Centella Asiatica (Gotukola) Mouthwash as an Adjunct to Mechanical Plaque Control

Phase 1

Completed

• Conditions: Gingival Diseases
• Interventions: Drug: Gotukola; Procedure: Scaling

• Registration Number: NCT02827305
• Lead Sponsor: Sri Hasanamba Dental College and Hospital

Brief Summary

This study evaluates the adjunctive use of Centella Asiatica (gotukola) to scaling in the reduction of plaque and gingival inflammation. Patients were divided into three groups of which group 1 received scaling and gotukola mouthwash, group 2 received scaling only and group 3 received gotukola mouthwash only.

Detailed Description

Mechanical plaque control by tooth brushing is considered to be the ideal way of preventing plaque associated gingivitis. However due to various factors individuals fail to perform an adequate quality of self performed plaque control. Centella Asiatica (gotukola) possess wide range of biological activities like anti-inflammatory, anti-psoriatic, anti-ulcer, hepato-protective, anticonvulsant, immunostimulant, cardioprotective, antidiabetic, antiviral, antibacterial, antifungal, etc. So, it could be used as adjunctive to mechanical periodontal therapy.

Study Timeline

• Study Start: 2015-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2016-05-13
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-07
• Last Update Submitted: 2016-07-07
• Study First Posted: 2016-07-11
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Minimum of 22 natural teeth
• Participants with Chronic generalized gingivitis
• Participants with plaque index score ≥1

Exclusion Criteria

• Participants with fixed or removable appliances
• Participants with more than full coverage restorations
• Medically compromised participants
• Participants on long term medications
• Smokers
• Participants who had used any type of antibacterial mouthwash in 4weeks of commencement.
• Patients with history of recent periodontal therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	Gotukola	scaling and Gotukola mouthwash intervention- 1.Scaling 2.Gotukola mouthwash , 10ml twice daily to be rinsed for 60 seconds
group 1	Scaling	scaling and Gotukola mouthwash intervention- 1.Scaling 2.Gotukola mouthwash , 10ml twice daily to be rinsed for 60 seconds
group 3	Gotukola	Intervention- Gotukola mouthwash only is advised to be used two times a day, each time 10ml rinsed for 60 seconds (morning and evening ) after the food.
group 2	Scaling	Scaling

Primary Outcome Measures

Name	Time	Method
The efficacy of gotukola as an adjunct to scaling was assessed by using plaque index and gingival indes	2-8-2015 to 16-8-2015	A total of 36 patients were participated in the study and the outcome measures were assessed 15 days after the start of the study, PLaque index ( Silnes and Loe 1964) - The buccal, lingual,mesial and distal surfaces of the index teeth is given a scoring from 0-3 The scores from the four areas of the teeth are added and divided by four in order to give the plaque index of the tooth. The index for the patient is obtained by summing the indices for all six teeth and dividing by six. Gingival index -Loe and Silnes 1963- The buccal, lingual,mesial and distal surfaces of all ginival tissues of index teeth were given a scroe from 0-3.This then constitutes the GI for the area and scores from the 4 areas of the tooth are added and divided by four to give GI for the tooth. Scores for individual teeth may be grouped to designate the GI for the group of the teeth. The scores are added and divided by nu,ber of teeth to get GI for an individual

Trial Locations

Locations (1)

Talat Mohammadi; 🇮🇳 Hassan, Karnataka, India