Periodontitis
Conditions
Brief summary
The aim of this controlled study is to assess the clinical outcomes and patient reported outcomes of using minimally invasive surgical procedure with Straumann Emdogain as an adjunct (test treatment) or without Straumann Emdogain (control treatment).
Detailed description
The aim of the study will be achieved through the following primary and secondary objectives. The primary objective is to evaluate the regenerative potential of Straumann Emdogain by comparing the change in clinical attachment level from baseline to 12 months between the test and control arms. The regenerative potential of Straumann Emdogain will also be assessed by comparing the changes in gingival margins, changes in average probing pocket depth, changes in full mouth plaque score, changes in bleeding on probing, and changes in root dentin hypersensitivity from baseline to 12 months between the test and control arms.
Interventions
PROCEDUREScaling and root planing
Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw.
PROCEDUREScaling and root planing without Emdogain
Using minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw.
DEVICEEmdogain application
Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw
Sponsors
Institut Straumann AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects must have voluntarily signed the informed consent form before any study related procedures * Subjects must be males or females who are 18-85 years of age * Subjects must have moderate to severe chronic, generalized periodontitis with pockets of 5 mm - 8mm probing depth in at least 2 pockets per contralateral quadrants in one arch (study teeth) * Subjects must be committed to the study and the required follow-up visits * Subjects must be in good general health as assessed by the Investigator
Exclusion criteria
* Subjects taking or intending to take any medications during the duration of the study that will potentially affect healing and inflammation * Subjects who are currently heavy smokers (defined \>10 cigarettes per day or \>1 cigar per day) or who use chewing tobacco * Subjects being treated with systemic antibiotics or subjects that were treated with systemic antibiotics within 3 months prior to treatment in this study * Subjects with uncontrolled diabetes * Subjects that are immunocompromised or immunosuppressed * Subjects that cannot provide informed consent * Subjects with drug or alcohol abuse * Subjects that have undergone periodontal root planing or periodontal surgery in the last 6 months * Subjects that are pregnant * Subjects with necrotizing periodontitis or periodontitis related to systemic disease * Teeth with pockets with probing depth ≥ 9 mm will not classify as study teeth * Teeth with pockets or defects with furcation involvement will not classify as study teeth * Teeth with mobility degree \> 1 without splint will not classify as study teeth * Subjects with test and control sites in the two quadrants on adjacent teeth * Patients with compromised health conditions such as diabetes, systemic diseases, high dose steroid therapy, bone metabolic diseases, radiation or immune-oppressive therapy, and infections or vascular impairment at the surgical site * Subjects with conditions or circumstances, in the opinion of the Investigator , which would prevent completion of study participation or interfere with analysis of study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Attachment Levels (CAL) | Baseline and 12 Month Follow-Up Visit | CAL will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of CAL from baseline measurements at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of CAL for test and control treatment arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pocket Probing Depth (PPD) | Baseline and 12 Month Follow-Up Visit | PPD will be measured in millimeters on the study teeth in 6 locations. Outcome is mean change of PPD from baseline at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth at baseline. Analysis will compare the mean change of PPD for test and control treatment arms. |
| Change in Full Mouth Plaque Score (FMPS) | Baseline and 12 Month Follow-Up Visit | FMPS will be calculated based on the number of tooth surfaces with plaque over the total number of tooth surfaces x 100. The value is presented as a percent. The difference in FMPS between 12 months and baseline will be determined. |
| Change in Gingival Margin (GM) | Baseline and 12 Month Follow-Up Visit | GM will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of GM from baseline at surgery to 12-months-post surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of GM for test and control treatment arms. |
| Change in Root Dentin Hypersensitivity | Baseline and 12 Month Follow-Up Visit | Presence of root dentin hypersensitivity will be recorded as none (no reaction from the subject), mild (sensible with no pain), moderate (sensible with slight pain), or severe (sensible with pain that persists for a while) after a conventional air blast is applied to the study tooth. Changes in the frequency of categories will be determined and compared between the two treatment arms. An improvement is defined as a decreased reaction (for example, severe to mild), a deterioration is defined as increased reaction (for example, none to moderate), and unchanged is no change to reaction (for example, mild to mild). |
| Change in Post-surgical Pain | 1-2 days post surgery, 1 week post surgery, and 2 weeks post surgery | Post-surgical pain will be measured on a 100 millimeter visual analog scale. The range is 0 (no pain) to 99 (nearly maximum pain). The lower the value, the better the outcome. The subjects will be instructed to mark their level of pain on a line for both the test quadrant and the control quadrant. The average change in pain level will be determined and compared between the two arms. |
| Change in Bleeding on Probing (BoP) | Baseline and 12 Month Follow-Up Visit | For the categorical variable BoP, the frequency of bleeding (present or absent) will be counted (absolute and in percent) over all measured sites around the identified study teeth for each treatment group. The results will be compared between the 12-month follow-up and baseline. |
Countries
Canada, Germany, United States
Participant flow
Pre-assignment details
Oversight. 1 extra patient was enrolled.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants assigned to receive both interventions (i.e., control and test) in different quadrants of the jaw.
\- Test Treatment (Scaling and root planing with Emdogain): Scaling and root planing: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw.
Emdogain application: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw.
\- Control Treatment (Scaling and root planing): Scaling and root planing: Using minimally invasive surgical procedure (scaling and root planing) to treat one contra-lateral quadrant in subject's jaw. | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Customized <18 | 0 Participants |
| Age, Customized 18-85 | 51 Participants |
| Age, Customized >85 | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 45 Participants |
| Region of Enrollment Canada | 4 participants |
| Region of Enrollment Germany | 15 participants |
| Region of Enrollment United States | 32 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 15 / 51 |
| serious Total, serious adverse events | 1 / 51 |
Outcome results
Primary
Change in Clinical Attachment Levels (CAL)
CAL will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of CAL from baseline measurements at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of CAL for test and control treatment arms.
Time frame: Baseline and 12 Month Follow-Up Visit
Population: The ITT data set with imputation of missing values (five CAL values were missing at 12 month follow-up and were replaced with values from 9 month follow-up).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (With Emdogain) | Change in Clinical Attachment Levels (CAL) | -2.2 mm | Standard Deviation 1.5 |
| Control (Without Emdogain) | Change in Clinical Attachment Levels (CAL) | -2.1 mm | Standard Deviation 1.3 |
Secondary
Change in Bleeding on Probing (BoP)
For the categorical variable BoP, the frequency of bleeding (present or absent) will be counted (absolute and in percent) over all measured sites around the identified study teeth for each treatment group. The results will be compared between the 12-month follow-up and baseline.
Time frame: Baseline and 12 Month Follow-Up Visit
Population: ITT data set.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Test (With Emdogain) | Change in Bleeding on Probing (BoP) | 12 month sites without bleeding | 797 Sites |
| Test (With Emdogain) | Change in Bleeding on Probing (BoP) | Baseline sites without bleeding | 455 Sites |
| Test (With Emdogain) | Change in Bleeding on Probing (BoP) | 12 month sites with bleeding | 172 Sites |
| Test (With Emdogain) | Change in Bleeding on Probing (BoP) | Baseline sites with bleeding | 547 Sites |
| Control (Without Emdogain) | Change in Bleeding on Probing (BoP) | 12 month sites without bleeding | 743 Sites |
| Control (Without Emdogain) | Change in Bleeding on Probing (BoP) | Baseline sites with bleeding | 576 Sites |
| Control (Without Emdogain) | Change in Bleeding on Probing (BoP) | 12 month sites with bleeding | 223 Sites |
| Control (Without Emdogain) | Change in Bleeding on Probing (BoP) | Baseline sites without bleeding | 450 Sites |
Secondary
Change in Full Mouth Plaque Score (FMPS)
FMPS will be calculated based on the number of tooth surfaces with plaque over the total number of tooth surfaces x 100. The value is presented as a percent. The difference in FMPS between 12 months and baseline will be determined.
Time frame: Baseline and 12 Month Follow-Up Visit
Population: ITT data set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test (With Emdogain) | Change in Full Mouth Plaque Score (FMPS) | Baseline | 54.34 Full Mouth Plaque Score |
| Test (With Emdogain) | Change in Full Mouth Plaque Score (FMPS) | 12 Month Follow Up | 35.03 Full Mouth Plaque Score |
| Control (Without Emdogain) | Change in Full Mouth Plaque Score (FMPS) | Baseline | 55.17 Full Mouth Plaque Score |
| Control (Without Emdogain) | Change in Full Mouth Plaque Score (FMPS) | 12 Month Follow Up | 31.58 Full Mouth Plaque Score |
Secondary
Change in Gingival Margin (GM)
GM will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of GM from baseline at surgery to 12-months-post surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of GM for test and control treatment arms.
Time frame: Baseline and 12 Month Follow-Up Visit
Population: from the ITT dataset. Missing data was not entered.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (With Emdogain) | Change in Gingival Margin (GM) | -.3 mm | Standard Deviation 0.9 |
| Control (Without Emdogain) | Change in Gingival Margin (GM) | -.2 mm | Standard Deviation 1 |
Secondary
Change in Pocket Probing Depth (PPD)
PPD will be measured in millimeters on the study teeth in 6 locations. Outcome is mean change of PPD from baseline at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth at baseline. Analysis will compare the mean change of PPD for test and control treatment arms.
Time frame: Baseline and 12 Month Follow-Up Visit
Population: ITT dataset.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (With Emdogain) | Change in Pocket Probing Depth (PPD) | -2.4 mm | Standard Deviation 1.3 |
| Control (Without Emdogain) | Change in Pocket Probing Depth (PPD) | -2.3 mm | Standard Deviation 1.2 |
Secondary
Change in Post-surgical Pain
Post-surgical pain will be measured on a 100 millimeter visual analog scale. The range is 0 (no pain) to 99 (nearly maximum pain). The lower the value, the better the outcome. The subjects will be instructed to mark their level of pain on a line for both the test quadrant and the control quadrant. The average change in pain level will be determined and compared between the two arms.
Time frame: 1-2 days post surgery, 1 week post surgery, and 2 weeks post surgery
Population: ITT dataset.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (With Emdogain) | Change in Post-surgical Pain | Pain level 1 week post sx | 9.8 mm | Standard Deviation 20.6 |
| Test (With Emdogain) | Change in Post-surgical Pain | Pain Level 1-2 days post sx. | 14.3 mm | Standard Deviation 22.6 |
| Test (With Emdogain) | Change in Post-surgical Pain | Pain Level 2 weeks post sx. | 6.0 mm | Standard Deviation 16.6 |
| Control (Without Emdogain) | Change in Post-surgical Pain | Pain Level 1-2 days post sx. | 12.9 mm | Standard Deviation 20.9 |
| Control (Without Emdogain) | Change in Post-surgical Pain | Pain level 1 week post sx | 8.1 mm | Standard Deviation 19.6 |
| Control (Without Emdogain) | Change in Post-surgical Pain | Pain Level 2 weeks post sx. | 5.0 mm | Standard Deviation 13.8 |
Secondary
Change in Root Dentin Hypersensitivity
Presence of root dentin hypersensitivity will be recorded as none (no reaction from the subject), mild (sensible with no pain), moderate (sensible with slight pain), or severe (sensible with pain that persists for a while) after a conventional air blast is applied to the study tooth. Changes in the frequency of categories will be determined and compared between the two treatment arms. An improvement is defined as a decreased reaction (for example, severe to mild), a deterioration is defined as increased reaction (for example, none to moderate), and unchanged is no change to reaction (for example, mild to mild).
Time frame: Baseline and 12 Month Follow-Up Visit
Population: ITT data set study teeth. Baseline collected at either visit 1 or visit 2 based on different versions of CIP.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Test (With Emdogain) | Change in Root Dentin Hypersensitivity | Improvement in Root Dentin Hypersensitivity | 44 Study Teeth |
| Test (With Emdogain) | Change in Root Dentin Hypersensitivity | Unchanged Root Dentin Hypersensitivity | 107 Study Teeth |
| Test (With Emdogain) | Change in Root Dentin Hypersensitivity | Deterioration in Root Dentin Hypersensitivity | 8 Study Teeth |
| Control (Without Emdogain) | Change in Root Dentin Hypersensitivity | Improvement in Root Dentin Hypersensitivity | 37 Study Teeth |
| Control (Without Emdogain) | Change in Root Dentin Hypersensitivity | Deterioration in Root Dentin Hypersensitivity | 13 Study Teeth |
| Control (Without Emdogain) | Change in Root Dentin Hypersensitivity | Unchanged Root Dentin Hypersensitivity | 106 Study Teeth |