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Completed

NCT Number: NCT02827305

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

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.

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Key information

Conditions

Gingival Diseases Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

14 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Talat Mohammadi

Hassan, Karnataka, 573201, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gotukola

Drug

10 ml of mouthwash to be rinsed for duration of 60 seconds

Other names: Centella Asiatica

Scaling

Procedure

Ultrasonic scaling was performed in one visit on both upper and lower arches.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sri Hasanamba Dental College and Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 11, 2016
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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