The purpose of this study is to determine whether ST266 will reduce pocket depth (PD) as an adjunctive to scaling and root planing (SRP) in subjects with moderate to severe periodontal disease.
The study is a 9-month, randomized, double-blind, parallel-design study of subjects with existing moderate to severe periodontal disease randomly assigned to one of three groups. The primary endpoint of PD change will be evaluated following 9 months of treatment. Subjects will be followed for 9 months for safety and radiographic evaluations. Subjects who meet inclusion criteria will be randomized to one of three treatment groups. Randomization will be stratified by site and smoker status (never smoked or quit smoking more than two years ago vs. has smoked within the last two years). Randomization will be blocked such that assignment to treatment groups both within sites and within smoker status will be approximately even (1:1:1). Treatment will be initiated after SRP. All subjects will be evaluated at baseline and Days 1, 15, 30, 60, 90, 180, and 270.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
151
1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
Saline applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. Saline will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
University of Alabama at Birmingham School of Dentistry
Birmingham, Alabama, United States
Oral Health Research Institute
Indianapolis, Indiana, United States
Forsyth Institute
Cambridge, Massachusetts, United States
Columbia University College of Dental Medicine
New York, New York, United States
Changes in Pocket Depth (PD) for Those Pockets ≥ 6 mm at Baseline
The primary efficacy endpoint of this study is the change from baseline in the PD at 9 months (Day 270) for those pockets ≥6 mm at baseline.
Time frame: Baseline; 9 months
Changes in Clinical Attachment Level (CAL)
Change in Clinical Attachment Level (CAL) (the measurement of the position of the soft tissue in relation to the cemento-enamel junction (CEJ) that is a fixed point, using probing depth and the distance from the gingival margin to the CEJ.) from baseline in CAL at 9 months (Day 270) in tooth sites with baseline PD ≥ 6mm.
Time frame: Baseline, 9 months
Bleeding on Probing (BOP)
A secondary efficacy endpoint of this study is change from baseline in BOP at 9 months (Day 270) with BOP for each subject calculated as the percentage of tooth sites in the whole mouth with BOP.
Time frame: Baseline and 9 months
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Stony Brook School of Dental Medicine
Stony Brook, New York, United States
University of North Carolina at Chapel Hill School of Dentistry
Chapel Hill, North Carolina, United States