The goal of this clinical trial is to compare safety and to see if individuals with generalized stage III periodontitis that are given a periodontal hydrogel dressing on a wound healing after plaque and tartar have been removed from teeth have greater healing than individuals who are given no treatment after.
Subjects will have read, understood, and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
Subjects 30 to 75 years of age.
Generalized Stage III periodontitis with at least 8 teeth having interproximal clinical attachment level of ≥3 mm and a probing pocket depth of ≥5 mm and ≤7mm, distributed between the mandible and the maxilla, with at least 2 qualifying interproximal sites in each arch. Localized and not more than 6 sites with a PD of 8 mm is acceptable as long as the tooth with 8 mm pocket depth is not clinically diagnosed as hopeless tooth with suppuration or mobility Grade 3 or greater.5-7
Subjects have a minimum of 24 natural teeth with a minimum of 2 natural teeth per quadrant excluding third molars.
Periodontal surgery, implant placement or SRP within 12 months prior to screening or a cleaning/prophylaxis three months prior to screening.
Presence of fixed or removable (e.g. Invisalign) orthodontic appliances.
Subject with an underlying medical condition which requires antibiotic prophylaxis prior to dental treatment.
Subjects with vesiculobullous processes or other similar chronic oral lesions / conditions resulting in gingival irritation, discomfort/pain, or erosions.
Parallel
Emanate Perio PODS
DeviceEmanate Perio PODS used 2x/day for 30 minutes use
Effectiveness on periodontal wound healing compared to control as evidenced by the presence/absence of gingival bleeding
Change in Bleeding on Marginal Probing (BOMP) over time at 60 Days post non-surgical therapy
Effectiveness on periodontal wound healing compared to control
As evidenced by change in Modified Gingival Index (MGI)
Effectiveness on periodontal wound healing compared to control
As evidenced by change change in Pocket Depth (PD) over time in sites with baseline pockets \>/=4mm
Effectiveness on periodontal wound healing compared to the historical treatment effect of non-surgical therapy
Change in Pocket Depth (PD) over time in sites with baseline pockets \>/=4mm at 60 days post non-surgical therapy
Feasibility of usage of the Emanate Perio PODS twice a day group
Feasibility will be characterized by compliance at Day 15 post non-surgical therapy
Feasibility of usage of the Emanate Perio PODS twice a day group
Feasibility will be characterized by Dropout rate pre-treatment and at day 15 and Day 30
Feasibility of usage of the Emanate Perio PODS twice a day group
Feasibility will be characterized by mouthpiece fit and comfort as measured using the VAS at Day 0 and at Day 15 post non-surgical therapy
Click on the lead sponsor to view all of their trials.
McGuire Institute
Lead sponsor
Emanate Biomedical Inc.
Collaborator
