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

Clinical Evaluation of the Centella Asiatica (Gotukola) Mouthwash as an Adjunct to Mechanical Plaque Control: A RCT

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.

Study Overview

• Status: Completed
• Conditions: Gingival Diseases
• Intervention / Treatment: Drug: Gotukola; Procedure: Scaling

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Hassan, Karnataka, India, 573201
      • Talat Mohammadi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1; scaling and Gotukola mouthwash intervention- 1.Scaling 2.Gotukola mouthwash , 10ml twice daily to be rinsed for 60 seconds	Drug: Gotukola; 10 ml of mouthwash to be rinsed for duration of 60 seconds; Other Names: Centella Asiatica; Procedure: Scaling; Ultrasonic scaling was performed in one visit on both upper and lower arches.
Active Comparator: group 2; Scaling	Procedure: Scaling; Ultrasonic scaling was performed in one visit on both upper and lower arches.
Active Comparator: group 3; 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.	Drug: Gotukola; 10 ml of mouthwash to be rinsed for duration of 60 seconds; Other Names: Centella Asiatica

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The efficacy of gotukola as an adjunct to scaling was assessed by using plaque index and gingival indes	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	2-8-2015 to 16-8-2015

Collaborators and Investigators

• Sponsor: Sri Hasanamba Dental College and Hospital
• Investigators: Principal Investigator: Talat Mohammadi, PG student, Sri Hasanamba Dental College and Hospital

Publications and helpful links

General Publications

• Sastravaha G, Yotnuengnit P, Booncong P, Sangtherapitikul P. Adjunctive periodontal treatment with Centella asiatica and Punica granatum extracts. A preliminary study. J Int Acad Periodontol. 2003 Oct;5(4):106-15.
• Sastravaha G, Gassmann G, Sangtherapitikul P, Grimm WD. Adjunctive periodontal treatment with Centella asiatica and Punica granatum extracts in supportive periodontal therapy. J Int Acad Periodontol. 2005 Jul;7(3):70-9.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: May 13, 2016
• First Submitted That Met QC Criteria: July 7, 2016
• First Posted (Estimate): July 11, 2016

Study Record Updates

• Last Update Posted (Estimate): July 11, 2016
• Last Update Submitted That Met QC Criteria: July 7, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: antiplaque; antigingivitis
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases
• Other Study ID Numbers: SHDCH/2015-16/1409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided