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CTRI Number  CTRI/2026/04/107534 [Registered on: 02/04/2026] Trial Registered Prospectively
Last Modified On: 01/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comfort of Cushioned Rubber Dam Clamps Compared with Regular Clamps in Children Aged 7–12 Years 
Scientific Title of Study   Assessment of customized cushioning of rubber dam clamps in comparison with conventional clamps among 7 to 12 year old children A randomized control 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  Vidya S 
Designation  Post Graduate Student 
Affiliation  SRM Kattankulathur Dental College 
Address  Room no. 109, Department of Pediatric And Preventive Dentistry, SRM Kattankulathur Dental College, Potheri, SRM Nagar, Kattankulathur, Tamil Nadu, 603203

Kancheepuram
TAMIL NADU
603203
India 
Phone  9840671897  
Fax    
Email  vidya30061@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kavitha Ramar 
Designation  Professor and Head Of Department of Pediatric And Preventive Dentistry  
Affiliation  SRM Kattankulathur Dental College 
Address  Room no. 109, Department of Pediatric And Preventive Dentistry, SRM Kattankulathur Dental College, Potheri, SRM Nagar, Kattankulathur, Tamil Nadu, 603203

Kancheepuram
TAMIL NADU
603203
India 
Phone  7401441335  
Fax    
Email  sv8429@srmist.edu.in  
 
Details of Contact Person
Public Query  
Name  Vidya S 
Designation  Post Graduate Student 
Affiliation  SRM Kattankulathur Dental College 
Address  Room no. 109, Department of Pediatric And Preventive Dentistry, SRM Kattankulathur Dental College, Potheri, SRM Nagar, Kattankulathur, Tamil Nadu, 603203

Kancheepuram
TAMIL NADU
603203
India 
Phone  9840671897  
Fax    
Email  vidya30061@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  S. Vidyashri 
Address  No. 61, 12th Avenue, Ashok Nagar, Chennai 83 
Type of Sponsor  Other [Self Funded] 
 
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 
Vidya S  SRM Kattankulathur Dental College  Room no. 109, Department of Pediatric And Preventive Dentistry, Potheri, SRM Nagar, Kattankulathur, Tamil Nadu, 603203
Kancheepuram
TAMIL NADU 		 9840671897

vidya30061@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College Hospital And Research Centre- Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Customized cushioning of rubber dam clamps using polyvinyl siloxane material  Polysiloxane material is placed on the jaws of the clamp and placed on the tooth. Class 1 restorative treatment is done after.  
Comparator Agent  Metal rubber dam clamps with no modifications  Metal rubber dam clamps are placed on the tooth with no modifications. Class 1 restorative treatment is done after.  
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children between the ages of 7 and 12 years who are in good general and physical health, whose child and parent are willing to participate in the study, presenting for their first dental visit, and having Class I caries involving only the enamel or enamel and dentin of the right and left primary mandibular posterior teeth will be included.
 
 
ExclusionCriteria 
Details  Children with the presence of orthodontic appliances, diagnosed mental or physical health issues, motor impairments, Class II or Class V caries, gingival issues including gingivitis, or latex allergy will be excluded from the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The efficacy of metal clamps with customized cushions and standard metal clamps will be assessed based on trauma to the gingival tissues, sealing ability of the clamp, slippage of the clamp, and pain perception of the patients.
 		 one week 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   15/04/2026 
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="2"
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 - 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 -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response -  Analytic Code

  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 - Data are available indefinitely at (Link to be included sv8429@srmist.edu.in).

  6. For how long will this data be available start date provided 01-04-2026 and end date provided 01-04-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Rubber dam isolation is the gold standard for moisture control during dental procedures, but the placement of conventional metal clamps in children can cause gingival trauma, pain, and slippage due to the anatomical features of primary teeth. Cushioning materials have been introduced to reduce direct metal contact with gingival tissues and improve patient comfort, though commercially available options are limited. Customized cushioning using polyvinyl siloxane material may provide a protective barrier, reduce tissue injury, and improve clamp stability. This randomized control trial aims to assess the effectiveness of customized cushioned rubber dam clamps compared with conventional metal clamps in children aged 7 to 12 years based on gingival trauma, sealing ability, clamp slippage, and patient pain perception.

 
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