PeriodontitisNCT07840859
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
A study testing Topical oxygen-releasing oral gel in people with Periodontitis, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Topical oxygen-releasing oral gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteMalaysia
- Study dates
- Nov 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
School of Dental Sciences, Health Campus, Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150
Anis Izzati Abdul Aziz, +017-2512534, anisizzati2804@gmail.com
About this study
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:
- Does adding oxygen-releasing gel to deep cleaning reduce the depth of gum pockets more than deep cleaning alone?
- 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?
- Do any improvements last for up to 6 months?
Read more
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
- Conditions
- Periodontitis
- Being tested
- Topical oxygen-releasing oral gel, No intervention
- Keywords
- Periodontitis, Severe periodontal pockets, Scaling and root debridement (SRD), Non-surgical periodontal therapy, Oxygen-releasing oral gel, Adjunctive periodontal therapy
- Medical subject headings
- Periodontitis, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical oxygen-releasing oral gelDrug
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.
No interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: Topical oxygen-releasing oral gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Will be measured at: Baseline, at 6-weeks, at 3-months and at 6-months review
Secondary outcomes (2)
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).
Measured: Will be measured at: Baseline, at 6-weeks, at 3-months and at 6-months review
Plaque Score
Measured: Will be measured at: Baseline, at 6-weeks, at 3-months and at 6-months review
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anis Izzati binti Abdul Aziz, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840859
- Sponsor's protocol ID
- USM/JEPeM/KK/26080719
- Other IDs
- RSCH ID-26-05396-JJZ
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07840859
- Acronym / sponsor ID
- USM/JEPeM/KK/26080719
- Conditions
- Periodontitis
- Keywords
- Periodontitis, Severe periodontal pockets, Scaling and root debridement (SRD), Non-surgical periodontal therapy, Oxygen-releasing oral gel, Adjunctive periodontal therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does adding oxygen-releasing gel to deep cleaning reduce the depth of gum pockets more than deep cleaning alone?
- 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?
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: No interventionThis 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. |
| Test Group | Experimental | Drug: Topical oxygen-releasing oral gelThis 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical oxygen-releasing oral gelScaling 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. | Drug | Test Group |
| No 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. | Other | Control Group |
Primary outcome
Probing pocket depth (PPD)
Time frame: Will be measured at: Baseline, at 6-weeks, at 3-months and at 6-months review
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)
Time frame: Will be measured at: Baseline, at 6-weeks, at 3-months and at 6-months review
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.
2 secondary outcomes
Bleeding on Probing (BOP)
Time frame: Will be measured at: Baseline, at 6-weeks, at 3-months and at 6-months review
Plaque Score
Time frame: Will be measured at: Baseline, at 6-weeks, at 3-months and at 6-months review
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical oxygen-releasing oral gel in people with Periodontitis, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anis Izzati Abdul Aziz (+6017-2512534, anisizzati2804@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing pocket depth (PPD) (time frame: Will be measured at: Baseline, at 6-weeks, at 3-months and at 6-months review). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.