Comparative Evaluation Of The Efficacy Of Sub Gingivally Delivered T. Arjuna Bark Gel As An Adjunct To Scaling And Root Planing Versus Scaling And Root Planing Alone In Individuals With Periodontitis – A Randomized Controlled Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- To evaluate the clinical efficacy of sub-gingivally
Study Overview
Brief Summary
This is a randomized clinical split mouth study to evaluate the clinical efficacy of sub gingivally T. Arjuna bark gel as an adjunct to scaling and root planing in patients with periodontitis. Study desig :Randomized Split mouth study .Group 1 consisting of 25 subjects with periodontitis, having 4mm- 6mm pocket depth receiving T. Arjuna bark gel as a local drug delivery and Group 2 consisting of 25 subjects with periodontitis having 4mm- 6mm pocket depth undergoing only scaling and root planing. The clinical parameters [ plaque index, gingival index, relative attachment loss, probing pocket depth] will be evaluated at baseline, one month and three month period. The data obtained will be entered in Microsoft excel spread sheet and will be further analyzed with the help of SPSS software ( version 17.0, IBM.USA)
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •.Both male and female patients with 4mm.
- •6mm pocket depth in at least 2 teeth in contralateral quadrants.2.Age group between 18-60 years with good systemic health.
- •Minimum 20 teeth should be present in the mouth of patients. 4.Patients with no history of allergies.
Exclusion Criteria
- •1.Patients suffering from any known systemic diseases.2.Smokers and alcoholic patients.3 Pregnancy or lactating female patients.4.Patients who have received surgical or nonsurgical periodontal therapy in last 3 months prior to the baseline visit.
Outcomes
Primary Outcomes
To evaluate the clinical efficacy of sub-gingivally
Time Frame: Baseline | One month after local drug delivery | Three month after local drug delivery
randomised controlled trial.
Time Frame: Baseline | One month after local drug delivery | Three month after local drug delivery
delivered T. Arjuna bark gel as an adjunct to non-surgical periodontal therapy in patients with periodontitis having 4mm - 6mm pocket depth: a split mouth randomized study
Time Frame: Baseline | One month after local drug delivery | Three month after local drug delivery
Secondary Outcomes
- To evaluate improvement in plaque index,(gingival index,probing)