| 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
|
|
|
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
|
|
|
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. |