| CTRI Number |
CTRI/2025/02/081336 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comfort and acceptance of patients towards different isolation techniques in primary molars in children during silver diamine fluoride application |
|
Scientific Title of Study
|
Patient Comfort and Acceptance of Different Isolation Techniques for Silver Diamine Fluoride Application |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shirin Chavan |
| Designation |
third year post graduate student |
| Affiliation |
basement room no. zero department of pediatric and preventive dentistry, DY Patil school of dentistry sector 7 nerul navi mumbai Maharashtra 400706 india |
| Address |
basement room no. zero department of pediatric and preventive dentistry, DY Patil school of dentistry sector 7 nerul navi mumbai Maharashtra 400706 india
Mumbai
MAHARASHTRA
400706
India |
| Phone |
7030749055 |
| Fax |
|
| Email |
chavanshirin42@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa S Naik |
| Designation |
professor and head of department |
| Affiliation |
basement room no. zero department of pediatric and preventive dentistry, DY Patil school of dentistry sector 7 nerul navi mumbai Maharashtra 400706 india |
| Address |
basement room no. zero department of pediatric and preventive dentistry, DY Patil school of dentistry sector 7 nerul navi mumbai Maharashtra 400706 india
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9769600440 |
| Fax |
|
| Email |
shilpa.naik@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa S Naik |
| Designation |
professor and head of department |
| Affiliation |
basement room no. zero department of pediatric and preventive dentistry, DY Patil school of dentistry sector 7 nerul navi mumbai Maharashtra 400706 india |
| Address |
basement room no. zero department of pediatric and preventive dentistry, DY Patil school of dentistry sector 7 nerul navi mumbai Maharashtra 400706 india
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9769600440 |
| Fax |
|
| Email |
shilpa.naik@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| basement room no. zero department of pediatric and preventive dentistry, DY Patil school of dentistry sector 7 nerul navi mumbai Maharashtra 400706 india |
|
|
Primary Sponsor
|
| Name |
dy patil school of dentistry navi mumbai |
| Address |
basement room no. zero department of pediatric and preventive dentistry, DY Patil school of dentistry sector 7 nerul navi mumbai Maharashtra 400706 india |
| 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 |
| SHIRIN CHAVAN |
DY Patil School of Dentistry |
basement room no. zero department of pediatric and preventive dentistry, DY Patil school of dentistry sector 7 nerul navi mumbai Maharashtra 400706 india
Mumbai
MAHARASHTRA |
7030749055
chavanshirin42@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional research and ethical board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy children 5-9 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cotton roll (sterile cotton rolls) (absorbant) |
The participants received cotton roll isolation prior to silver diamine fluoride application. |
| Intervention |
opaldam (ultradent)
optradam (ivoclar) |
The participants received Opaldam isolation prior to silver diamine fluoride application. A thick layer of 4-6 mm of Opaldam resin is applied on the gingiva to seal the interproximal spaces and 0.5 mm onto dry enamel to seal tooth. Light cure in scanning motion for 20 secs.
The participants received Optradam isolation according to manufacturer’s instructions prior to silver diamine fluoride application. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Children in the age group of 5-9 years with moderate caries in primary mandibular first and second molars.
Children having no history of allergy against silver particles or latex.
Parents who gave consent for discoloration after silver diamine fluoride application.
|
|
| ExclusionCriteria |
| Details |
Children with pulpal carious primary molars.
Children having psychological disorders, under medications with systemic illness.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comfort of three different types of isolation techniques in primary molars during silver diamine fluoride application |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Acceptance of three different isolation techniques in primary molars during silver diamine fluoride application |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="39"
Sample Size from India="39"
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 2 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="1"
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 aim of the present study will be to evaluate and compare the comfort and acceptance of three different methods of isolation- Cotton roll, OpalDam and OptraDam during silver diamine fluoride application in primary mandibular molars in children.
The children will be randomly divided into 3 groups based on computer-generated randomization. 39 children having at least one carious primary mandibular molar will be included in this study. Group I (n = 13): The participants will receive cotton roll isolation prior to silver diamine fluoride application. Group II (n = 13): The participants will receive Opaldam isolation prior to silver diamine fluoride application. A thick layer of 4-6 mm of Opaldam resin will be applied on the gingiva to seal the interproximal spaces and 0.5 mm onto dry enamel to seal the tooth. Light cure in scanning motion for 20 secs. Group III (n=13) - The participants will receive Optradam isolation according to manufacturer’s instructions prior to silver diamine fluoride application. In all three groups, silver diamine fluoride will be applied to the tooth using a bent microsponge brush. The brush will be dipped into the SDF and then dabbed on the side of a plastic dappen dish to remove excess liquid before application. The application time will be at least one minute, if possible. Afterward, a gentle flow of compressed air will be used until the medicament will be dry. Efforts will be made to maintain isolation for up to three minutes. Assessment will be performed using Wong-Baker FACES pain rating scale and Patient Satisfaction questionnaire will be given to the patient. High vacuum suction and Vaseline will be used with all the three isolation groups for standardising the procedure. The first part of the questionnaire will include data regarding age, gender, and each patient’s previous experience with dental isolation. The second part will consist of six questions on a numerical scale from zero to 10 for the subjects to rate their experiences in relation to noise, gagging sensation, fluid leaking, stretching pressure, and discomfort associated with the isolation systems. Zero on the numerical scale represented the complete absence of the irritating factors, while 10 represented the presence of the irritating factors at all times during the procedure except the last question, where zero represented discomfort during isolation.
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