A Clinical Trial Comparing 2x/Day for 30-minutes Use of the Emanate Perio PODS Post-SRP to a Cont… (NCT06914596) | Clinical Trial Compass
RecruitingNot Applicable
A Clinical Trial Comparing 2x/Day for 30-minutes Use of the Emanate Perio PODS Post-SRP to a Control Group Post-SRP.
United States72 participantsStarted 2026-02-19
Plain-language summary
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.
Who can participate
Age range30 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
✓. All supragingival accretions can be removed from below the height of contour of the tooth crown to allow for a comprehensive periodontal evaluation and accurate intraoral digital scan of both arches at screening.
✓. Subjects agree to refrain from use of oral rinses or dentifrice with known antibacterial properties (e.g., Peridex®, Listerine®, Colgate Total®, Crest Pro-Health®, etc.).
✓. Subjects agree to refrain from use of electric flossers or irrigation devices for the duration of the study.
✓. Subjects can provide self-care (oral hygiene) without disabilities requiring assistance with daily oral hygiene measures.
Exclusion criteria
✕. Periodontal surgery, implant placement or SRP within 12 months prior to screening or a cleaning/prophylaxis three months prior to screening.
What they're measuring
1
Effectiveness on periodontal wound healing compared to control as evidenced by the presence/absence of gingival bleeding
✕. 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.
✕. Subjects with soft or hard tissue tumor(s) of oral cavity.
✕. Use of any smoked substances such as tobacco / cannabis including cigarettes, vape, cigars, or use of smokeless tobacco 30 days prior to screening and throughout the study.
✕. Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, cancer).
✕. Subjects who are lactating or pregnant or planning to become pregnant through their projected study duration.