Condition category
Oral Health
Date applied
04/04/2018
Date assigned
19/04/2018
Last edited
18/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of this study is to assess the effect of 0.6% Triphala mouth rinse as compared to Listerine on gingival (gum) health in patients undergoing fixed orthodontic (brace) treatment.

Who can participate?
Patients aged 18-30 undergoing fixed orthodontic treatment with signs of gum inflammation

What does the study involve?
Participants are randomly allocated into two groups to use either 0.6% Triphala or Listerine mouth rinse twice daily. Both groups are assessed for gum inflammation, plaque and oral hygiene after 7, 14 and 30 days.

What are the possible benefits and risks of participating?
Using Listerine may reduce gum inflammation and plaque build-up. Possible risks include allergy or mild burning sensation due to the alcohol content. Triphala is a herbal product, widely used in Ayurvedic practice. In this study it is used as an oral rinse at a very low concentration and the risks associated with it are with overdose of a systemically administered form.

Where is the study run from?
Amrita School of Dentistry, Amrita Vishwavidyapeetham (India)

When is the study starting and how long is it expected to run for?
September 2015 to November 2017

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Roshni Nair
dr.roshninair@yahoo.in

Trial website

Contact information

Type

Scientific

Primary contact

Dr Roshni Nair

ORCID ID

Contact details

Department of Periodontics
Amrita School of Dentistry
AIMS Cochin
Cochin
682041
India
+91 (0)9845866696
dr.roshninair@yahoo.in

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

004

Study information

Scientific title

Comparing efficacy of 0.6% Triphala with Listerine mouth rinse on gingival health during fixed orthodontic therapy

Acronym

Study hypothesis

To assess the effect of 0.6% Triphala mouth rinse as compared to Listerine on gingival health in patients undergoing fixed orthodontic therapy at an interval of 7 days, 14 days and 30 days.

Ethics approval

Thesis Protocol Review Committee (Scientific, Ethical, Financial), 15/03/2016, ref/004/TPRC/2016

Study design

Interventional single-centre single-blind parallel study

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Gingival inflammation and associated enlargement, plaque commonly seen in patients undergoing fixed orthodontic treatment

Intervention

Patients were assigned to one of two groups by block randomization, single blind masking:
1. Reference arm: Listerine mouth rinse
2. Active arm: 0.6% Triphala mouth rinse

Both groups are assessed on clinical parameters (baseline assessment: gingival status, plaque score and oral hygiene score) followed by removal of existing dental hard and soft deposits by supragingival scaling. Patients in each group get the respective mouth rinse and rinse twice daily with 20 ml of the prescribed mouth rinse. Reassessment of the clinical parameters is carried out at 7, 14 and 30 days. Total duration of treatment 30 days.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Gum inflammation and associated gingival enlargement, assessed using Modified Gingival Index and Seymour Gingival Enlargement Index at baseline, 7, 14 and 30 days

Secondary outcome measures

Plaque build up and oral hygiene status, assessed using Plaque Index and Simplified Oral Hygiene Index at baseline, 7, 14 and 30 days

Overall trial start date

12/09/2015

Overall trial end date

04/11/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18-30 years
2. Minimum of 20 teeth
3. Patients undergoing fixed orthodontic therapy with initial teeth alignment completed
4. Good general health - absence of any systemic illness
5. Gingival enlargement grade 1 or 2 (bokenkamp)
6. Gingival index above 2 (Modified Gingival Index by Lobene)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Two groups with 17 patients each

Participant exclusion criteria

1. Known hypersensitivity to the mouth rinses under study
2. Active periodontitis
3. Hard and soft tissue tumours
4. Oral red and white lesions
5. Antibiotic therapy in past 30 days
6. Use of mouthwash in the last 3 months
7. Medications with an effect on oral tissues
8. Habits: smoking, tobacco/paan chewing

Recruitment start date

20/06/2016

Recruitment end date

03/10/2017

Locations

Countries of recruitment

India

Trial participating centre

Amrita School of Dentistry, Amrita Vishwavidyapeetham
Cochin
682041
India

Sponsor information

Organisation

Amrita School of Dentistry

Sponsor details

Amrita Institute of Medical Science and Research Centre
Cochin
682041
India

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Study protocol can be available on request. Planned publication of the results in a high impact peer reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Roshni Nair (dr.roshninair@yahoo.in).

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes