| CTRI Number |
CTRI/2025/04/084556 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Different Manual Toothbrushes (Nylon,Neem and Charcoal) in PLaque Removal |
|
Scientific Title of Study
|
Plaque Removal Effectiveness Between Different Manual Toothbrushes With Nylon, Neem And Charcoal Infused Bristle Types : A Randomized Control 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 Rashim |
| Designation |
MDS 1st year Student |
| Affiliation |
Swami Devi Dyal Hospital and Dental college |
| Address |
Room no.5, 1st floor, Department of Public Health Dentistry, Swami Devi Dyal Hospital and Dental College, Barwala, Panchkula, Haryana
Panchkula
HARYANA
134118
India |
| Phone |
9991047463 |
| Fax |
258195 |
| Email |
rashimkant2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preety Gupta |
| Designation |
Professor |
| Affiliation |
Swami Devi Dyal Hospital and Dental College |
| Address |
Room no.5, 1st floor, Department of Public Health Dentistry, Swami Devi Dyal Hospital and Dental College, Barwala, Panchkula, Haryana
Panchkula
HARYANA
134118
India |
| Phone |
9876441194 |
| Fax |
258195 |
| Email |
dr.preety86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preety Gupta |
| Designation |
Professor |
| Affiliation |
Swami Devi Dyal Hospital and Dental College |
| Address |
Room no.5, 1st floor, Department of Public Health Dentistry, Swami Devi Dyal Hospital and Dental College, Barwala, Panchkula, Haryana
Panchkula
HARYANA
134118
India |
| Phone |
9876441194 |
| Fax |
258195 |
| Email |
dr.preety86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swami Devi Dyal Hospital and Dental College, Barwala, Panchkula, Haryana, 134118, India |
|
|
Primary Sponsor
|
| Name |
Dr Rashim |
| Address |
Swami Devi Dyal Hospital and Dental College, Barwala, Panchkula, Haryana, 134118, 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 Preety Gupta |
Swami Devi Dyal Hospital and Dental College, Barwala, Panchkula, Haryana, 134118, India |
Room no.5, 1st floor, Department of Public Health Dentistry
Panchkula
HARYANA |
9876441194
258195
dr.preety86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Swami Devi Dyal Hospital and Dental College, Golpura, Barwala, Panchkula, Haryana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Dental Students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Charcoal Infused Bristle Toothbrush, Neem Infused Bristle toothbrush. |
Colgate Zig-Zag Charcoal Infused Manual Toothbrush,
Colgate Zig-Zag Neem Infused Bristle Manual Toothbrush.
Intervention time period is 3 months |
| Comparator Agent |
Nylon Bristle Toothbrush |
Colgate Zig zag Nylon Bristle Toothbrush, Intervention time period is 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 to 25 years.
2. Participants with all fully erupted teeth.
3. No Underlying Systemic Condition.
4. Habit of brushing twice daily. |
|
| ExclusionCriteria |
| Details |
1.Participants with Gingival or Periodontal disease.
2. Who had received periodontal treatment in the past 6 months.
3. Wearing orthodontic or prosthetic appliance.
4. currently on antimicrobials.
5. Who reported tobacco use in any form
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Plaque removal efficacy of charcoal-infused, nylon, and neem-infused bristle manual toothbrushes. |
Baseline (day 0), 1st month, 2nd month, 3rd month (pre and post brushing) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of plaque removal effectiveness using Oral Hygiene Index-Simplified, Quigley-Hein Plaque Index, and Gingival index(Loe and Sillness) |
Baseline (day 0), 1st month, 2nd month, 3rd month (pre and post brushing) |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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)
|
30/04/2025 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 study at Swami Devi Dyal Hospital and Dental College will examine the PLAQUE REMOVAL EFFECTIVENESS of three toothbrush type ( nylon, charcoal - infused, and neem - infused) over three months with 135 participants (18-25 years of age).
Participants follow standard oral hygiene using Colgate Total 12 and the Modified Bass Technique while avoiding other aids.
Pre-brushing and post-brushing indices (OHI-S, PLAQUEINDEX, GINGIVAL INDEX) will be recorded at baseline, 1st, 2nd, and 3rd months.
Data analysis (SPSS) will determine the most effective toothbrush for oral hygiene. |