| CTRI Number |
CTRI/2025/06/088919 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Study on Mouthwashes for Reducing Bad Breath in Engineering Students |
|
Scientific Title of Study
|
Comparative Evaluation of Polyherbal and Chlorhexidine Mouthwashes on Oral Malodour in Engineering Students – A Crossover Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swayam Sourav Tripathy |
| Designation |
MDS Student |
| Affiliation |
Teerthanker Mahaveer Dental College and Research Centre |
| Address |
Department of Public Health Dentistry,
Teerthanker Mahaveer Dental College and Research Centre,
Teerthanker Mahaveer University,
Moradabad,
Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8249363780 |
| Fax |
|
| Email |
swayamsouravtripathy95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Singh |
| Designation |
Professor and Guide |
| Affiliation |
Teerthanker Mahaveer Dental College and Research Centre |
| Address |
Department of Public Health Dentistry,
Teerthanker Mahaveer Dental College and Research Centre,
Teerthanker Mahaveer University,
Moradabad,
Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9410095005 |
| Fax |
|
| Email |
drvikas.dental@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas Singh |
| Designation |
Professor and Guide |
| Affiliation |
Teerthanker Mahaveer Dental College and Research Centre |
| Address |
Department of Public Health Dentistry,
Teerthanker Mahaveer Dental College and Research Centre,
Teerthanker Mahaveer University,
Moradabad,
Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9410095005 |
| Fax |
|
| Email |
drvikas.dental@tmu.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Swayam Sourav Tripathy |
| Address |
Room no 809, Department of Public Health Dentistry,
Teerthanker Mahaveer Dental College and Research Centre,
Teerthanker Mahaveer University,
Delhi Road,
Moradabad,
Uttar Pradesh - 244001, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shambhu Bharadwaj |
Teerthanker Mahaveer College of Engineering |
Department of Computer Science Engineering, Room No LT-2,
Teerthanker Mahaveer University,
Delhi Road, Moradabad – 244001, Uttar Pradesh, India
Moradabad
UTTAR PRADESH |
7088782000
shambhu.computers@tmu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Teerthanker Mahaveer Dental College and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine gluconate mouthwash, Placebo mouthwash (dyed normal saline), Polyherbal mouthwash |
Each intervention (Polyherbal, Chlorhexidine 0.12%, and Placebo - dyed normal saline) will serve as comparator in the crossover design. 15 ml of mouthwash will be used twice daily for 14 days, with a 14-day washout period between phases. |
| Intervention |
Polyherbal mouthwash, Chlorhexidine gluconate mouthwash, Placebo mouthwash |
All participants will use 15 ml of each mouthwash (Polyherbal, 0.12% Chlorhexidine gluconate, and Placebo – dyed normal saline) twice daily for 14 days during each intervention period, with a 14-day washout period between phases, in a crossover randomized controlled trial. Mouthwashes will be used as per instructed rinsing protocol. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Engineering students of both genders between the age group of 18 and 25 years, who are studying in Teeerthanker Mahaveer College of Engineering, present on the evaluation day and are consenting and willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Those who do not study in the Teerthanker Mahaveer College of Engineering, and those refuse to participate in the study, or are outside the desired age group of 18 to 25 years. Students with underlying Systemic Diseases or severe underlying Dental Diseases. The Students who are undergoing Dental Treatment, including any ongoing orthodontic treatment will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in oral malodour level measured by organoleptic scoring method with the help of Rosenberg & Mcculloch Scale. |
Outcome measures will be assessed at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks and at 10 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in plaque levels (Turesky-Gilmore-Glickman Modification of the Quigley-Hein Index) |
Day 0 and Day 14 of each intervention period |
| Change in tongue coating (Winkel Tongue Coating Index) |
Day 0 and Day 14 of each intervention period |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a single-centre, randomized, single-blind, crossover controlled trial evaluating the oral hygiene efficacy of a polyherbal mouthwash in comparison to 0.12% chlorhexidine gluconate mouthwash and dyed normal saline (placebo) in reducing oral halitosis. The study will be conducted over a period of 10 weeks among 30 engineering students aged 18 to 25 years from the College of Engineering, Teerthanker Mahaveer University. The primary outcome is the change in oral malodour levels, assessed using the Organoleptic Scoring Method based on the Rosenberg and McCulloch scale. Secondary outcomes include changes in plaque levels measured by the Turesky-Gilmore-Glickman modification of the Quigley-Hein Plaque Index, and tongue coating assessed using the Winkel Tongue Coating Index. |