| CTRI Number |
CTRI/2022/04/042279 [Registered on: 28/04/2022] Trial Registered Prospectively |
| Last Modified On: |
30/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF BRUSHING EFFICACY BETWEEN NYLON AND CHARCOAL BRISTLES TOOTHBRUSHES IN CHILDREN |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF PLAQUE REMOVAL EFFICACY AND QUANTITATIVE ANALYSIS OF STREPTOCOCCUS MUTANS IN SALIVA AFTER USING NYLON AND CHARCOAL BRISTLES TOOTHBRUSHES IN CHILDREN – A CLINICO-MICROBIOLOGICAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr ANKITA ANNU |
| Designation |
PG STUDENT |
| Affiliation |
BHARATI VIDYAPEETH DENTAL COLLEGE AND HOSPITAL SANGLI |
| Address |
DEPARTMENT OF PEDIATRIC & PREVENTIVE DENTISTRY
BHARATI VIDYAPEETH DENTAL COLLEGE AND HOSPITAL
BHARATI VIDYAPEETH DEEMED TO BE UNIVERSITY
SANGLI
BHARATI VIDYAPEETH DEEMED TO BE UNIVERSITY
SANGLI PIN 416416
Sangli
MAHARASHTRA
416416
India |
| Phone |
8456978447 |
| Fax |
|
| Email |
annu1479@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SUJATHA P |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
BHARATI VIDYAPEETH DENTAL COLLEGE AND HOSPITAL SANGLI |
| Address |
DEPARTMENT OF PEDIATRIC & PREVENTIVE DENTISTRY
BHARATI VIDYAPEETH DENTAL COLLEGE AND HOSPITAL
BHARATI VIDYAPEETH DEEMED TO BE UNIVERSITY
SANGLI
BHARATI VIDYAPEETH DEEMED TO BE UNIVERSITY
SANGLI PIN 416416
Sangli
MAHARASHTRA
416416
India |
| Phone |
8618557518 |
| Fax |
|
| Email |
drsuji912@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANKITA ANNU |
| Designation |
PG STUDENT |
| Affiliation |
BHARATI VIDYAPEETH DENTAL COLLEGE AND HOSPITAL SANGLI |
| Address |
DEPARTMENT OF PEDIATRIC & PREVENTIVE DENTISTRY
BHARATI VIDYAPEETH DENTAL COLLEGE AND HOSPITAL
BHARATI VIDYAPEETH DEEMED TO BE UNIVERSITY
SANGLI
BHARATI VIDYAPEETH DEEMED TO BE UNIVERSITY
SANGLI PIN 416416
Sangli
MAHARASHTRA
416416
India |
| Phone |
8456978447 |
| Fax |
|
| Email |
annu1479@gmail.com |
|
|
Source of Monetary or Material Support
|
| BHARATI VIDYAPEETH DENTAL COLLEGE AND HOSPITAL, SANGLI |
|
|
Primary Sponsor
|
| Name |
Dr ANKITA ANNU |
| Address |
BHARATI VIDYAPEETH DENTAL COLLEGE AND HOSPITAL
BHARATI VIDYAPEETH DEEMED TO BE UNIVERSITY
SANGLI |
| Type of Sponsor |
Other [INDIVIDUAL PRINCIPAL INVESTIGATOR] |
|
|
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 ANKITA ANNU |
BHARATI VIDYAPEETH DENTAL COLLEGE & HOSPITAL |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, BHARATI VIDYEPEETH (DEEMED TO BE UNIVERSITY), SANGLI 416416
Sangli
MAHARASHTRA |
8456978447
annu1479@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, BHARATI VIDYAPEETH (DEEMED TO BE UNIVERSITY) MEDICAL COLLEGE AND HOSPITAL, SANGLI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
DENTAL CARIES |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CHARCOAL TOOTHBRUSH |
2 times in a day for 3 minutes each for 7 days.
|
| Intervention |
not applicable |
not applicable |
| Comparator Agent |
NYLON TOOTH BRUSH |
2 times in a day for 3 minutes each for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children with dmft and deft score less than 5 |
|
| ExclusionCriteria |
| Details |
Children with any systemic disorder.
Physically handicapped and mentally retarded children.
Children on medication.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| LOE AND SILLNESS PLAQUE INDEX AND STREPTOCOCCUS MUTANS COUNT IN SALIVA |
1 WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| LOE AND SILLNESS PLAQUE INDEX AND STREPTOCOCCUS MUTANS COUNT IN SALIVA |
AT BASELINE AND 3 DAYS |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2022 |
| Date of Study Completion (India) |
18/10/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized, parallel group, clinico-microbiological study comparing the plaque removal efficacy and effect on Streptococcus mutans count of charcoal and nylon bristles toothbrushes in children after regular brushing for a period of 1 week. |