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CTRI Number  CTRI/2026/02/103030 [Registered on: 04/02/2026] Trial Registered Prospectively
Last Modified On: 03/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of oral care on drooling and oral health status of children with cerebral palsy 
Scientific Title of Study   Effect of oral care on drooling and oral health status of children with cerebral palsy in selected hospital Kolkata 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Soma Sardar 
Designation  Post Graduate student 
Affiliation  NATIONAL INSTITUTE OF LOCOMOTOR DISABILITIES 
Address  department of rehabilitation nursing NATIONAL INSTITUTE OF LOCOMOTOR DISABILITIES BonHoogly
do
Kolkata
WEST BENGAL
700090
India 
Phone  7980153946  
Fax    
Email  somasardar915@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Subhra Srimani 
Designation  Lecturer cum ANS 
Affiliation  NATIONAL INSTITUTE OF LOCOMOTOR DISABILITIES 
Address  department of rehabilitation nursing NATIONAL INSTITUTE OF LOCOMOTOR DISABILITIES BonHoogly

Kolkata
WEST BENGAL
700090
India 
Phone  9474438611  
Fax    
Email  subhrasrimani2015@gmail.com  
 
Details of Contact Person
Public Query  
Name  Subhra Srimani 
Designation  Lecturer cum ANS 
Affiliation  NATIONAL INSTITUTE OF LOCOMOTOR DISABILITIES 
Address  department of rehabilitation nursing NATIONAL INSTITUTE OF LOCOMOTOR DISABILITIES BonHoogly

Kolkata
WEST BENGAL
700090
India 
Phone  9474438611  
Fax    
Email  subhrasrimani2015@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  National Institute for Locomotor Disabilities,(Divyangjan) 
Address  Bon-hooghly,kolkata-700090 
Type of Sponsor  Research institution and hospital 
 
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 Ameed Equebal  National Institute for Locomotor Disabilities  room no-103 cross disability early intervention center
Kolkata
WEST BENGAL 		 9474438611

subhrasrimani2015@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee of National Institute for Locomotor Disabilities Kolkata India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G809||Cerebral palsy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oral Care Intervention   Oral care in this study refers to a intervention package including tooth brushing, rinsing, and oral motor stimulation will be administered to children with cerebral palsy by the researcher. Their primary caregivers will be educated through step by step demonstration. Each child will receive the intervention individually for 20 minutes per session, three times a week for a duration of four weeks. Telephonic reminders will be sent to primary caregivers to ensure that oral care will be practiced at home on the remaining days of the week. 
Comparator Agent  Routine Care (Control Group)  Children in the control group will receive routine hospital care only, including their usual therapies and treatment without any structured oral care intervention. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  children Aged from 3years to 6years
Children with cerebral palsy (spastic, dyskinetic, ataxic, mixed) diagnosis will be confirmed from client file.
Both male and female.
Presenting with drooling
 
 
ExclusionCriteria 
Details  Children with other disabilities like autism spectrum disorders, other congenital deformities (cleft lip/ palate, ectodermal dysplasia).
Child on Ryle’s tube/ gastric tube
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Drooling by Thomas Stonell Greenberg Drooling Scale
Oral health status by Oral Health Assessment Tool 		 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in caregiver oral care practices.
reduction in perioral skin irritation due to drooling 		 4 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   16/02/2026 
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="1"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [subhrasrimani2015@gmail.com].

  6. For how long will this data be available start date provided 29-11-2028 and end date provided 29-11-2033?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This study aims to determine the effect of oral care on drooling and oral health status among children with cerebral palsy aged three to six years in a selected hospital in Kolkata. The study objectives are to assess drooling and oral health status before and after oral care and to evaluate the effectiveness of oral care in reducing drooling and improving oral health. Children aged three to six years diagnosed with cerebral palsy of any type and presenting with drooling will be included. Both male and female children whose primary caregivers give informed consent will participate. The study will follow a quantitative randomized pretest posttest control group design. Sixty children with cerebral palsy with drooling will be selected using simple random sampling and assigned into intervention and control groups with thirty participants in each group. Baseline assessment of drooling and oral health status will be done for both groups. The intervention group will receive a structured oral care intervention package including tooth brushing, rinsing and oral motor stimulation for four weeks. Each child will receive the intervention individually  twenty minutes three days a week. Telephonic reminders will be provided to primary caregivers to continue oral care at home. The control group will receive routine care only. After four weeks post intervention assessment of drooling and oral health status will be done. Drooling will be measured using the Thomas Stonell Greenberg Drooling Scale and oral health status will be measured using the Oral Health Assessment Tool to evaluate the effectiveness of the oral care intervention. 
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