NCT07840716

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Sep 2026Aug 2027

First Submitted

Initial submission to the registry

September 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

September 30, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

September 25, 2026

Status Verified

July 1, 2026

Enrollment Period

9 months

First QC Date

September 19, 2026

Last Update Submit

September 19, 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.

Outcome Measures

Primary Outcomes (2)

  • 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.

    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)

    Baseline, 1, and 3 months.

Secondary Outcomes (3)

  • Probing pocket depth (PPD)

    Baseline, 1, 3, and 6 months

  • Gingival index (GI)

    Baseline, 1, 3, and 6 months.

  • Plaque index (PI)

    Baseline, 1, 3, and 6 months.

Study Arms (3)

Group A - SRP plus placebo gel

PLACEBO COMPARATOR

Scaling and root planing followed by locally delivered placebo gel ( Methyl Cellulose Gel)

Drug: Placebo gel (Methyle cellulose)

Group B - SRP plus Active oxygen gel

EXPERIMENTAL

Scaling and root planing followed by locally delivered active oxygen gel

Drug: Active oxygen gel

Group C - SRP plus chlorhexidine gel

ACTIVE COMPARATOR

Scaling and root planing followed by locally delivered chlorhexidine gel

Drug: Chlorhexidine gel

Interventions

Placebo gel (Methyle cellulose)DRUG

Methyle cellulose placebo gel administered subgingivally as adjunct to scaling and root planing

Group A - SRP plus placebo gel
Active oxygen gelDRUG

active oxygen gel administered subgingivally as adjunct to scaling and root planing

Group B - SRP plus Active oxygen gel
Chlorhexidine gelDRUG

Chlorhexidine gel administered subgingivaly as adjunct to scaling and root planing

Group C - SRP plus chlorhexidine gel

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 5237684BACKGROUND

  • 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.

    PMID: 30536725BACKGROUND

  • 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.

    PMID: 41595546BACKGROUND

  • 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.

    PMID: 20713407BACKGROUND

  • 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.

    PMID: 33075450BACKGROUND

  • 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.

    PMID: 32383274BACKGROUND

  • 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.

    PMID: 29926952BACKGROUND

  • 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.

    PMID: 33510490BACKGROUND

  • 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.

    PMID: 29926951BACKGROUND

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Sara Malik

CONTACT

+201505610567Sara_pg03@den.kfs.edu.eg

Enas Elgendy

CONTACT

+20473109548enas_ahmed@den.kfs.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate Researcher, Department of Periodontology, Faculty of Dentistry, Kafrelsheikh University

Study Record Dates

First Submitted

September 19, 2026

First Posted

September 25, 2026

Study Start

September 30, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

September 25, 2026

Record last verified: 2026-07