The study is a 56-day (8-week), randomized, controlled, examiner-blinded, parallel-design study of patients with existing Stage II or Stage III periodontitis. After eligibility determination, subjects will be randomized to the following groups: * Group 1: Full mouth periodontal debridement + Emanate Tray (treatment group) * Group 2: Full mouth periodontal debridement alone (control group) Patients will be evaluated at Baseline and on Days 14, 28, and 56 for primary endpoint and at baseline and on day 56 post-treatment for secondary (efficacy) endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
Emanate Tray, a personalized dental tray set (upper and lower) with PVA hydrogel containing 0.05% w/w chlorhexidine gluconate
Forsyth Institute
Cambridge, Massachusetts, United States
Incidence of Treatment-Emergent Adverse Events
The number and percentage of subjects who experience at least 1 treatment-emergent AE (TEAE) and the number and percentage of subjects who experience at least 1 TEAE within each specific system organ class (SOC) and preferred term (PT).
Time frame: 56 days
To evaluate the primary efficacy-effect of Emanate Tray on bleeding and probing (BOP)
The % reduction in sites with BOP
Time frame: 56 days
To evaluate the effect of Emanate Tray on pocket depth (PD) reduction
The mean reduction in pocket depth at Day 56.
Time frame: 56 days
To evaluate the effect of Emanate Tray on clinical attachment level (CAL)
The mean reduction in clinical attachment level at Day 56.
Time frame: 56 days
To evaluate changes in plaque index (PI)
The mean reduction in amount of plaque at Day 56.
Time frame: 56 days
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