Medical Management of Caries in the Primary Dentition Using Silver Nitrate

Arwa Owais

Status and phase: Completed; Early Phase 1

Conditions: Dental Caries

Treatments: Drug: Fluoride varnish; Drug: Silver Nitrate; Procedure: Prophylaxis

Study type: Interventional

Funder types: Other

Identifiers

NCT02604134

201406792

Details and patient eligibility

About

This pilot trial compares conventional restorations with a new strategy based on the medical management of caries using silver nitrate and fluoride varnish with no restorations.

Full description

This is a two-arm, parallel group, patient-randomized controlled pilot trial. Children with at least one primary tooth where caries extends into dentine. Children will be randomized and treated according to one of two treatment approaches;(1) conventional caries management with best practice prevention, or (2) medical management of caries using silver nitrate with best practice prevention.

Baseline measures and outcome data (at treatment/review during two year follow-up) are assessed through direct reporting, clinical examination including blinded radiographic assessment, and child/parent questionnaires.

Enrollment: 122 patients

Sex: All

Ages: 2 to 11 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Presense of one or more cavitated carious lesions in the primary dentition, extending into dentin but not encroaching on the pulp.
• Absense of any spontaneous or elicited pain due to caries, or signs of pulpal infection in response to any of the carious lesions in the primary dentition to be included in the study

Exclusion criteria

• Hereditary developmental defects of the teeth such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta
• Medical conditions that prevent treatment of the child in the outpatient clinic. These conditions include severe bleeding disorders, cardiac problems and mental disabilities that prevent child from communication with the research team.
• Known allergy/sensitivity to any of the dental materials.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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122 participants in 2 patient groups

conventional treatment group

Other group

Description:

The child will receive a prophylaxis and fluoride varnish. Parents will fill out a parent and a child questionnaire.

Treatment:

Procedure: Prophylaxis

Drug: Fluoride varnish

Silver Nitrate group

Other group

Description:

The child will receive a prophylaxis, then silver nitrate and then fluoride varnish. Parents will fill out a parent and a child questionnaire.

Treatment:

Procedure: Prophylaxis

Drug: Fluoride varnish

Drug: Silver Nitrate