| CTRI Number |
CTRI/2025/06/089140 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Chewing Sticks vs. Toothbrushes: Which Cleans Better? |
|
Scientific Title of Study
|
The Battle For Oral Health - A Randomized Clinical Trial comparing Chewing Sticks and Toothbrushes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonal Subhangi |
| Designation |
PG 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 |
9123145990 |
| Fax |
|
| Email |
drsonalsubhangi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradeep Tangade |
| Designation |
Principal and Professor |
| 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 |
09997466339 |
| Fax |
|
| Email |
pradeeptangade02@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pradeep Tangade |
| Designation |
Principal and Professor |
| 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 |
09997466339 |
| Fax |
|
| Email |
pradeeptangade02@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sonal Subhangi |
| Address |
Teerthanker Mahaveer University, Delhi Road, NH-09, Mordabad , Uttar Pradesh |
| 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 |
| Sonal Subhangi |
Teerthanker Mahaveer Dental College and Research Centre |
Department of Public Health Dentistry, Teerthanker Mahaveer Dental College and Research Centre, Teerthanker Mahaveer University, Moradabad, Uttar Pradesh
Moradabad
UTTAR PRADESH |
9123145990
drsonalsubhangi@gmail.com |
|
|
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 |
| Healthy Human Volunteers |
Regularly attending dental students at Teerthanker Mahaveer Dental College and Research Centre.
Age range between 18 and 22 years.
Willingness to participate and provide written informed consent |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Participants using manual toothbrushes (considered standard oral hygiene method). |
Participants in the control group were provided with a standard manual toothbrush, which is considered the conventional method for maintaining oral hygiene. |
| Intervention |
Participants using Neem chewing sticks |
Participants assigned to the intervention group were provided with Neem (Azadirachta indica) chewing sticks as a traditional oral hygiene aid. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
22.00 Year(s) |
| Gender |
Both |
| Details |
Regularly attending dental students at Teerthanker Mahaveer Dental College and Research Centre.
Age range between 18 and 22 years.
Willingness to participate and provide written informed consent after being informed about the study’s purpose and benefits. |
|
| ExclusionCriteria |
| Details |
systemic or oral illnesses, dental prostheses use, manual dexterity impairment, recent or ongoing antibiotic consumption, and refusal to participate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy in reducing dental plaque levels
Measured using a standardized plaque index (e.g., Silness and Löe Plaque Index) after the intervention period. |
Efficacy in reducing dental plaque levels
Measured using a standardized Baseline (Day 0)
End of Study (Day 28 / 1 month) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gingival health status
Assessed by gingival index scores (e.g., Löe and Silness Gingival Index) to evaluate inflammation and bleeding.
Oral hygiene compliance and acceptability
Participant-reported ease of use, satisfaction, and adherence to the assigned oral hygiene method.
Changes in oral microbial load (if applicable)
Quantitative assessment of oral bacteria reduction following the intervention.
Any adverse effects related to the use of chewing sticks or manual toothbrushes
For example, gum irritation, sensitivity, or other oral mucosal changes. |
Baseline (Day 0)
End of Study (Day 28 / 1 month)
Throughout study (weekly or daily logs)
Final feedback at end of study
Monitored continuously during the study
Final evaluation at end of study
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/06/2025 |
| 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="1"
Days="0" |
|
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 randomized controlled trial aims to compare the efficacy of Neem chewing sticks and manual toothbrushes in reducing dental plaque and improving gingival health over a one-month period. The study involves dental students aged 18–22 years from a private dental college. Participants are randomly allocated into two groups, with one group using manual toothbrushes and the other using Neem chewing sticks. Plaque and gingival indices are assessed at baseline and after one month by calibrated examiners. The study follows guidelines from the American Dental Association for sample size determination and employs appropriate statistical methods for data analysis. |