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NCT07840859
Clinical Effectiveness of Oxygen-Releasing Oral Gel as an Adjunct to Scaling and Root Debridement in Patients With Severe Periodontal Pockets: A Randomized Clinical Trial
Conditions: Periodontitis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 38
Sponsor: Universiti Sains Malaysia
Location: School of Dental Sciences, Health Campus, Universiti Sains Malaysia Kota Bharu Kelantan
Summary
The goal of this clinical trial is to learn if adding an oxygen-releasing gel to a deep dental cleaning treatment can improve gum health more than deep cleaning alone, in adults with severe gum disease. The main questions it aims to answer are:
1. Does adding oxygen-releasing gel to deep cleaning reduce the depth of gum pockets more than deep cleaning alone?
2. Does adding oxygen-releasing gel to deep cleaning lead to greater improvement in gum attachment, less gum recession, less plaque, and less bleeding, compared to deep cleaning alone?
3. Do any improvements last for up to 6 months?
Researchers will compare one side of each participant's mouth, treated with deep cleaning plus oxygen-releasing gel, to the other side, treated with deep cleaning alone, to see if adding the gel produces a bigger and longer-lasting improvement in gum health.
Participants will:
* Attend 5 visits over 6 months
* Receive deep cleaning (scaling and root debridement) on both sides of the mouth at visits where it is needed
* Have one side of the mouth randomly chosen, using a method similar to drawing lots, to also receive the oxygen-releasing gel
* Receive the gel twice: once at the first visit, and again one week later
* Have their gum measurements checked at each visit
Eligibility Criteria
Inclusion Criteria:
* Systemically healthy individuals or individuals with a well-controlled systemic condition
* Individuals 18 years of age or older
* No restrictions on gender
* Individuals diagnosed with periodontitis and present with a localised or generalised distribution of deep pockets
* There is presence of more than one qualifying severe periodontal pocket measuring ≥ 6 mm
* There must be at least two qualifying severe pocket profiles present (one for the experimental site and one for the active control site)
Exclusion Criteria:
* Individuals who have received any form of non-surgical or surgical periodontal therapy within the past 6 months
* Smokers or tobacco chewers
* Pregnant or lactating mothers
* Individuals who have received systemic antibiotic therapy within the past 3 months
* Individuals who require prophylactic antibiotic coverage prior to dental procedures
* Individuals who are currently using topical antiseptics
* Currently on antiplatelet or anticoagulant therapy
* Individual with bleeding disorder
Source: ClinicalTrials.gov (NCT07840859). StuddyBuddy aggregates publicly available trial information.