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.
Periodontitis can be considered a chronic wound, in which the barrier has been compromised allowing pathogenic bacteria to infiltrate the subgingival space. In this study, the Emanate Perio PODS dressing is applied for 30 minutes and overnight immediately after toothbrushing and interdental cleaning to physically protect the healing periodontal pocket from pathogenic bacteria while the epithelium reestablishes itself; which usually takes between 15-30 minutes. By week four post SRP, the epithelium matures enough to withstand the mechanical forces and therefore the treatment can stop. It is hypothesized that during the initial phases of healing, i.e., day 1 to day 30, and in the absence of mechanical forces, the epithelium can protect the subgingival pocket, and Emanate Perio PODS dressing is only applied after toothbrushing and interdental cleaning when tissue is exposed to disruptive mechanical forces. The limited use of the device minimizes the burden of use on patients and aligns with recommended twice daily toothbrushing which can improve treatment adherence and compliance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
111
Emanate Perio PODS used overnight for 14 days post-SRP
Emanate Perio PODS used 2x/day for 30 minutes use
Shoreline Periodontics and Dental Implants
New London, Connecticut, United States
Metro West Orthodontics & Periodontics
La Vista, Nebraska, United States
Perio Health Professionals
Houston, Texas, United States
Gulf Coast Periodontics
Victoria, Texas, United States
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
Time frame: 60 Days post non-surgical therapy
Effectiveness on periodontal wound healing compared to control
As evidenced by change in Modified Gingival Index (MGI)
Time frame: 60 Days post non-surgical therapy
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
Time frame: 60 Days post non-surgical therapy
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Glazier Implants + Periodontics
Richmond, Virginia, United States
Richardson, Overstreet, & White Ltd.
Richmond, Virginia, United States