Health Condition 1: K025- Dental caries on pit and fissure surface
Conditions
Interventions
Intervention1: 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 applie
Sponsors
KLE VK Institute of Dental Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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. | — |
Countries
India
Contacts
Public ContactDr Biswadeep Roychowdhury
KLE VK INSTITUTE OF DENTAL SCIENCES, Belgaum
Outcome results
None listed