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A study to assess the effectiveness of a silver and fluoride containing re-mineralizing agent on arresting the progression of tooth decay.

Effectiveness of 38% silver diamine fluoride application along with atraumatic restorative treatment on cavitated carious lesion of permanent teeth in adults compared to atraumatic restorative treatment - A randomized controlled trial. - SD-ART

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038816
Enrollment
220
Registered
2021-12-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K025- Dental caries on pit and fissure surface Health Condition 2: K026- Dental caries on smooth surface

Interventions

Intervention1: 38%SDF and ART: The caries lesion entrance will be widened and with help of a dental hatchet the thin unsupported frangible enamel will removed. In the next step the decayed tissue will

Sponsors

Amrita School of dentistry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or Female individuals, between the age of 18 to 65 years, with either one of these caries: Class 1 Caries (only occlusal surface involved in posterior teeth) or Class 2 Caries (occlusal and proximal surface of posterior teeth), without involving the pulp. 2. Patients understand the significance of SDF and ART treatment to prevent tooth decay. 3. Patients are willing to attend the follow up visits as required for the trial. 4. The Patient will be enrolled irrespective of special needs if the subject is willing and able to comply with all the trial requirements. 5. Patients with absence of periodontal disease.

Exclusion criteria

Exclusion criteria: 1. Patient with stomatitis or ulcerative gingivitis. 2. Developmental abnormalities of enamel and dentin. 3. Serious non-communicable medical conditions including cardiac failure, poor glycaemic control. 4. Cavitated teeth missing greater than a third of the coronal tooth structure or having pulpal involvement. The pulp exposed tooth, obvious discoloration, premature hypermobility, and presence of a periapical abscess or a sinus, will be regarded as a tooth with pulpal involvement. 5. Known silver allergy.

Design outcomes

Primary

MeasureTime frame
The objective of the clinical trial is to compare the effect of application of 38% SDF along with atraumatic restorative treatment against atraumatic restorative treatment alone in arresting active occlusal carious lesions on permanent teeth. It also intends to compare the survival of the restoration.Timepoint: 7th day, 30th day and 180th day

Secondary

MeasureTime frame
patient satisfaction, and acceptability of the application of the SDF.Timepoint: 7th day, 30th day and 180th day

Countries

India

Contacts

Public ContactChandrashekar Janakiram

Amrita School of Dentistry

sekarcandra@gmail.com9446227870

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 11, 2026