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Not yet recruitingNCT07840859Updated Sep 30, 2026

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

An interventional study of Topical oxygen-releasing oral gel and No intervention in Periodontitis, sponsored by Universiti Sains Malaysia. Not yet recruiting at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Primary conditionPeriodontal PocketRegistry: PeriodontitisReclassifiedWhy we changed it
Registry
Periodontitis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Periodontal Pocket
Why
  1. The study's title name Periodontal Pocket, a narrower term within Periodontitis.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Universiti Sains Malaysia · Not applicable, Interventional, and Treatment

Updated Sep 25, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Periodontitis

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Keywords

  • Periodontitis
  • Severe periodontal pockets
  • Scaling and root debridement (SRD)
  • Non-surgical periodontal therapy
  • Oxygen-releasing oral gel
  • Adjunctive periodontal therapy
03

In context

Periodontal Pocket Reclassified

130 studies on the registry are indexed under Periodontal Pocket; 35 are open to participants now.

This study's planned enrollment of 38 is above the median of 30 across 113 interventional studies indexed under Periodontal Pocket.

Browse Periodontal Pocket studies →

Lead sponsor

Universiti Sains Malaysia is the lead sponsor of 177 studies on the registry; 51 are open to participants now.

Compared within Periodontal Pocket, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Periodontitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
38 participants (estimated)

Study arms

  • Active comparator
    Control Group

    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

  • Experimental
    Test Group

    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

  • DrugTopical 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.

  • OtherNo 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.

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

Secondary outcomes

  1. 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).

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

  2. Plaque Score

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

07

Study locations

1 site
  • School of Dental Sciences, Health Campus, Universiti Sains Malaysia
    Kota Bharu, Kelantan 16150, Malaysia
08

Updates

2 registry updates since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Sep 25, 2026
Show all 2 updates
  1. Sep 30, 2026
    Minor edits only
    + 1 other change: responsible party
  2. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07840859
Responsible party
Anis Izzati binti Abdul Aziz (Principal Investigator, Universiti Sains Malaysia) — Principal investigator
First posted
Sep 25, 2026
Start date
Nov 2026 (estimated)
Primary completion
Mar 2028 (estimated)
Completion
Mar 2028 (estimated)
Last update
Sep 30, 2026

Study contacts

Anis Izzati Abdul Aziz
Contact
anisizzati2804@gmail.com
+6017-2512534

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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