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Iowa City, Iowa 52242


Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT02604134


Primary Contact:

Principal Investigator
Arwa I Owais, BDS, MS
Associate Profesor in Pediatric Dentistry


Backup Contact:

N/A


Location Contact:

Iowa City, Iowa 52242
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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