| CTRI Number |
CTRI/2023/10/058857 [Registered on: 19/10/2023] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of silver modified fillings performed after caries removal with hand instruments on the chewing surface of molar milk teeth - A clinical study. |
|
Scientific Title of Study
|
Clinical Effectiveness of Silver Modified Atraumatic Restoration with Potassium Iodide Application versus Atraumatic Restorative Treatment for Treating Occlusal Caries in Primary Molars – A Randomized Controlled Study
|
| Trial Acronym |
SMART |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohita Arora |
| Designation |
Post Graduate 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 |
9353514423 |
| Fax |
08242422653 |
| Email |
rohita.mcodsmlr2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohita Arora |
| Designation |
Post Graduate 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 |
9353514423 |
| Fax |
08242422653 |
| Email |
rohita.mcodsmlr2022@learner.manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suprabha BS |
| Designation |
Professor and Head |
| 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 |
08242428716 |
| Fax |
|
| Email |
suprabha.bhat@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences, Mangalore |
|
|
Primary Sponsor
|
| Name |
Manipal College of Dental Sciences |
| Address |
Light House 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 Rohita Arora |
Manipal College of Dental Science, Mangalore |
Department of Pediatric and Preventive Dentistry, Room no 5, second floor, Manipal College of Dental Sciences,Mangalore, Lighthouse Hill Road, Hampankatta, Mangalore - 575001
Dakshina Kannada
KARNATAKA |
09353514423
rohita.mcodsmlr2022@learner.manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| 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 |
| Comparator Agent |
GC Fuji IX GP Radiopaque posterior glass ionomer restorative cement, GC Corporation,(Tokyo, Japan) |
The high strength strontium-based glass ionomer restorative cement powder and liquid (Fuji IX) will be dispensed as 1 scoop of powder and 1 drop of liquid and mixed using plastic spatula. The mixed cement will be placed in the cavity using a plastic cement carrier instrument.Slight finger pressure
will be applied with the gloved finger coated with a layer of petroleum jelly and excess material will be removed with a carver. |
| Intervention |
Riva Star Silver Diamine fluoride(SDF),SDI Limited(Bayswater,Victoria,Australia) with GC Fuji IX GP Radiopaque posterior glass ionomer restorative cement, GC Corporation,(Tokyo, Japan)
|
One drop of SDF liquid will be dispensed in the plastic dappen dish (Silver Bottle - Step 1).A micro sponge brush will be used to apply the SDF to the carious tooth surface and left for 3 minutes. One drop of Potassium Iodide liquid (Green Bottle - Step 2) will be applied on the SDF treated carious lesion using a separate microbrush.It will be applied repeatedly until the white precipitate turns colorless and the excess will be rinsed away. The tooth will be air dried before proceeding for further restoration with High Viscosity Glass Ionomer Cement (GC Fuji IX GP Radiopaque posterior glass ionomer restorative cement) using the same method as in comparater agent. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children with carious lesion on the occlusal surface of primary molar teeth that are active(dentin feels soft or leathery on gentle probing) with ICDAS score of 4 with visible enamel breakdown, ICDAS score 5 and ICDAS score 6 (wide cavities extending to more than half occlusal surface) with radiolucency extending not more than middle third ofdentin (RB 4) will be included.
|
|
| ExclusionCriteria |
| Details |
1. Children with systemic and mental illnesses.
2. Tooth with deep carious lesion, involving the pulp.
3. Radiographic evidence of pulpal involvement, periapical pathology.
4. Teeth nearing the exfoliation time |
|
|
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. |
The restorations will be evaluated at 6 months & 12 months follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A comparison of the time taken for restoration & parental satisfaction regarding the color of the restoration between the conventional ART and SMART restoration with KI application |
The restorations will be evaluated at 6 months & 12 months follow up. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "126"
Final Enrollment numbers achieved (India)="126" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/10/2023 |
| Date of Study Completion (India) |
20/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/03/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
TheT The aim of this randomised active controlled parallel group study was to evaluate the clinical effectiveness of high viscosity glass ionomer cement (HVGIC) restorations placed using atraumatic restorative treatment (ART) technique in primary molars with dentinal carious lesions on the occlusal surfaces, placed after silver diamine fluoride (SDF) and potassium iodide (KI) application in comparison with conventional ART technique. The time taken for the restorations and parents’ satisfaction regarding the restoration colour were the secondary outcomes. The trial included 65 participants aged 4-10 years, involving 126 primary molar teeth with caries on occlusal surface with ICDAS score 4 and 5. The teeth were randomised into, Group I – ART (Control group), Group II – silver modified atraumatic restorative treatment (SMART) with KI application. The restorations were evaluated at 6 and 12 months according to modified United States Public Health Service (USPHS) criteria. Statistical analysis included Chi-square test, Mann-Whitney U, Kaplan Meir survival analysis and logistic regression analysis. The Kaplan Meier results revealed comparable results in survival of restorations in both the groups. Regression analysis identified socioeconomic status, plaque index and brushing frequency to be the confounding factors affecting the survival of restorations in both the groups. There was no statistically significant difference in the time for performing the restorations and parent’s satisfaction for the colour of the restoration in both the groups. Both ART and SMART with KI techniques showed acceptable clinical performance at 12 months follow-up. The additional steps of SDF+KI application did not provide significant advantages for restoration survival, parent satisfaction and time taken for restoration in comparison with conventional ART protocol.
|