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CTRI Number  CTRI/2025/08/092926 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On: 12/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the efficiency and patient perception towards Conventional rubber dam and Insta dam for dental fillings of lower primary mandibular molars: A Randomized clinical trial  
Scientific Title of Study   Comparative evaluation of the efficiency and patient perception towards conventional rubber dam and Insta dam for restoration of primary mandibular molars: A randomized clinical 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  SEJAL KATARIYA 
Designation  Post graduate student 
Affiliation  Pacific dental college and hospital, Debari 
Address  Department of pediatric and preventive dentistry, Pacific dental college and hospital, Debari, Udaipur

Udaipur
RAJASTHAN
313024
India 
Phone  9359589922  
Fax    
Email  katariyasejal07@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dinesh Rao 
Designation  HOD pg guide 
Affiliation  Pacific dental college and hospital, Debari 
Address  Department of pediatric and preventive dentistry, Pacific dental college and hospital, Debari, Udaipur RAJASTHAN 313024 INDIA

Udaipur
RAJASTHAN
313024
India 
Phone  9414158235  
Fax    
Email  pedodinesh2003@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dinesh Rao 
Designation  HOD pg guide 
Affiliation  Pacific dental college and hospital, Debari 
Address  Department of pediatric and preventive dentistry, Pacific dental college and hospital, Debari, Udaipur INDIA

Udaipur
RAJASTHAN
313024
India 
Phone  9414158235  
Fax    
Email  pedodinesh2003@yahoo.co.in  
 
Source of Monetary or Material Support  
Pacific Dental College And Hospital, Debari, Udaipur 313204 
 
Primary Sponsor  
Name  Sejal Katariya 
Address  Pacific Dental college and hospital, Debari, Udaipur 313024 
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 SEJAL KATARIYA  Pacific Dental College And Hospital Debari Udaipur 313024  Department of pediatric and preventive dentistry first floor room number nine Pacific Dental College And Hospital Debari Udaipur 313024 Udaipur RAJASTHAN
Udaipur
RAJASTHAN 
9359589922

katariyasejal07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethic Committee Sai Tirupati University Udaipur Rajasthan India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Conventional rubber dam   Class 1 restoration of primary mandibular molars under conventional rubber dam isolation and evaluation of outcome measures will be done at baseline 
Comparator Agent  Insta dam  Class 1 restoration of primary mandibular molars under Insta dam isolation and evaluation of outcome measures will be done at baseline  
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children who require Class 1 restoration in primary mandibular molar
Fully erupted primary mandibular molar
Simplified Oral Hygiene Index score of 0.5
Frankl’s behaviour ratings 3 and 4
 
 
ExclusionCriteria 
Details  Molars with any developmental anomalies
Previously restored teeth
Tooth where isolation is not possible
Any clinical or radiographic evidence of proximal caries, periapical and periodontal pathology
Special health-care needs
Not willing
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Time of placement   Evaluation will be done at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Isolation efficiency  Evaluation will be done at baseline 
Gingival health  Evaluation will be done at baseline 
Anxiety levels  Evaluation will be done at baseline 
 
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   Phase 4 
Date of First Enrollment (India)   24/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  24/08/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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  

The oral cavity is a complex environment surrounded by hard and soft tissues. Most dental materials are hydrophobic, making moisture control essential for successful treatment. Challenges such as saliva, microorganisms, and limited control of the patient’s tongue and soft tissues make isolation difficult. Effective isolation improves treatment quality, safety, and longevity, while also preventing aspiration or ingestion of foreign objects. Rubber dam isolation was first introduced by Dr. Sanford Christie Barnum in 1869. Although its use declined in the early 20th century due to alternative methods and evolving dental practices, it remains a widely accepted and efficient isolation technique today, offering better visibility, moisture control, and a sterile field. Pediatric patients pose unique challenges for isolation due to limited cooperation. Common techniques include rubber dams, cotton rolls, saliva ejectors, gauze, and throat shields. While rubber dams are effective, traditional metal clamps can cause discomfort, soft-tissue injury, and anxiety in children. 

So, a newer advancement known as Insta dam is there.

Insta-Dam is a frameless, foldable rubber dam that eliminates the need for a traditional frame. It offers full isolation with just a single hole punch, is more comfortable, reduces gag reflex, allows easy X-rays, and improves workflow. It enhances infection control, reduces microleakage, supports shade matching, and improves treatment outcomes.

Despite these advantages, limited research has focused on patient comfort, cooperation, and clinical efficiency of Insta-Dam in pediatric dentistry. Therefore, the current study aims to compare the efficiency and patient perception of Insta-Dam with conventional rubber dams in restoring primary mandibular molars in children aged 7-10 years.


 
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