Trial Outcomes & Findings for Effect of Locally-Applied Simvastatin on Clinical Attachment Level and Alveolar Bone in Periodontal Maintenance Patients (NCT NCT03452891)
NCT ID: NCT03452891
Last Updated: 2023-10-05
Results Overview
The change in CAL will be measured and calculated by measuring recession and subtracting the periodontal probing depth.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
The CAL will be measured at 12-months.
Results posted on
2023-10-05
Participant Flow
Participant milestones
| Measure |
SIM-MCL
Simvastatin-Methylcellulose: Simvastatin-Methylcellulose gel will be placed in a deep (6-9 mm) periodontal pocket.
|
Methylcellulose Gel
Methylcellulose: Methylcellulose gel will be placed in a deep (6-9 mm) periodontal pocket.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
Subjects Enrolled
|
25
|
25
|
|
Overall Study
Subjects Completing Study
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
SIM-MCL
n=25 Participants
Simvastatin-Methylcellulose: Simvastatin-Methylcellulose gel will be placed in a deep (6-9 mm) periodontal pocket.
|
Methylcellulose Gel
n=25 Participants
Methylcellulose: Methylcellulose gel will be placed in a deep (6-9 mm) periodontal pocket.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=25 Participants
|
20 Participants
n=25 Participants
|
37 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=25 Participants
|
5 Participants
n=25 Participants
|
13 Participants
n=50 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=25 Participants
|
20 Participants
n=25 Participants
|
38 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=25 Participants
|
5 Participants
n=25 Participants
|
12 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: The CAL will be measured at 12-months.The change in CAL will be measured and calculated by measuring recession and subtracting the periodontal probing depth.
Outcome measures
| Measure |
SIM-MCL
n=25 Participants
Simvastatin-Methylcellulose: Simvastatin-Methylcellulose gel will be placed in a deep (6-9 mm) periodontal pocket.
|
Methylcellulose Gel
n=25 Participants
Methylcellulose: Methylcellulose gel will be placed in a deep (6-9 mm) periodontal pocket.
|
|---|---|---|
|
Change in Clinical Attachment Level (CAL)
|
7.0 millimeters
Standard Error 0.1
|
6.9 millimeters
Standard Error 0.2
|
Adverse Events
SIM-MCL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Methylcellulose Gel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place