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

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ClinicalTrials.gov Identifier: NCT02827305
Recruitment Status : Completed
First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Talat Mohammadi, 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.

Condition or disease Intervention/treatment Phase
Gingival Diseases Drug: Gotukola Procedure: Scaling 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 Type : Interventional  (Clinical Trial)
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 : August 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gum Disease

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 Name: 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 Name: Centella Asiatica




Primary Outcome Measures :
  1. The efficacy of gotukola as an adjunct to scaling was assessed by using plaque index and gingival indes [ Time Frame: 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



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Ages Eligible for Study:   14 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02827305


Locations
India
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

Publications:
Responsible Party: Talat Mohammadi, Post graduate student, Sri Hasanamba Dental College and Hospital
ClinicalTrials.gov Identifier: NCT02827305     History of Changes
Other Study ID Numbers: SHDCH/2015-16/1409
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Talat Mohammadi, Sri Hasanamba Dental College and Hospital:
antiplaque
antigingivitis

Additional relevant MeSH terms:
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases