Comparisons of Efficacy of Triphala and Chlorhexidine Mouthwash Against Plaque Accumulation and Gingivitis. A Randomized Controlled Trail.
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bangladesh Medical University
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- PIaque Index
Overview
Brief Summary
Gingivitis is one of the commonly prevalent oral diseases worldwide which is caused by the bacterial biofilm adhering to the teeth surfaces. Chlorhexidine is the antimicrobial agent most familiar to dental professionals. The need for frequent application of Chlorhexidine and other side effects such as unpleasant taste and staining has stimulated the search for alternatives. "Triphala" is among the most common formulas used in Traditional Ayurvedic Medicine. Triphala has an antibacterial effect. In this context, a study was undertaken to ascertain the effects of a mouthwash prepared with Triphala on the oral health status and compare it with commercially available Chlorhexidine mouthwash.
Detailed Description
Dental plaque is the main cause of gingivitis and effective plaque control is essential for maintaining gingival health. Along with mechanical cleaning methods, mouthwashes are commonly used as adjunct therapy to reduce plaque accumulation and gingival inflammation. Chlorhexidine is considered the gold standard chemical plaque control agent but its long-term use is limited by side effects such as tooth staining and taste alteration. Triphala, a herbal formulation with known antimicrobial and anti-inflammatory properties has emerged as a potential alternative. Comparing the efficacy of triphala and chlorhexidine mouthwash against plaque accumulation and gingivitis may help to identify a safer and acceptable option for maintaining routine oral hygiene.
Aims and objectives:
To compare the efficacy of triphala and chlorhexidine mouth wash against plaque accumulation and gingivitis.
Materials and methods
A randomized controlled trial was conducted among 220 patients with chronic generalized gingivitis attending the Outpatient Department of Bangladesh medical University (BMU), Dhaka. Participants were randomly assigned using shuffled numbered cards to Group A (Triphala mouthwash, n = 110) and Group B (Chlorhexidine mouthwash, n = 110).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age groups of 18-45 years with
- •Mild to moderate gingivitis,
- •Patients with a minimum of 20 teeth, and
- •Patients who have not undergone periodontal treatment in the past 6 months.
Exclusion Criteria
- •Use of anti-inflammatory drugs and antibiotics in previous 6 months;
- •Individuals with prosthetic appliances or orthodontic appliances that would interfere with evaluation
- •Allergy to Triphala and Chlorhexidine used in the study;
- •Smokers or users of tobacco in any form
- •Lactating females or pregnant women
- •Mental-retarded patients.
Arms & Interventions
6% Triphala mouthwash
Experimental: 15ml of 6%Triphala mouthwash twice daily for 30 days.
Intervention: 6% Triphala mouthwash (Other)
placebo Comparator:Placebo Participants received 15 ml of 6% chlorhexidine mouthwash
placebo Participants received 15 ml mouthwash twice daily for 30 days
Intervention: .2% chlorhexidine mouthwash (Other)
Outcomes
Primary Outcomes
PIaque Index
Time Frame: 30 days
plaque index 0:no plaque is in the area adjacent to the gingiva plaque index 1:there is a plaque in the form of a thin film on the gingival margin plaque index 2:there is a visible plaque in the gingival pocket and gingival margin plaque index 3:there is a dense plaque in the gingival pocket and gingival margin
Gingival Index
Time Frame: 30 days
Gingival index 0: Healthy gums. Gingival index 1: Mild discolouration and oedematous gingiva. No bleeding on probing. Gingival index 2: Red, oedematous and shiny gingiva. There is bleeding on probing. Gingival index 3: Red, oedematous and ulcerated gingiva. There is spontaneous bleeding.
BIeeding Index
Time Frame: 30 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Dilruba Sarmin
Principal investigator
Bangladesh Medical University