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

Gingival Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02827305
• Other study ID #: SHDCH/2015-16/1409
• Status: Completed
• Phase: Phase 1
• First received: May 13, 2016
• Last updated: July 7, 2016
• Start date: August 2015
• Est. completion date: August 2015

Study information

• Verified date: July 2016
• Source: Sri Hasanamba Dental College and Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 30 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Diseases

Intervention

Drug:
• Gotukola
10 ml of mouthwash to be rinsed for duration of 60 seconds

Procedure:
• Scaling
Ultrasonic scaling was performed in one visit on both upper and lower arches.

Locations

Country	Name	City	State
India	Talat Mohammadi	Hassan	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Sri Hasanamba Dental College and Hospital

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes