| CTRI Number |
CTRI/2025/06/088938 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing one-visit and two-visit treatments using a layer of tooth protecting silver liquid and filling with tooth-colored material for cavities on the chewing surfaces of baby back teeth |
|
Scientific Title of Study
|
Clinical Effectiveness of Single-visit and Two-visit Silver Modified Atraumatic Restorative Treatment versus Conventional Restorative Treatment for Occlusal Carious Lesions in Primary Molars: A Randomized Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chaithra M |
| Designation |
Postgraduate Student |
| Affiliation |
Manipal College of Dental Sciences Mangalore |
| Address |
Department of Pediatric and Preventive Dentistry Manipal College of Dental Sciences Lighthouse Hill Road Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9916511900 |
| Fax |
|
| Email |
chaithra.mcodsmlr2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chaithra M |
| Designation |
Postgraduate Student |
| Affiliation |
Manipal College of Dental Sciences Mangalore |
| Address |
Department of Pediatric and Preventive Dentistry Manipal College of Dental Sciences Lighthouse Hill Road Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9916511900 |
| Fax |
|
| Email |
chaithra.mcodsmlr2024@learner.manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suprabha BS |
| Designation |
Professor |
| Affiliation |
Manipal College of Dental Sciences Mangalore |
| Address |
Department of Pediatric and Preventive Dentistry Manipal College of Dental Sciences Mangalore Light House Hill Road Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
08242428716 |
| Fax |
|
| Email |
suprabha.bhat@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences, Light house hill road, Mangalore, Karnataka, India- 575001 |
|
|
Primary Sponsor
|
| Name |
Manipal College of Dental Sciences Mangalore |
| Address |
Lighthouse Hill Road Hampankatta Mangalore 575001 Karnataka |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Chaithra M |
Manipal College of Dental Sciences Mangalore |
Department of Pediatric and Preventive Dentistry Room no 6 Second Floor Manipal College of Dental Sciences Mangalore Lighthouse Hill Road Hampankatta Mangalore
Dakshina Kannada
KARNATAKA |
9916511900
chaithra.mcodsmlr2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Manipal College of Dental Sciences Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A-One Visit Silver Modified Atruamatic Restorative Treatment
Group B- Two visit Silver Modified Atraumatic Restorative Treatment |
Group A- Application of silver diamine fluoride followed by immediate restoration with high viscosity glass ionomer cement in same visit.
Group B- Application of silver diamine fluoride in first visit and restoration with high viscosity glass ionomer after 2 week gap |
| Comparator Agent |
Group C- Conventional restorative treatment with high viscosity glass ionomer |
Restoration with high viscosity glass ionomer cement without silver diamine fluoride application. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children with carious lesion on occlusal surface of primary molar teeth with ICDAS score of 4 (with visible enamel breakdown) ICDAS score 5, and with radiolucency extending not more than middle third of dentin (RB 4) will be included |
|
| ExclusionCriteria |
| Details |
1. Children with systemic or mental illnesses
2. Teeth nearing exfoliation
3. Teeth with developmental defects
4. History of allergy to silver or fluoride.
5. Patients with ulceration or stomatitis.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinically acceptable/unacceptable restorations using United State Public Health Service (USPHS) criteria
|
6 months and 12 months follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for restorations and parental satisfaction regarding color of the restorations |
6 months and 12 months follow up |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
01/07/2025 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study is to evaluate and compare the clinical effectiveness of single-visit and two-visit SMART with conventional HVGIC restorations for the treatment of primary molars with occlusal carious lesions over a 12-month period. The study will be conducted in the Department of Pediatric and Preventive Dentistry, MCODS Mangalore. Children will be divided into 3 groups: Group 1: SDF + HVGIC restoration in single visit Group 2: SDF + HVGIC restoration in two visits Group 3: Conventional HVGIC restoration (Positive control) In group 1 : Entry will be gained using enamel hatchet/airotor with bur, caries excavation will be done with spoon excavator, only from the walls. SDF will be applied and HVGIC restoration will be done in the same appointment. In group 2 : Entry will be gained using enamel hatchet/airotor with bur, caries excavation will be done with spoon excavator, only from the walls and SDF will be applied. HVGIC restoration will be done after 2 weeks. In group 3: Caries excavation will be done using airotor and bur on the walls, spoon excavator will be used to excavate caries from the pulpal floor and HVGIC restoration will be done in the same appointment. The restorations will be evaluated at 6 months and 12 months follow up using modified USPHS criteria. |