Official title: Comparative Efficacy of Active Oxygen Gel Versus Chlorhexidine Gel as an Adjunct to Subgingival Instrumentation in the Treatment of Stage II Grade B Periodontitis: A Randomized Controlled Clinical Trial With Biomarkers Assessment.

This randomized controlled clinical trial will evaluate the effectiveness of locally delivered active oxygen gel and chlorhexidine gel as adjuncts to scaling and root planing in the treatment of stage II grade B periodontitis.Sixty participants will be randomly assigned to one of three parallel groups: SRP with placebo gel, SRP with active oxygen gel, or SRP with chlorhexidine gel. The study will evaluate changes in probing pocket depth, clinical attachment level, gingival index, plaque index, and gingival crevicular fluid tumor necrosis factor alpha levels at baseline and follow-up visits to compare the effects of the three treatment approaches.

Conditions: Stage II Grade B Periodontitis
Being tested: Placebo gel (Methyle cellulose), Active oxygen gel, Chlorhexidine gel
Keywords: Periodontitis, Active oxygen gel, Chlorhexidine gel, Scaling and root planing, Gingival crevicular fluid, Local drug delivery, TNF-alpha.
Medical subject headings: Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo gel (Methyle cellulose)Drug
Methyle cellulose placebo gel administered subgingivally as adjunct to scaling and root planing
Active oxygen gelDrug
active oxygen gel administered subgingivally as adjunct to scaling and root planing
Chlorhexidine gelDrug
Chlorhexidine gel administered subgingivaly as adjunct to scaling and root planing

Study groups in NCT07840716
Study group	Role	What they receive
Group A - SRP plus placebo gel	Placebo comparator	Scaling and root planing followed by locally delivered placebo gel ( Methyl Cellulose Gel) Receives: Drug: Placebo gel (Methyle cellulose)
Group B - SRP plus Active oxygen gel	Experimental	Scaling and root planing followed by locally delivered active oxygen gel Receives: Drug: Active oxygen gel
Group C - SRP plus chlorhexidine gel	Active comparator	Scaling and root planing followed by locally delivered chlorhexidine gel Receives: Drug: Chlorhexidine gel

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical attachment level
Clinical attachment level (CAL) will be measured in millimeters using UNC-15 periodontal probe from cementoenamel junction (CEJ) to the base of the pocket at baseline, 1, 3, and 6 months post-treatment.
Measured: Baseline, 1,3, and 6 months
Tumor necrosis factor alpha (TNF-alpha)
Tumor necrosis factor alpha levels in gingival crevicular fluid will be measured pg/ml using enzyme-linked immunosorbent assay (ELISA)
Measured: Baseline, 1, and 3 months.

Secondary outcomes (3)

Probing pocket depth (PPD)
Probing pocket depth (PPD) will be measured in millimeters using UNC-15 periodontal probe assessed at baseline, 1, 3, and 6 months.
Measured: Baseline, 1, 3, and 6 months
Gingival index (GI)
Gingival index (GI) will be assessed using the Silness and Löe Gingival Index at baseline 1, 3, and 6 months post-treatment
Measured: Baseline, 1, 3, and 6 months.
Plaque index (PI)
Plaque index will be assessed using the Silness and Löe plaque index at baseline, 1, 3, and 6 months post-treatment.
Measured: Baseline, 1, 3, and 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 2026Aug 2027

First posted25 Sep 2026
Study start30 Sep 2026 (estimated)
Primary completionJul 2027 (estimated)
Study completionAug 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Stage II Grade B PeriodontitisStudies of the same condition, open and under way.
More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
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: Single blind
Who is masked: Participant
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07840716
Sponsor's protocol ID: AOG-CHX-PERIO-RCT-2026
Status last verified: Jul 2026
First submitted: 19 Sep 2026
Last updated: 25 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.
PubMed 5237684
Afacan B, Ozturk VO, Pasali C, Bozkurt E, Kose T, Emingil G. Gingival crevicular fluid and salivary HIF-1alpha, VEGF, and TNF-alpha levels in periodontal health and disease. J Periodontol. 2019 Jul;90(7):788-797. doi: 10.1002/JPER.18-0412. Epub 2018 Dec 11.
PubMed 30536725
Kollmar T, Schepers M, Nogueira AVB, Deschner J, Muller-Heupt LK. Oxygen-Based Adjunct Therapies in Periodontitis: A Systematic Review and Meta-Analysis Within the Framework of Hypoxia and Inflammation. Biomedicines. 2025 Dec 19;14(1):9. doi: 10.3390/biomedicines14010009.
PubMed 41595546
Finnegan M, Linley E, Denyer SP, McDonnell G, Simons C, Maillard JY. Mode of action of hydrogen peroxide and other oxidizing agents: differences between liquid and gas forms. J Antimicrob Chemother. 2010 Oct;65(10):2108-15. doi: 10.1093/jac/dkq308. Epub 2010 Aug 16.
PubMed 20713407
Brookes ZLS, Bescos R, Belfield LA, Ali K, Roberts A. Current uses of chlorhexidine for management of oral disease: a narrative review. J Dent. 2020 Dec;103:103497. doi: 10.1016/j.jdent.2020.103497. Epub 2020 Oct 17.
PubMed 33075450
Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.
PubMed 32383274
Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.
PubMed 29926952
Hajishengallis G, Chavakis T. Local and systemic mechanisms linking periodontal disease and inflammatory comorbidities. Nat Rev Immunol. 2021 Jul;21(7):426-440. doi: 10.1038/s41577-020-00488-6. Epub 2021 Jan 28.
PubMed 33510490
Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721.
PubMed 29926951

Interested in taking part?

Sara Malik

+201505610567

Sara_pg03@den.kfs.edu.eg

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Stage II Grade B Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Efficacy of Active Oxygen Gel Versus Chlorhexidine Gel as an Adjunct to Subgingival Instrumentation in the Treatment of Stage II Grade B Periodontitis: A Randomized Controlled Clinical Trial With Biomarkers Assessment.
ClinicalTrials.gov ID: NCT07840716
Acronym / sponsor ID: AOG-CHX-PERIO-RCT-2026
Conditions: Stage II Grade B Periodontitis
Keywords: Periodontitis, Active oxygen gel, Chlorhexidine gel, Scaling and root planing, Gingival crevicular fluid, Local drug delivery, TNF-alpha.
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: Kafrelsheikh UniversityUniversity, hospital or other
Study start: 30 Sep 2026 (estimated)
Primary completion: Jul 2027 (estimated)
Study completion: Aug 2027 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Group A - SRP plus placebo gel	Placebo comparator	Drug: Placebo gel (Methyle cellulose)Scaling and root planing followed by locally delivered placebo gel ( Methyl Cellulose Gel)
Group B - SRP plus Active oxygen gel	Experimental	Drug: Active oxygen gelScaling and root planing followed by locally delivered active oxygen gel
Group C - SRP plus chlorhexidine gel	Active comparator	Drug: Chlorhexidine gelScaling and root planing followed by locally delivered chlorhexidine gel

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Adults aged 18-50 years.
Patients with stage II grade B periodontitis
Probing pocket. Depth less or equal to 5mm, CAL = 3 to 4mm in selected sites.
Good general health without systemic conditions affecting periodontal health.

Key exclusion criteria (5 listed)

Smoking.
Pregnancy or lactating.
Allergy to chlorhexidine.
Patients under antibiotics or anti-inflammatory drugs within the past 3 months.
Previous periodontal therapy within the past 6 months.

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
Placebo gel (Methyle cellulose)Methyle cellulose placebo gel administered subgingivally as adjunct to scaling and root planing	Drug	Group A - SRP plus placebo gel
Active oxygen gelactive oxygen gel administered subgingivally as adjunct to scaling and root planing	Drug	Group B - SRP plus Active oxygen gel
Chlorhexidine gelChlorhexidine gel administered subgingivaly as adjunct to scaling and root planing	Drug	Group C - SRP plus chlorhexidine gel

Primary outcome

Clinical attachment level
Time frame: Baseline, 1,3, and 6 months
Clinical attachment level (CAL) will be measured in millimeters using UNC-15 periodontal probe from cementoenamel junction (CEJ) to the base of the pocket at baseline, 1, 3, and 6 months post-treatment.
Tumor necrosis factor alpha (TNF-alpha)
Time frame: Baseline, 1, and 3 months.
Tumor necrosis factor alpha levels in gingival crevicular fluid will be measured pg/ml using enzyme-linked immunosorbent assay (ELISA)

3 secondary outcomes

Probing pocket depth (PPD)
Time frame: Baseline, 1, 3, and 6 months
Gingival index (GI)
Time frame: Baseline, 1, 3, and 6 months.
Plaque index (PI)
Time frame: Baseline, 1, 3, and 6 months.

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 25 Sep 2026.
Background: PubMed 5237684Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.
Background: PubMed 30536725Afacan B, Ozturk VO, Pasali C, Bozkurt E, Kose T, Emingil G. Gingival crevicular fluid and salivary HIF-1alpha, VEGF, and TNF-alpha levels in periodontal health and disease. J Periodontol. 2019 Jul;90(7):788-797. doi: 10.1002/JPER.18-0412. Epub 2018 Dec 11.
Background: PubMed 41595546Kollmar T, Schepers M, Nogueira AVB, Deschner J, Muller-Heupt LK. Oxygen-Based Adjunct Therapies in Periodontitis: A Systematic Review and Meta-Analysis Within the Framework of Hypoxia and Inflammation. Biomedicines. 2025 Dec 19;14(1):9. doi: 10.3390/biomedicines14010009.
Background: PubMed 20713407Finnegan M, Linley E, Denyer SP, McDonnell G, Simons C, Maillard JY. Mode of action of hydrogen peroxide and other oxidizing agents: differences between liquid and gas forms. J Antimicrob Chemother. 2010 Oct;65(10):2108-15. doi: 10.1093/jac/dkq308. Epub 2010 Aug 16.
Background: PubMed 33075450Brookes ZLS, Bescos R, Belfield LA, Ali K, Roberts A. Current uses of chlorhexidine for management of oral disease: a narrative review. J Dent. 2020 Dec;103:103497. doi: 10.1016/j.jdent.2020.103497. Epub 2020 Oct 17.
Background: PubMed 32383274Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.
Background: PubMed 29926952Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.
Background: PubMed 33510490Hajishengallis G, Chavakis T. Local and systemic mechanisms linking periodontal disease and inflammatory comorbidities. Nat Rev Immunol. 2021 Jul;21(7):426-440. doi: 10.1038/s41577-020-00488-6. Epub 2021 Jan 28.
Background: PubMed 29926951Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721.

Related trials for Stage II Grade B Periodontitis

Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
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Not yet recruiting
Spirulina Gel in the Treatment of Periodontitis
Periodontitis, Periodontitis Stage II
Not yet recruiting
Locally Delivered Melatonin Gel in Management of Stage II Grade B Periodontitis
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Clinical & Biochemical Evaluation of Antioxidant Vs. Chlorhexidine as an Adjunctive to Non-Surgical Treatment of Stage II-grade B Periodontitis
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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.

Sara Malik contact

+201505610567

Sara_pg03@den.kfs.edu.eg

Enas Elgendy contact

+20473109548

enas_ahmed@den.kfs.edu.eg

Questions about this trial

What is this clinical trial studying?

A study testing Active oxygen gel and Chlorhexidine gel in people with Stage II Grade B Periodontitis, run by Kafrelsheikh University.

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 4 inclusion and 5 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Sara Malik (+201505610567, Sara_pg03@den.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical attachment level (time frame: Baseline, 1,3, and 6 months). 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?

On the ClinicalTrials.gov record for NCT07840716, which also lists 9 linked publications.

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 25 Sep 2026.