Evaluation of Clinical and Anti-Inflammatory efficacy of Berberine HCI Containing Mouth wash on Dental Plaque Induced Gingivitis
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- The Berberine HCl containing mouthwash has a significant anti-inflammatory and anti-plaque effect on the clinical
Overview
Brief Summary
The study titled “Evaluation of Clinical and Anti-Inflammatory Efficacy of Berberine HCl Containing Mouthwash on Plaque-Induced Gingivitis” aims to assess the potential of Berberine HCl mouthwash as a natural alternative to chlorhexidine in managing plaque-induced gingivitis. Ninety-three patients with gingivitis will be divided into three groups using Berberine HCl mouthwash, 0.2% chlorhexidine, or saline rinse for 15 days. Clinical parameters—Full Mouth Plaque Score (FMPS), Full Mouth Bleeding Score (FMBS)—and salivary levels of interleukin-4 (IL-4) and interleukin-6 (IL-6) will be evaluated at baseline, day 15, and day 21. Statistical analysis will compare the anti-plaque and anti-inflammatory effects among the groups. The study is expected to demonstrate that Berberine mouthwash offers comparable or superior clinical and biochemical benefits to chlorhexidine, making it an effective, herbal, and side effect–free alternative for gingivitis management.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •18-40 years of age
- •Patients with moderate to severe gingivitis with a minimum of 20 permanent with gingival inflammation.
- •No previous history of periodontal surgery or consumption of antibiotics/anti-inflammatory medications in the past 6 months.
- •Systemically healthy.
Exclusion Criteria
- •Patients suffering from systemic diseases, which may have an impact on the periodontium, such as diabetes mellitus and osteoporosis.
- •Uncooperative patients.
- •Patients on antibiotics and/or anti-inflammatory drugs.
- •Patients with a history of drug allergy or hypersensitivity reactions.
Outcomes
Primary Outcomes
The Berberine HCl containing mouthwash has a significant anti-inflammatory and anti-plaque effect on the clinical
Time Frame: Baseline, day 7, day 15, day 21
signs and biochemical levels of dental plaque-induced gingival inflammation.
Time Frame: Baseline, day 7, day 15, day 21
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Bhaskarya Bhaskar Bora
AB Shetty Dental College