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
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
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
Parallel
Topical oxygen-releasing oral gel
DrugScaling 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.
No intervention
Other interventionScaling 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.
Probing pocket depth (PPD)
The distance measured from the gingival margin to the base of the periodontal pocket. This will be assessed at six sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) using a standardised UNC-15 periodontal probe exerted with approximately 0.25 N of probing force. It will be recorded in millimetres.
Clinical Attachment Level (CAL)
The distance measured from a fixed anatomical reference point, the cementoenamel junction (CEJ), to the base of the periodontal pocket. It is calculated using the formula: CAL = PPD + Gingival Recession (or PPD - Gingival Overgrowth). It will be measured at the same six sites per tooth using a standardised UNC-15 probe. It will also be recorded in millimetres.
Bleeding on Probing (BOP)
The presence or absence of provocative capillary bleeding within the sulcus following pocket instrumentation. It will be recorded as a binary outcome ("Yes" if bleeding occurs within 10 seconds of probing, "No" if no bleeding occurs) according to Ainamo \& Bay's Bleeding Index at the evaluated pocket sites (Ainamo \& Bay, 1975).
Plaque Score
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