Comparison of two mouth rinses (Triphala and Listerine) in patients undergoing fixed orthodontic therapy

ISRCTN	ISRCTN76770396
DOI	https://doi.org/10.1186/ISRCTN76770396
Secondary identifying numbers	004

Submission date: 04/04/2018
Registration date: 19/04/2018
Last edited: 18/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Roshni Nair
Scientific

Department of Periodontics
Amrita School of Dentistry
AIMS Cochin
Cochin
682041
India

Phone	+91 (0)9845866696
Email	dr.roshninair@yahoo.in

Study information

Study design	Interventional single-centre single-blind parallel study
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Comparing efficacy of 0.6% Triphala with Listerine mouth rinse on gingival health during fixed orthodontic therapy
Study objectives	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(s)	Thesis Protocol Review Committee (Scientific, Ethical, Financial), 15/03/2016, ref/004/TPRC/2016
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	12/09/2015
Completion date	04/11/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	30 Years
Sex	Both
Target number of participants	Two groups with 17 patients each
Key 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)
Key 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
Date of first enrolment	20/06/2016
Date of final enrolment	03/10/2017

Locations

Countries of recruitment

India

Study participating centre

Amrita School of Dentistry, Amrita Vishwavidyapeetham

Cochin
682041
India

Sponsor information

Amrita School of Dentistry
University/education

Amrita Institute of Medical Science and Research Centre
Cochin
682041
India

"ROR"	https://ror.org/03am10p12

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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 plan	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).