconate will be 0.12% with 1 mL in each dental pocket at a frequency of every 3 months for the duration of the study (18 months).
OTHERDental Supplies
Subjects in the Treatment Group will receive a commercial electric toothbrush (Colgate hum), toothpaste (Colgate Renewal), mouthwash (Colgate Zero), proxabrush (Colgate), and floss (Colgate Palmolive brand) to be used at home along with instructions on their use. Brush heads for the electric toothbrush will be replaced every 3 months and products (toothpaste, mouthwash, proxabrush, and floss) will be replenished at every site visit.
OTHERPeriodonal Treatment
Initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planing (SRP).
Sponsors
University of North Carolina, Chapel Hill
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The investigator and all sub-investigators will make every effort to remain blinded as to the subject regimen. Periodontal treatment throughout the Study will be provided only by experienced general dentists, periodontists or dental hygienists who are licensed, trained and calibrated prior to the start of the study. In order to maintain examiner blinding throughout the study, the treatment provider will be a person other than the dental examiner and will exclusively provide treatment and not participate in patient assessments.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least eighteen (18) years of age but not older than seventy (70) years of age at the time of screening * Able to speak and read English * Has at least 16 teeth present. * Able to consent, follow an outpatient protocol, and is available by telephone * Has either moderate (stage II) or severe (stage III) periodontitis: * Stage II - Interdental clinical attachment level (CAL) at the site of greatest loss = 3 to 4mm with maximum probing depth ≤ 5mm * Stage III - Interdental CAL at the site of greatest loss ≥ 5mm, probing depth (PD)≥ 6mm, and radiographic bone loss (vertical bone loss ≥ 3mm) * Has at least one of the following indicators of cardiometabolic disease in the following range: * Type 2 diabetes: 9% ≥ HbA1c ≥ 6.5% OR Prediabetes: 6.4%≥ HbA1c ≥ 5.7% OR * Cardiovascular Disease (CVD): * Medical history of Myocardial Infarction, Coronary Artery Disease or stroke * Access to Apple (iOS) devices or Android devices with appropriate versions to be compatible with the applications to complete study procedures. * Females of childbearing capacity must be willing to have pregnancy test
Exclusion criteria
* Individuals who exhibit gross oral pathology * Presenting oral manifestations of systemic diseases (e.g. pemphigus, pemphigoid, lupus) * Presence of any acute or chronic systemic infection as determined by the clinician * Periodontal treatment performed within 6 months prior to study start * Refusal to extract hopeless teeth identified as determined by the clinician at the screening visit. * Participating in any other interventional cardiometabolic or Oral Health study * Individuals currently undergoing any type of orthodontic treatment (e.g. aligners)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Treatment on Change in Oral Health Measures | Comparing T1 (day 90) and T4 (day 360) | The impact of treatment on oral health measures, will be performed using generalized estimating equations (GEE) methods. Longitudinal outcomes in the Treated vs. Control groups will be compared and will include all subjects who were randomized and their data from visits T1 - T4 based on intent-to-treat (ITT) group assignment. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health. |
| Association Between Changes in Oral Health (Probing Depth) and Changes in Systemic Health (HbA1c) | Comparing T0 (day 0) and T4 (day 360) | The association between changes in oral health and changes in systemic health, will be evaluated using correlation analysis. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health. The correlation between % change in whole-mouth mean probing depth and % change in HbA1c will be determined in subjects with prediabetes or type 2 diabetes at screening. |
| Association Between Changes in Oral Health and Changes in Systemic Health (Flow-mediated Dilation) | Comparing T0 (day 0) and T4 (day 360) | The association between changes in oral health and changes in systemic health, will be evaluated using correlation analysis. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health. The correlation between % change in whole-mouth mean probing depth and change in flow-mediated dilation will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Emotional Wellbeing | Comparing T0 (day 0) and T4 (day 360) | Emotional wellbeing will be evaluated through the use of PANAS (Positive Affect and Negative Affect Scales). PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure is change in the 10 item positive affect subscale. |
| Change in Beliefs About Periodontal Disease | Comparing T0 (day 0) and T4 (day 360) | Beliefs about periodontal disease will be evaluated through the use of a Protective Motivation Theory (PMT) survey. PMT surveys assess an individual's motivation to adopt protective health behaviors by focusing on specific cognitive processes. This survey includes 7 statements related to opinions on periodontal disease and treatment (e.g., "Periodontal disease worries me," "Adhering to my periodontal treatment instructions over the next weeks will improve my oral health"). Each survey item is scored from 1 to 10 with 1 being "not at all" to 10 being "extremely so." Higher values indicate stronger agreement with the survey statements. Reported outcome measures represent total survey scores (range from 7 to 70). |
| Change in Bleeding on Probing | Comparing T0 (day 0) and T4 (day 360) | Whole-mouth mean of tooth-specific dichotomic response (bleeding = 1, no bleeding = 0) after probing the gingival sulcus. |
| Change in Gingival Index | Comparing T0 (day 0) and T4 (day 360) | The gingival index will be scored on three facial surfaces (distofacial, facial, mesiofacial) and three lingual surfaces (distolingual, lingual, mesiolingual). Areas are examined by placing the periodontal probe under the gingival margin at approximately 1mm deep and sweeping the probe from the distal surface to the mesial surface in quadrants I and IV and mesial to the distal surface in quadrants II and III. After each quadrant is swept, calls are made based on gingival inflammation and the presence or absence of bleeding according to criteria which range from 0 to 3. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation. For this Outcome Measure, less inflammation (lower number) correlates with better outcome. Reported outcome measure is whole-mouth mean value (six surfaces of each tooth), with a range of 0 to 3. |
| Percent Change in Clinical Attachment Level (CAL) | Comparing T0 (day 0) and T4 (day 360) | Percent change of whole-mouth mean clinical attachment level (CAL, defined as measured pocket depth - gingival margin, for each site). Percent change calculated as (CAL@T4 - CAL@T0)/CAL@T0. |
| Change in Dental Plaque Index | Comparing T0 (day 0) and T4 (day 360) | Change of digitally measured interdental plaque area. Full mouth plaque assessment shall be assessed using the UNC Modified Plaque Index (Greene and Vermillion). Plaque scores shall be visually assessed at 6 sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual surfaces) on a scale of 0-3. Scores are the following: 0 =No debris or stain present on the clinical crown; 1 =Soft debris covering not more than 1/3 of the clinical crown (cervical 3rd), or presence of extrinsic stains without other debris regardless of surface area covered; 2 =Soft debris covering more than 1/3, but not more than 2/3 (middle 3rd) of the clinical crown; 3 =Soft debris covering more than 2/3 of the clinical crown. Reported outcome measure is calculated as whole-mouth mean (mean of each site at each tooth) with a range of 0 to 3. |
| Change in Flow-mediated Dilation | Comparing T0 (day 0) and T4 (day 360) | Change of flow mediated dilation. Ultrasound images of the right brachial artery and Doppler measures of arterial flow will be acquired before and after reactive hyperemia is induced by inflating a pneumatic occlusion cuff placed around the lower arm. FMD will be calculated as the percent change in arterial diameter from baseline. |
| Percent Change in Glycated Hemoglobin (HbA1c) (Prediabetic and Type 2 Diabetic Cohorts) | Comparing T0 (day 0) and T4 (day 360) | Percent change of HbA1c (% glycated) from day 0 to day 360 \[(HbA1c@T4 - HbA1c@T0) / HbA1c@T0\] in the prediabetic and diabetic cohorts (HbA1c \>= 5.7 at screening) |
| Percent Change in Carotid Intima Media Thickness (IMT) | Comparing T0 (day 0) and T4 (day 360) | Percent change of IMT. Longitudinal ultrasound images of the distal 1 cm segments of the right and left common carotid arteries, carotid bulbs, and internal carotid arteries will be acquired. IMT will be measured as the distance between luminal-intimal interface and medial-adventitial interface. Mean IMT will be calculated as the average of all measurements; mean maximum IMT will be calculated as the average of maximum wall thicknesses for each of the regions. Percent change of IMT (mm) from day 0 to day 360 is calculated as (IMT@T4 - IMT@T0) / IMT@T0\] |
| Percent Change of High Sensitivity C-reactive Protein (Hs-CRP) | Comparing T0 (day 0) and T4 (day 360) | Percent change of hs-CRP (mg/dL) from day 0 to day 360 \[(CRP@T4 - CRP@T0) / CRP@T0\] |
| Percent Change in Total Cholesterol | Comparing T0 (day 0) and T4 (day 360) | Percent change of total cholesterol (mg/dL) from day 0 to day 360 \[(tchol@T4 - tchol@T0) / tchol@T0\] |
| Percent Change in Low Density Lipoprotein (LDL) Cholesterol | Comparing T0 (day 0) and T4 (day 360) | Percent change of low density lipoproteins (LDL) cholesterol (mg/dL) from day 0 to day 360 \[(LDL@T4 - LDL@T0) / LDL@T0\] |
| Percent Change in Triglycerides | Comparing T0 (day 0) and T4 (day 360) | Percent change of triglycerides (mg/dL) from day 0 to day 360 \[(trig@T4 - trig@T0) / trig@T0\] |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSaroja Voruganti, PhD
University of North Carolina, Chapel Hill
Participant flow
Pre-assignment details
Of the 786 participants who signed informed consent, 194 completed the required assessments, and remained eligible. Of the 194 eligible participants, 39 declined to be randomized. Of the 155 randomized participants, two did not continue following randomization and did not receive any exposure to a study intervention.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 138 Participants |
| Diabetes/pre-diabetes Non-prediabetes/non-diabetes ( HbA1c < 5.7 at screening) | 16 Participants |
| Diabetes/pre-diabetes Prediabetes/diabetes ( HbA1c >=5.7 at screening) | 57 Participants |
| Diabetes/pre-diabetes Uncategorized (HbA1c not recorded at screening or T0) | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 36 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 63 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 73 | 0 / 80 |
| other Total, other adverse events | 0 / 73 | 0 / 80 |
| serious Total, serious adverse events | 1 / 73 | 0 / 80 |
Outcome results
None listed