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

ConditionStage II Grade B Periodontitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorKafrelsheikh University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Smoking.

Pregnancy or lactating.

Allergy to chlorhexidine.

Patients under antibiotics or anti-inflammatory drugs within the past 3 months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Group A - SRP plus placebo gelPlacebo comparator 1 intervention
Group B: Group B - SRP plus Active oxygen gelExperimental treatment 1 intervention
Group C: Group C - SRP plus chlorhexidine gelActive comparator 1 intervention

Trial outcomes

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kafrelsheikh University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: