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CTRI Number  CTRI/2024/07/070077 [Registered on: 05/07/2024] Trial Registered Prospectively
Last Modified On: 06/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Usefulness of customized toothbrush and commercial toothbrushes in improving oral hygiene among children with special needs 
Scientific Title of Study   Effectiveness of Indigenous customized toothbrush versus commercially available toothbrushes in improving oral hygiene among Intellectually disabled children – 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  Dr Roshni Maria Irwina A 
Designation  Postgraduate 
Affiliation  Indira Gandhi Institute of Dental Sciences 
Address  Department of Public Health Dentistry, Indira Gandhi Institute of Dental Sciences, SBV Pondicherry Campus, Pillayarkuppam, Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9597333226  
Fax    
Email  a.roshni.maria@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Senthil M 
Designation  Professor and Head 
Affiliation  Indira Gandhi Institute of Dental Sciences 
Address  Department of Public Health Dentistry, Indira Gandhi Institute of Dental Sciences, SBV Pondicherry Campus, Pillayarkuppam, Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9486365954  
Fax    
Email  senthilm@igids.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Senthil M 
Designation  Professor and Head 
Affiliation  Indira Gandhi Institute of Dental Sciences 
Address  Department of Public Health Dentistry, Indira Gandhi Institute of Dental Sciences, SBV Pondicherry Campus, Pillayarkuppam, Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9486365954  
Fax    
Email  senthilm@igids.ac.in  
 
Source of Monetary or Material Support  
Indira Gandhi Institute of Dental Sciences, SBV Pondicherry Campus, Pillayarkuppam, Pondicherry - 607402  
 
Primary Sponsor  
Name  Dr. Roshni Maria Irwina A 
Address  Indira Gandhi Institute of Dental Sciences, SBV Pondicherry Campus, Pillayarkuppam, Pondicherry - 607402 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Roshni Maria Irwina A  Satya Special School  6, 7 & 8, ECR Road, (Opp. to Siva Vishnu Mahal), Karuvadikuppam, Pondicherry - 605 008
Pondicherry
PONDICHERRY 		 9597333226

a.roshni.maria@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethical Committee  No Objection Certificate 
Institutional Ethical Committee, Indira Gandhi Institute of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F70||Mild intellectual disabilities, (2) ICD-10 Condition: F71||Moderate intellectual disabilities, (3) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Indigenous customized toothbrush  The children will be performing parent or caregiver assisted toothbrushing 2 times daily for 14 days and supervised toothbrushing for 3 months using indigenous customized toothbrush 
Comparator Agent  Manual toothbrush  The children will be performing parent or caregiver assisted toothbrushing 2 times daily for 14 days and supervised toothbrushing for 3 months using manual toothbrush 
Comparator Agent  Sonic powered toothbrush  The children will be performing parent or caregiver assisted toothbrushing 2 times daily for 14 days and supervised toothbrushing for 3 months using sonic powered toothbrush 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Study subjects aged 6 to 18 years in the mixed and permanent dentition
Study subjects having ID categorized as limit IQ as mild or moderate
Study subjects being part of psychosocial support groups under the supervision of a trained monitor
Study subjects with plaque induced gingivitis 
 
ExclusionCriteria 
Details  Subjects suffering from chronic debilitating conditions like Epilepsy Down syndrome etc and on long term medications which could influence their oral status
Subjects with history of receiving antibiotic and antiseptic therapy
Subjects with physical disabilities impaired motor functions non compliant behaviour etc
Subjects who are not willing to participate and did not give informed consent and assent
Patients with true periodontal pockets
Subjects undergoing fixed orthodontic therapy 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Effectiveness of indigenous customized toothbrush with commercially available toothbrushes among intellectually disabled children  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Effectiveness of indigenous customized toothbrush on TMQHPI scores and GI scores among intellectually disabled children  14 days, 1 month & 3 months 
Effectiveness of sonic powered toothbrush on TMQHPI scores and GI scores among intellectually disabled children  14 days, 1 month & 3 months 
Effectiveness of manual toothbrush on TMQHPI scores and GI scores among intellectually disabled children  14 days, 1 month & 3 months 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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
Modification(s)  		 Phase 2 
Date of First Enrollment (India)   31/07/2024 
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="6"
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   AIM: To compare the effectiveness of indigenous customized toothbrush with commercially available toothbrushes among intellectually disabled children.
RESEARCH QUESTION: Is there a difference in the effectiveness of indigenous customized toothbrush in comparison with commercially available toothbrushes among intellectually disabled children?
STUDY POPULATION: Intellectually disabled children inPuducherry and Cuddalore
SAMPLING PROCEDURE: The sampling method by which the study subjects would be selected is Cluster Sampling.
STUDY GROUPS:
Group A – (n=22) – Indigenous customized manual toothbrush (adult/junior)
Group B – (n=22) – Sonic Powered Toothbrush (adult/junior)
Group C – (n=22) – Manual Toothbrush (adult/junior)
SAMPLE SIZE: The sample size was calculated using G power software version 3.1. The calculation was based on the mean Plaque scores among children with cerebral palsy from a previous study. With 80% power and alpha error 5%, the minimum sample size was calculated to be 60, n=20 in each group. Anticipating a 10% loss to follow up, the sample size is calculated as 22 per group (n=22). Thus, the total sample size N=66
METHODOLOGY:
Before the experiment, each participant will undergo professional prophylaxis to ensure plaque-free status. At baseline, oral examination will be performed. Oral Examination: The plaque scores will be assessed using Turesky modification of the Quigley – Hein Plaque Index, 1970. Subjects will be asked to brush their teeth after examination to wash off the disclosing agent.The gingival scores will be assessed using Loe & Silness Gingival Index, 1963
Interventions for Group A, B, C:
Trial Phase: Assisted toothbrushing (0-14 days):
The study subjects will be advised to refrain from other oral hygiene practices except their allocated intervention during the study period. Respective toothbrushes and toothpastes will be provided to the caregivers/parents and proper toothbrushing technique (modified Bass technique) will be taught to both caregivers/parents/guardian and children through videos and typodont models. The children will be performing parent/caregiver-assisted toothbrushing 2 times daily for 14 days. The interventional compliance will be assessed by providing checklist pamphlets to caregivers/parents where they will record the date and time of the intervention for 3 months. 
15th -day visit: Subjects will be clinically evaluated with respect to Plaque and Gingival scores. Oral hygiene instructions will be reinforced.
Supervised toothbrushing (15 days -3 months):
1- month visit: Subjects will be clinically evaluated with respect to Plaque and Gingival scores. Oral hygiene instructions will be reinforced.
3- month visit: Subjects will be clinically evaluated with respect to Plaque and Gingival scores.
 
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