NCT02827305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

Same day

First QC Date

May 13, 2016

Last Update Submit

July 7, 2016

Conditions

Gingival Diseases

Keywords

antiplaqueantigingivitis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

group 1

EXPERIMENTAL

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

Drug: GotukolaProcedure: Scaling

group 2

ACTIVE COMPARATOR

Scaling

Procedure: Scaling

group 3

ACTIVE COMPARATOR

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

Interventions

GotukolaDRUG

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

Also known as: Centella Asiatica
group 1group 3
ScalingPROCEDURE

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

group 1group 2

Eligibility Criteria

Age14 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Minimum of 22 natural teeth
  • Participants with Chronic generalized gingivitis
  • Participants with plaque index score ≥1

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Talat Mohammadi

Hassan, Karnataka, 573201, India

Location

Related Publications (2)

  • 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.

    PMID: 14604059BACKGROUND

  • 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.

    PMID: 16022023BACKGROUND

MeSH Terms

Conditions

Gingival Diseases

Interventions

Centella asiatica extractTooth Exfoliation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Talat Mohammadi, PG student

    Sri Hasanamba Dental College and Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post graduate student

Study Record Dates

First Submitted

May 13, 2016

First Posted

July 11, 2016

Study Start

August 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

July 11, 2016

Record last verified: 2016-07

Locations

IN(1)