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

Primary Purpose

Gingival Diseases

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Gotukola
Scaling
Sponsored by
Sri Hasanamba Dental College and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Diseases focused on measuring antiplaque, antigingivitis

Eligibility Criteria

14 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Talat Mohammadi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

group 1

group 2

group 3

Arm Description

scaling and Gotukola mouthwash intervention- 1.Scaling 2.Gotukola mouthwash , 10ml twice daily to be rinsed for 60 seconds

Scaling

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 13, 2016
Last Updated
July 7, 2016
Sponsor
Sri Hasanamba Dental College and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02827305
Brief Title
Centella Asiatica (Gotukola) Mouthwash as an Adjunct to Mechanical Plaque Control
Official Title
Clinical Evaluation of the Centella Asiatica (Gotukola) Mouthwash as an Adjunct to Mechanical Plaque Control: A RCT
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sri Hasanamba Dental College and Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Diseases
Keywords
antiplaque, antigingivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Experimental
Arm Description
scaling and Gotukola mouthwash intervention- 1.Scaling 2.Gotukola mouthwash , 10ml twice daily to be rinsed for 60 seconds
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
Scaling
Arm Title
group 3
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gotukola
Other Intervention Name(s)
Centella Asiatica
Intervention Description
10 ml of mouthwash to be rinsed for duration of 60 seconds
Intervention Type
Procedure
Intervention Name(s)
Scaling
Intervention Description
Ultrasonic scaling was performed in one visit on both upper and lower arches.
Primary Outcome Measure Information:
Title
The efficacy of gotukola as an adjunct to scaling was assessed by using plaque index and gingival indes
Description
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
Time Frame
2-8-2015 to 16-8-2015

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Talat Mohammadi, PG student
Organizational Affiliation
Sri Hasanamba Dental College and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Talat Mohammadi
City
Hassan
State/Province
Karnataka
ZIP/Postal Code
573201
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
14604059
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.
Results Reference
background
PubMed Identifier
16022023
Citation
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.
Results Reference
background

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

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