comparision of efficacy of punica granatum and citrus paradisi herbal extract mouthrinse with chlorhexidine gluconate mouth rinse in treatment of stage 1 periodontitis:a clinical and biochemical study
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To compare the efficacy of punica granatum and citrus paradisi herbal extract mouth rinse with chlorhexidine gluconate mouth rinse in stage one periodontitis
Study Overview
Brief Summary
Mouthwashes containing plant extracts which have no adverse effects are being used for their antiplaque and anti-inflammatory properties in the treatment of chronic gingivitis. Hence an attempt is being made to test and compare the efficacy of a combination herbal mouthwash with commercially available chlorhexidine mouthwash.
Material:
The formulation will be procured from Group Pharmaceuticals Pvt Lmt. Bengaluru. Biochemical analysis of saliva will be done is department of Biochemistry, JSS Medical College, Mysuru.
Study Design: This is a single blind clinical and biochemical study to compare the efficacy of a combination of punica granatum and citrus paradisi herbal mouth rinse with a currently marketed chlorhexidine mouth rinse in patients with stage 1 periodontitis.
Method:
Subjects who fulfil the inclusion criteria will be included in the study and will be randomly allocated to three treatment groups after scaling and oral hygiene instructions
Group A: Herbal Mouth Rinse containing punica granatum and citrus paradisi. Group B: 0.2 % Chlorhexidine Mouth rinse.
Group C: Scaling and root planing.
Clinical parameters to be recorded are:
Clinical parameters will be evaluated at the baseline, 15th and 30th day by a single calibrated examiner.
· Plaque index (Silness and Loe,1964)
· Sulcus bleeding index (Muhlemann-son)
· Probing Pocket Depth
· Clinical Attachment Level
The saliva samples will be collected at baseline and 30 days using a sterile Eppendorf tube and will be sent for biochemical analysis which will include measuring the total interleukin 1 β level in the sample.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 55.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.age:18-55 years
- •presenceof atleast 20 natural teeth
- •plaque and gingival index more than or equal to 1.5
- •probing depth not more than 4mm.
Exclusion Criteria
- •h/o periodontal treatment in last 6 months h/o antibiotic and anti inflammtory usage during 6 months h/o of known systemic disease that would alter the healing response of oraltissue smokers smoking or use of tobacoo in any form pregnant anf lactating women.
Outcomes
Primary Outcomes
To compare the efficacy of punica granatum and citrus paradisi herbal extract mouth rinse with chlorhexidine gluconate mouth rinse in stage one periodontitis
Time Frame: 30 days
Secondary Outcomes
- to asses the salivary Interleukin 1 beta levels(30 days)
Investigators
DrHarshithaC
JSS DENTAL COLLEGE AND HOSPITAL