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

NCT07840859 | Not Yet Recruiting

• 2 other identifiers: USM/JEPeM/KK/26080719RSCH ID-26-05396-JJZ
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Conditions

Periodontitis

Keywords

Periodontitis; Severe periodontal pockets; Scaling and root debridement (SRD); Non-surgical periodontal therapy; Oxygen-releasing oral gel; Adjunctive periodontal therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  Will be measured at: Baseline, at 6-weeks, at 3-months and at 6-months review

• 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.

  Will be measured at: Baseline, at 6-weeks, at 3-months and at 6-months review

Secondary Outcomes (2)

• Bleeding on Probing (BOP)

  Will be measured at: Baseline, at 6-weeks, at 3-months and at 6-months review

• Plaque Score

  Will be measured at: Baseline, at 6-weeks, at 3-months and at 6-months review

Study Arms (2)

Control Group

ACTIVE COMPARATOR

This study will involve 2 arms in every patient since it will be a split-mouth study. The first arm (control site) will involve standard treatment (scaling and root debridement) for periodontitis.

Other: No intervention

Test Group

EXPERIMENTAL

This study will involve 2 arms in every patient since it will be a split-mouth study. The test arm is the second arm in the same patient but at a different tooth site (test site) which will receive standard treatment plus adjunctive therapy (oxygen-releasing oral gel / blue®m Oral Gel).

Drug: Topical oxygen-releasing oral gel

Interventions

Topical oxygen-releasing oral gel DRUG

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.

Test Group

No intervention OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

School of Dental Sciences, Health Campus, Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

Location

MeSH Terms

Conditions

Periodontitis; Periodontal Pocket

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Anis Izzati Abdul Aziz

CONTACT

+6017-2512534; anisizzati2804@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-09

Locations

MY (1)