Partial caries removal with and without SDF (caries arresting agent) and restoration in children

Phase 4

Completed

• Conditions: Dental caries, unspecified,

• Registration Number: CTRI/2021/01/030479
• Lead Sponsor: Dr Harsh Sachdev

Brief Summary

Silver diamine fluoride (SDF) is widely used for dental caries management in arresting caries and promotes remineralization. Studies have reported a good success rate with partial excavation and restoration with RMGIC. A total of 222 patients will be recruited for the intervention and will be randomly allocated into both the group the intervention group (SDF) and control group.

In both the groups, the caries from the walls will be excavated using a sharp spoon excavator, leaving the soft dentinal caries on the floor intact. In the test group, a solution of 38% SDF will be applied and kept in contact with tooth surface for 3 minutes. In the control group a solution of distilled water will be applied and kept in contact with tooth surface for 3 minutes. Patient will be asked to rinse and a definitive restoration will be done using RMGIC in both the groups. Both groups will be assessed for survival of restoration, marginal integrity and clinical signs of caries progression at 1, 6 and 12 months and radiographic assessment of caries progression at 6 and 12 months. Success rate of intervention will be assessed as survival rate of the restoration (intact or dislodged) and marginal integrity of restoration and will be recorded as a binary categorical variable. Clinical signs of caries progression will be assessed as the presence or absence of pain, swelling, fistula, mobility or abscess and recorded as a binary categorical variable.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-15
• Study Completion: 2022-10-05
• Last Update Posted: 2022-12-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

• 1.Primary molars with dentinal caries in otherwise healthy children.
• 2.Children whose parents give consent for the application of SDF.

Exclusion Criteria

• 1.Tooth with history, clinical or radiographic signs indicative of pulpal and peri-radicular pathology.
• 2.Children suffering from any systemic condition that may hinder with their participation in the study.
• 3.Children with known allergy to any material used in the study.
• 4.Children who cannot co-operate while performing the procedure.
• 5.Children whose parents refuse to give consent for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival of Restoration and Marginal Integrity of the Restoration.	After the intervention survival of restoration will be checked at 1 month, 6 months, 12 months respectively. | After the intervention Marginal Integrity of restoration will be checked at 1 month, 6 months, 12 months respectively.

Secondary Outcome Measures

Name	Time	Method
Parents acceptance of application of silver diamine flouride	After application of SDF parents acceptance of black staining for the silver diamine flouride

Trial Locations

Locations (1)

Y.M.T dental college and hospital; 🇮🇳 Raigarh, MAHARASHTRA, India

Y.M.T dental college and hospital

🇮🇳Raigarh, MAHARASHTRA, India

Dr Harsh Sachdev

Principal investigator

9167720233

harsh.sachdev9@gmail.com