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Not yet recruitingNCT07840716Updated Sep 25, 2026

Active Oxygen Gel vs Chlorhexidine Gel in Stage II Grade B Periodontitis

An interventional study of Placebo gel (Methyle cellulose) and Active oxygen gel in Stage II Grade B Periodontitis, sponsored by Kafrelsheikh University. Not yet recruiting. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Treatment

Updated Sep 25, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Stage II Grade B Periodontitis

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Keywords

  • Periodontitis, Active oxygen gel, Chlorhexidine gel, Scaling and root planing, Gingival crevicular fluid, Local drug delivery, TNF-alpha.
03

In context

Periodontitis

1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.

This study's planned enrollment of 60 is above the median of 44 across 846 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Kafrelsheikh University is the lead sponsor of 294 studies on the registry; 114 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
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

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Placebo comparator
    Group A - SRP plus placebo gel

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

    Drug: Placebo gel (Methyle cellulose)

  • Experimental
    Group B - SRP plus Active oxygen gel

    Scaling and root planing followed by locally delivered active oxygen gel

    Drug: Active oxygen gel

  • Active comparator
    Group C - SRP plus chlorhexidine gel

    Scaling and root planing followed by locally delivered chlorhexidine gel

    Drug: Chlorhexidine gel

Interventions

  • DrugPlacebo gel (Methyle cellulose)

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

  • DrugActive oxygen gel

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

  • Chlorhexidine gel administered subgingivaly as adjunct to scaling and root planing

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 1,3, and 6 months

  2. 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)

    Time frame: Baseline, 1, and 3 months.

Secondary outcomes

  1. 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.

    Time frame: Baseline, 1, 3, and 6 months

  2. 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

    Time frame: Baseline, 1, 3, and 6 months.

  3. Plaque index (PI)

    Plaque index will be assessed using the Silness and Löe plaque index at baseline, 1, 3, and 6 months post-treatment.

    Time frame: Baseline, 1, 3, and 6 months.

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗
09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Sep 25, 2026
Show all 1 update
  1. 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 ↗

10

Registry details

Key details

Study ID
NCT07840716
Responsible party
Sara Adam Abdalla Malik (Postgraduate Researcher, Department of Periodontology, Faculty of Dentistry, Kafrelsheikh University, Kafrelsheikh University) — Principal investigator
First posted
Sep 25, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Sara Malik
Contact
Sara_pg03@den.kfs.edu.eg
+201505610567
Enas Elgendy
Contact
enas_ahmed@den.kfs.edu.eg
+20473109548

Oversight

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

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