| CTRI Number |
CTRI/2025/06/089279 [Registered on: 20/06/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparing Different Methods to Keep Childrens Teeth Dry During Dental Fillings |
|
Scientific Title of Study
|
Evaluating and comparing efficacy of various isolation techniques during proximal restorations of children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrunali Deshkar |
| Designation |
Postgraduate student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Pediatric and Preventive Dentistry,third floor SPDC buiding , Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9403173738 |
| Fax |
|
| Email |
mrunalideshkar123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nilima Thosar |
| Designation |
Professor and head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Pediatric and Preventive Dentistry,third floor SPDC buiding , Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9284522620 |
| Fax |
|
| Email |
drnthosar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nilima Thosar |
| Designation |
Professor and head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Pediatric and Preventive Dentistry,third floor SPDC buiding , Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9284522620 |
| Fax |
|
| Email |
drnthosar@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research , Sawangi ,Wardha , 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research, Wardha , India 442001 |
| Address |
Sawangi Meghe, Wardha , India , 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Mrunali Deshkar |
Sharad Pawar Dental College and Hospital |
Department of Pediatric and Preventive Dentistry,third floor SPDC buiding , Sawangi
Wardha
MAHARASHTRA |
9403173738
mrunalideshkar123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
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 |
| Comparator Agent |
Conventional rubber dam |
This study is based on comparison of conventional rubberdam with that of minidam and optra dam of children with age group of 6 to 8 years with proximal caries |
| Intervention |
Optra dam, Mini dam |
this intervention involves patients of age group 6 to 8 years with proximal restoration and will be conducted for duration of 6 months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children age between 6 to 8 years.
Patients who have more than one proximal carious lesion that needs simple restoration
Patients who required multiple appointments.
|
|
| ExclusionCriteria |
| Details |
Patients who were unwilling to be part of the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is the effectiveness of the mini dam in keeping teeth dry during cavity fillings in children. |
Assesement would be carried out at the end of 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome is the comfort and ease of use of the OptraDam for both the child and the clinician during cavity fillings. |
Assesment would be carried out at the end of 3 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
04/07/2025 |
| 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="6"
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
|
Background-This clinical study evaluates and compares the effectiveness of different isolation techniques during proximal restorations in pediatric patients. Proper isolation is crucial to maintain a dry field, ensuring the quality and durability of dental restorations. The study focuses on methods like the mini dam, OptraDam, and traditional rubber dams, assessing their ability to prevent moisture contamination, ease of use, and comfort for young patients Material and Methods-The present study will be carried
out in the Department of Pediatric and Preventive Dentistry of Sharad Pawar
Dental College, Sawangi (Meghe), Wardha. Inclusion criteria includes children age between 6 to
8 years, patients who have more
than one proximal carious lesion that needs simple restoration, patients who required
multiple appointments. Exclusion criteria involves patients who were
unwilling to be part of the study. Conclusion-This study could investigate potential improvements in dental
isolation methods to further reduce anxiety and improve overall patient
experience.
|