Title
Medical Management of Caries in the Primary Dentition Using Silver Nitrate
Medical Management of Caries in the Primary Dentition Using Silver Nitrate: A Pilot Study
Phase
Early Phase 1Lead Sponsor
University of IowaStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Dental CariesIntervention/Treatment
sodium fluoride (18F) silver nitrate ...Study Participants
122This 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.
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.
A dental prophylaxis is a cleaning procedure performed to thoroughly clean the teeth. Prophylaxis is an important dental treatment for halting the progression of periodontal disease and gingivitis.
Fluoride varnish is a highly concentrated form of fluoride which is applied to the tooth's surface, by a dentist, dental hygienist or other health care professional, as a type of topical fluoride therapy.
a small amount will be applied to the tooth via a cotton applicator. Silver nitrate is a colorless, odorless, transparent solution used as an escharotic, dehydrating and sclerosing agent.
The child will receive a prophylaxis and fluoride varnish. Parents will fill out a parent and a child questionnaire.
The child will receive a prophylaxis, then silver nitrate and then fluoride varnish. Parents will fill out a parent and a child questionnaire.
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.