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

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07840716
Enrollment
60
Registered
2026-09-25
Start date
2026-09-30
Completion date
2027-08-01
Last updated
2026-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

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.

Interventions

DRUGPlacebo gel (Methyle cellulose)

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

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

Chlorhexidine gel administered subgingivaly as adjunct to scaling and root planing

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical attachment levelBaseline, 1,3, and 6 monthsClinical 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)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

MeasureTime frameDescription
Probing pocket depth (PPD)Baseline, 1, 3, and 6 monthsProbing pocket depth (PPD) will be measured in millimeters using UNC-15 periodontal probe assessed at baseline, 1, 3, and 6 months.
Gingival index (GI)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
Plaque index (PI)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.

Contacts

CONTACTSara Malik
Sara_pg03@den.kfs.edu.eg+201505610567
CONTACTEnas Elgendy
enas_ahmed@den.kfs.edu.eg+20473109548

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 26, 2026