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CTRI Number  CTRI/2026/03/105793 [Registered on: 10/03/2026] Trial Registered Prospectively
Last Modified On: 09/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Improving Oral Hygiene in Children with Cerebral Palsy Using Wrist Exercises and Oral Health Education 
Scientific Title of Study   Effectiveness of wrist activation exercises and oral health education among individuals with Cerebral Palsy: 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 Sharmila Arockia Mary S 
Designation  Postgraduate 2 year  
Affiliation  Indira Gandhi Institute of Dental Sciences  
Address  Department of Public Health Dentistry Indira Gandhi Institute of Dental Sciences Sri Balaji Vidyapeeth Deemed to be University Pondicherry Campus Pillayarkuppam Puducherry 607402 India

Pondicherry
PONDICHERRY
607402
India 
Phone  6369443140  
Fax    
Email  spsharmila30@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sharmila Arockia Mary S 
Designation  Postgraduate 2 year  
Affiliation  Indira Gandhi Institute of Dental Sciences  
Address  Department of Public Health Dentistry Indira Gandhi Institute of Dental Sciences Sri Balaji Vidyapeeth Deemed to be University Pondicherry Campus Pillayarkuppam Puducherry 607402 India

Pondicherry
PONDICHERRY
607402
India 
Phone  6369443140  
Fax    
Email  spsharmila30@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Senthil M  
Designation  Professor 
Affiliation  Indira Gandhi Institute of Dental Sciences  
Address  Department of Public Health Dentistry Indira Gandhi Institute of Dental Sciences Sri Balaji Vidyapeeth Deemed to be University Pondicherry Campus Pillayarkuppam Puducherry 607402 India

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 Sharmila Arockia Mary S 
Address  Indira Gandhi Institute of Dental Sciences, SBV Pondicherry campus, Pillayarkuppam, Pondicherry- 607402  
Type of Sponsor  Other [] 
 
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 
Kannan  Satya Special School  6, 7, 8 ECR Road Karuvadikuppam, Pondicherry - 605008
Pondicherry
PONDICHERRY 		 9047232707

kannan@satyaspecialschool.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indira Gandhi Institute of Dental Scineces  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Oral Health Education Alone  Participants in Group B will receive structured oral health education alone for a total duration of 12 weeks, including demonstration of appropriate toothbrushing technique, instruction on fluoridated toothpaste use, and caregiver reinforcement. No wrist activation exercises will be provided. Follow up assessments will be conducted at 1 week, 4 weeks, 8 weeks, and 12 weeks. 
Intervention  Wrist Activation Exercises along with Oral Health Education  Participants in Group B will receive structured oral health education alone for a total duration of 12 weeks, including demonstration of appropriate toothbrushing technique, instruction on fluoridated toothpaste use, and caregiver reinforcement. No wrist activation exercises will be provided. Follow up assessments will be conducted at 1 week, 4 weeks, 8 weeks, and 12 weeks. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Individuals diagnosed with spastic cerebral palsy.

Age between 6 to 15 years.

Classified under Manual Ability Classification System (MACS) Levels II and III:

Level II – Handles most objects with reduced quality or speed.

Level III – Handles objects with difficulty; requires assistance to prepare or modify activities.

Classified under Modified Ashworth Scale (MAS) Grade 1 and Grade 1+:

Grade 1 – Slight increase in muscle tone with minimal resistance at end range of motion.

Grade 1+ – Slight increase in muscle tone with minimal resistance through less than half of range of motion.

Able to understand and respond to simple commands, either independently or with caregiver assistance 
 
ExclusionCriteria 
Details  Individuals with severe cognitive impairment preventing understanding or response to simple commands, even with caregiver assistance.

Individuals who have undergone orthopedic surgery or received botulinum toxin (Botox) injection within the past 6 months.

Individuals with additional disabilities such as hearing or visual impairment.

Individuals with systemic illnesses such as epilepsy. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in Oral Hygiene Index-Simplified (OHI-S) and Modified Gingival Index (MGI) scores   3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Change in wrist flexion and extension range of motion measured using a goniometer  3 months 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   30/03/2026 
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)   Not Yet Recruiting 
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  

Cerebral palsy is a neurodevelopmental disorder characterized by impaired motor function and poor manual dexterity which affects the ability to maintain oral hygiene. Children with cerebral palsy are at higher risk of dental diseases due to difficulty in performing effective tooth brushing. This randomized controlled trial aims to evaluate the effectiveness of wrist activation exercises combined with oral health education in improving oral hygiene among individuals with spastic cerebral palsy aged 6 to 15 years. Eligible participants will be randomly allocated into two groups. The intervention group will receive supervised wrist activation exercises along with structured oral health education for 12 weeks. The control group will receive oral health education alone. Oral hygiene status will be assessed using Oral Hygiene Index Simplified and Modified Gingival Index. Wrist range of motion will be measured using a goniometer. Assessments will be done at baseline and at 1 week 4 weeks 8 weeks and 12 weeks. The study aims to determine whether wrist activation exercises improve hand coordination and thereby enhance oral hygiene in children with cerebral palsy.

 
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