Stage II Grade B Periodontitis
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment level | 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Probing pocket depth (PPD) | 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. |
| 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. |