| CTRI Number |
CTRI/2024/05/067249 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON BETWEEN Silver Modified Atraumatic Restorative Treatment and Atraumatic Restorative Technique |
|
Scientific Title of Study
|
EFFECTIVENESS OF SILVER MODIFIED ATRAUMATIC RESTORATIVE TREATMENT (SMART) AND ATRAUMATIC RESTORATIVE TREATMENT (ART) FOR MANAGEMENT OF DENTAL CARIES - A RANDOMIZED CONTROLLED TRIAL. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swetha V |
| Designation |
II YEAR POSTGRADUATE DEPT OF PUBLIC HEALTH DENTISTRY |
| Affiliation |
MEENAKSHI AMMAL DENTAL COLLEGE AND HOSPITAL |
| Address |
ROOM NO -4
DEPARTMENT OF PUBLIC HEALTH DENTISTRY
MEENAKSHI AMMAL DENTAL COLLEGE AND HOSPITAL,CHENNAI
Chennai
TAMIL NADU
600033
India |
| Phone |
9442304494 |
| Fax |
|
| Email |
contactswethavenkat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PREETHA ELIZABETH CHALY |
| Designation |
PROF AND HEAD DEPARTMENT OF PUBLIC HEALTH DENTISTRY |
| Affiliation |
MEENAKSHI AMMAL DENTAL COLLEGE AND HOSPITAL |
| Address |
ROOM NO 4
DEPARTMENT OF PUBLIC HEALTH DENTISTRY
MEENAKSHI AMMAL DENTAL COLLEGE AND HOSPITAL CHENNAI
Chennai
TAMIL NADU
600033
India |
| Phone |
9840330834 |
| Fax |
|
| Email |
drpchaly@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swetha V |
| Designation |
II YEAR POSTGRADUATE DEPARTMENT OF PUBLIC HEALTH DENTISTRY |
| Affiliation |
MEENAKSHI AMMAL DENTAL COLLEGE AND HOSPITAL |
| Address |
ROOM NO 4
DEPARTMENT OF PUBLIC HEALTH DENTISTRY
MEENAKSHI AMMAL DENTAL COLLEGE AND HOSPITAL CHENNAI
Chennai
TAMIL NADU
600033
India |
| Phone |
9442304494 |
| Fax |
|
| Email |
contactswethavenkat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dengen Dental Prodcuts Private Limited.
Haryana, India.
Contact number: 9991000945 |
|
|
Primary Sponsor
|
| Name |
Dr Preetha Elizabeth Chaly |
| Address |
MEENAKSHI AMMAL DENTAL COLLEGE AND HOSPITAL CHENNAI -95 |
| 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 Swetha |
Meenakshi Ammal Dental College and Hospital |
1, Alapakkam Main Road, Maduravoyal, Chennai - 600095
Chennai
TAMIL NADU |
9442304494
contactswethavenkat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MEENAKSHI ACADEMY OF HIGHER EDUCATION AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
APPARENTLY HEALTHY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Manual Spoon excavation of caries |
Caries will be removed using spoon excavator until caries is completely removed and then will be restored using glass ionomer cement |
| Intervention |
Silver Diamine fluoride (SDF) application |
Silver diamine fluoride (SDF) will be applied over carious tooth for 1 minute and will be then restored with glass ionomer cement |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with bilaterally symmetrical permanent molar teeth with occlusal carious lesion with ICDAS criteria code 5 & 6.
2. Children whose Legally authorized representatives give informed consent to participate in the study.
3. Children who give verbal consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Carious tooth with pulpal involvement Destruction of more than 1/3rd of crown
Children with special needs such as physically or mentally challenged children.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Survival rate of the restoration |
Survival rate of the restoration
will be assessed at baseline, 3,6,9 and 12 months respectively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| incidence of secondary caries and patients’ satisfaction. |
3,6,9 AND 12 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
30/05/2024 |
| 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="1"
Months="0"
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
|
The study will be done to compare between Silver Modified Atraumatic Restorative Treatment and Atraumatic Restorative Treatment. This study is done to assess which treatment outcome is better for individuals. This study will help in assessing the best minimally invasive treatment for carious tooth
|