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

Sponsor
Sri Hasanamba Dental College and Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02827305
Collaborator
(none)
36
Enrollment
1
Location
3
Arms

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of the Centella Asiatica (Gotukola) Mouthwash as an Adjunct to Mechanical Plaque Control: A RCT
Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
Aug 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Talat Mohammadi Hassan Karnataka India 573201

    Sponsors and Collaborators

    • Sri Hasanamba Dental College and Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Talat Mohammadi, Post graduate student, Sri Hasanamba Dental College and Hospital
    ClinicalTrials.gov Identifier:
    NCT02827305
    Other Study ID Numbers:
    • SHDCH/2015-16/1409
    First Posted:
    Jul 11, 2016
    Last Update Posted:
    Jul 11, 2016
    Last Verified:
    Jul 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Talat Mohammadi, Post graduate student, Sri Hasanamba Dental College and Hospital
    antiplaque
    antigingivitis
    Additional relevant MeSH terms:
    Gingival Diseases

    Study Results

    No Results Posted as of Jul 11, 2016