| CTRI Number |
CTRI/2026/02/103328 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two simple tooth-filling methods in prison inmates. |
|
Scientific Title of Study
|
Comparative evaluation of longevity and economic efficiency of silver-modified atraumatic restorative treatment (SMART) and conventional atraumatic restorative treatment (ART) in permanent molars among prison inmates: A randomized control trial. |
| 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 Biswadeep Roychowdhury |
| Designation |
Post Graduate |
| Affiliation |
KLE VK INSTITUTE OF DENTAL SCIENCES, Belgaum |
| Address |
The Department of Public Health Dentistry is located on the ground floor, Department Number 2, at the KLE VK Institute of Dental Sciences in Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
7003891988 |
| Fax |
|
| Email |
biswadeepr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Biswadeep Roychowdhury |
| Designation |
Post Graduate |
| Affiliation |
KLE VK INSTITUTE OF DENTAL SCIENCES, Belgaum |
| Address |
The Department of Public Health Dentistry is located on the ground floor, Department Number 2, at the KLE VK Institute of Dental Sciences in Belagavi.
KARNATAKA
590010
India |
| Phone |
7003891988 |
| Fax |
|
| Email |
biswadeepr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Biswadeep Roychowdhury |
| Designation |
Post Graduate |
| Affiliation |
KLE VK INSTITUTE OF DENTAL SCIENCES, Belgaum |
| Address |
The Department of Public Health Dentistry is located on the ground floor, Department Number 2, at the KLE VK Institute of Dental Sciences in Belagavi.
KARNATAKA
590010
India |
| Phone |
7003891988 |
| Fax |
|
| Email |
biswadeepr@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE VK Institute of Dental Sciences, Nehru Nagar, JNMC Campus, Belgaum, Karnataka, India. PIN: 590010 |
|
|
Primary Sponsor
|
| Name |
KLE VK Institute of Dental Sciences |
| Address |
JNMC Campus, Nehru Nagar, Belgaum, Karnataka, Pin: 590010 |
| 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 Sagar J |
Hindalga Central Prison |
Hindalga, Belagavi.
Belgaum
KARNATAKA |
7845808792
msakthikarthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
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 |
Conventional Atraumatic Restorative Treatment (ART) |
Infected and softened carious dentine will be removed using hand instruments (spoon excavator and enamel hatchet) until firm dentine is reached, followed by restoration of the cavity with glass ionomer cement (GIC) as per manufacturer’s instructions. |
| Intervention |
Silver-Modified Atraumatic Restorative Treatment (SMART) |
The carious tooth surface will be cleaned of peripheral soft decay, dried, and 38% Silver Diamine Fluoride (SDF) will be applied to the affected dentine using a micro-brush without complete removal of carious dentine, followed by restoration with glass ionomer cement (GIC). |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Incarcerated adults with at least one permanent molar requiring a Class I occlusal restoration due to dental caries.
Permanent molars with dentinal caries without pulpal involvement.
Participants willing to provide written informed consent.
Participants likely to remain available for 12-month follow-up. |
|
| ExclusionCriteria |
| Details |
Teeth with signs of irreversible pulpitis or periapical pathology.
Molars with inadequate remaining tooth structure for restoration.
Previously restored teeth.
Known allergy to glass ionomer cement or silver diamine fluoride.
Participants unable to comply with study procedures or likely to be transferred/released before follow-up completion. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study is the clinical survival of SMART and ART occlusal restorations placed in permanent molars of prison inmates. Restoration survival will be assessed based on standardized clinical criteria, considering factors such as retention of the restoration, marginal integrity, absence of secondary caries, and need for repair or replacement. The comparison between the two treatment modalities will determine which technique demonstrates better longevity under real-world prison settings. |
The primary outcome of the study is the clinical survival of SMART and ART occlusal restorations placed in permanent molars of prison inmates. Restoration survival will be assessed based on standardized clinical criteria, considering factors such as retention of the restoration, marginal integrity, absence of secondary caries, and need for repair or replacement. The comparison between the two treatment modalities will determine which technique demonstrates better longevity under real-world prison settings. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome of the study is to evaluate and compare the cost-effectiveness of SMART and ART occlusal restorations in permanent molars among prison inmates. This will include assessment of total treatment time, material costs, number of clinical visits required, and need for retreatment or repair. In addition, factors influencing the success or failure of restorations, such as oral hygiene status, caries risk, and tooth-related factors, will be analyzed to understand their impact on clinical performance. |
Data related to treatment time and immediate procedural costs will be recorded at the time of restoration placement (baseline). Follow-up assessments for secondary outcomes, including need for repair, retreatment, or failure of restorations, will be conducted at 6 months and 12 months after treatment, in alignment with the clinical evaluation schedule. |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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
|
N/A |
|
Date of First Enrollment (India)
|
17/02/2026 |
| 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 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
|
This randomized controlled trial aims to compare two simple, minimally invasive methods of treating tooth decay—Silver-Modified Atraumatic Restorative Treatment (SMART) and conventional Atraumatic Restorative Treatment (ART)—in permanent back teeth of prison inmates. The study will evaluate which technique provides better longevity of dental fillings and is more cost-effective in a resource-limited prison setting. Eligible inmates with decayed permanent molars will be randomly assigned to receive either SMART or ART, and the restorations will be assessed over a 12-month period. The findings are expected to help identify a practical and sustainable dental treatment approach for improving oral health care in correctional institutions. |