Comparison of two mouth rinses (Triphala and Listerine) in patients undergoing fixed orthodontic therapy
| ISRCTN | ISRCTN76770396 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76770396 |
| Protocol serial number | 004 |
| Sponsor | Amrita School of Dentistry |
| Funder | Investigator initiated and funded |
- 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
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
Scientific
Department of Periodontics
Amrita School of Dentistry
AIMS Cochin
Cochin
682041
India
| Phone | +91 (0)9845866696 |
|---|---|
| dr.roshninair@yahoo.in |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional single-centre single-blind parallel study |
| Secondary study design | Randomised parallel trial |
| Study type | Participant 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(s) |
Gum inflammation and associated gingival enlargement, assessed using Modified Gingival Index and Seymour Gingival Enlargement Index at baseline, 7, 14 and 30 days |
| Key secondary outcome measure(s) |
Plaque build up and oral hygiene status, assessed using Plaque Index and Simplified Oral Hygiene Index at baseline, 7, 14 and 30 days |
| Completion date | 04/11/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 30 Years |
| Sex | All |
| Target sample size at registration | 34 |
| 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
682041
India
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
