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NCT Number: NCT07840716

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

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.

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Key information

Conditions

Stage II Grade B Periodontitis Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Placebo gel (Methyle cellulose)

Drug

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

Active oxygen gel

Drug

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

chlorhexidine gel

Drug

Chlorhexidine gel administered subgingivaly as adjunct to scaling and root planing

Primary outcomes

  1. 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.

  2. 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)

Secondary outcomes

  1. Probing pocket depth (PPD)

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

    Probing pocket depth (PPD) will be measured in millimeters using UNC-15 periodontal probe assessed at baseline, 1, 3, and 6 months.

  2. Gingival index (GI)

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

    Gingival index (GI) will be assessed using the Silness and Löe Gingival Index at baseline 1, 3, and 6 months post-treatment

  3. Plaque index (PI)

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

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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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