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NOT YET RECRUITING
NCT07840859
NA

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

Sponsor: Universiti Sains Malaysia

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2026-11

Completion Date

2028-03

Last Updated

2026-09-25

Healthy Volunteers

No

Conditions

Interventions

DRUG

Topical oxygen-releasing oral gel

Scaling and root debridement (RSD), a standard non-surgical periodontal procedure involving mechanical removal of subgingival plaque and calculus using ultrasonic and/or hand instrumentation. RSD will be performed at baseline on all sites (both test and control), and repeated at 6 weeks, 3 months, and 6 months if clinically indicated based on residual probing pocket depth or bleeding on probing. BlueM® oral gel is a topical oxygen-releasing oral gel, containing sodium perborate and lactoferrin as active ingredients. The gel will be applied subgingivally to the test site immediately following scaling and root debridement at baseline, and reapplied once more at the 1-week follow-up visit. No further gel application will occur after week 1.

OTHER

No intervention

Scaling and root debridement (RSD), a standard non-surgical periodontal procedure involving mechanical removal of subgingival plaque and calculus using ultrasonic and/or hand instrumentation. RSD will be performed at baseline on all sites (both test and control), and repeated at 6 weeks, 3 months, and 6 months if clinically indicated based on residual probing pocket depth or bleeding on probing. The control arm receive the standard treatment and will not be receiving any placebo gel.

Locations (1)

School of Dental Sciences, Health Campus, Universiti Sains Malaysia

Kota Bharu, Kelantan, Malaysia