| CTRI Number |
CTRI/2024/11/077024 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Foam tooth brush on oral health status. |
|
Scientific Title of Study
|
Effectiveness of foam tooth brush on oral health status of children with Attention Deficit Hyperactivity Disorder - A 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 |
Yazhini Selvaraj |
| Designation |
Postgraduate student |
| Affiliation |
KSR Institute of Dental Science and Research |
| Address |
Department of Pediatric and Preventive Dentistry,
KSR Institute of Dental Science and Research,
KSR Kalvi nagar,Thokkavadi.
Namakkal
TAMIL NADU
637215
India |
| Phone |
08610738184 |
| Fax |
|
| Email |
dr.yazhselva@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.GeethaPriya PR |
| Designation |
Professor and Head |
| Affiliation |
KSR Institute of Dental Science and Research |
| Address |
Department of Pediatric and Preventive Dentistry,
KSR Institute of Dental Science and Research,
KSR Kalvi nagar,Thokkavadi.
Namakkal
TAMIL NADU
637215
India |
| Phone |
08610738184 |
| Fax |
|
| Email |
drgppedo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yazhini Selvaraj |
| Designation |
Postgraduate student |
| Affiliation |
KSR Institute of Dental Science and Research |
| Address |
Department of Pediatric and Preventive Dentistry,
KSR Institute of Dental Science and Research,
KSR Kalvi nagar,Thokkavadi.
TAMIL NADU
637215
India |
| Phone |
08610738184 |
| Fax |
|
| Email |
dr.yazhselva@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry,KSR Institute of Dental Science and Research, KSR Kalvi nagar, Tiruchengode,Namakkal,Tamil Nadu, India-637215. |
|
|
Primary Sponsor
|
| Name |
The Tamilnadu Dr.MGR Medical University |
| Address |
No.69,Anna salai, Guindy,Chennai-600032. |
| Type of Sponsor |
Other [Medical University] |
|
|
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 Yazhini Selvaraj |
PI: Yazhini Selvaraj KSR Institute of Dental Science and Research |
Department of Pediatric and Preventive Dentistry (Department number 5),
KSR Institute of Dental Science and Research,
KSR kalvi Nagar,
Thokkavadi,
Tiruchengode,
Namakkal,
Tamil nadu,
India-637215.
Namakkal
TAMIL NADU |
08610738184
dr.yazhselva@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KSRIDSR Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers will be screened |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
colgate soft tooth brush |
colgate soft tooth brush brushing twice daily for 3 months |
| Intervention |
Colgate ultrafoam tooth brush |
Foam tooth brush for duration of 3 months with twice brushing daily. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children and their parents who were able to read and respond to a questionnaire. |
|
| ExclusionCriteria |
| Details |
Children with systemic illness, other medical conditions and parents who could not read and respond to a questionnaire will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of foam tooth brush and conventional tooth brush on oral health status of children with ADHD. |
Baseline, 15 days, 1 month, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the toothbrush wear of foam tooth brush and conventional tooth brush on oral health status of children with ADHD. |
Baseline, 15 days, 1 month, 3 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
29/11/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
sent for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
NULL HYPOTHESIS There is no difference between the effectiveness of foam toothbrush and conventional toothbrush on oral health status of children with ADHD. Method: Oral prophylaxis will be done and oral health education will be given to the children with ADHD one week before the intervention. Baseline Visual Plaque Index (VPI) scores (Silness and Loe, 1967), and Gingival Bleeding Index (GBI) scores (Loe and Silness, 1963) will be recorded in four tooth surfaces (buccal / facial, lingual, mesio-buccal, disto-buccal surfaces) of all teeth using mouth mirror and explorer two days after the oral prophylaxis. Disclosing agent (Alpha Plac) will be used before the examination. Children will be divided into 2 subtypes - Attention-deficit as group 1 and Hyperactive and Impulsivity as group 2 based on parents response for ADHD rating score. Each subtype will be further randomly allocated into two subgroups. Subgroup 1 will be given conventional toothbrushes (Colgate soft tooth brush) and subgroup 2 will be given foam toothbrushes (Colgate ultrafoam ultrasoft toothbrush). A specific fluoridated toothpaste will be provided to all the children, to use during the three month study period. Proper brushing instructions and IDA approved toothpastes (Colgate) will be given to the children. Post-intervention data (VPI, GBI scores) will be recorded after 15 days, 1 month and 3 months and wear assessment of the toothbrush will be done after 3months and data will be statistical analyzed.
|