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

Sponsors

Lead Sponsor: Arwa Owais

Collaborator: Delta Dental of Iowa

Source University of Iowa
Brief Summary

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.

Detailed 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.

Overall Status Completed
Start Date 2014-07-01
Completion Date 2018-08-21
Primary Completion Date 2017-08-24
Phase Early Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in baseline Caries Experience and activity (Incidence of caries in primary teeth) through study completion, for 2 years
Secondary Outcome
Measure Time Frame
Caries activity in primary teeth through study completion, for 2 years
Enrollment 122
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Prophylaxis

Description: 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.

Other Name: Prophy

Intervention Type: Drug

Intervention Name: Fluoride varnish

Description: 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.

Other Name: Fluoride

Intervention Type: Drug

Intervention Name: Silver Nitrate

Description: 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.

Arm Group Label: Silver Nitrate group

Eligibility

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.

Gender:

All

Minimum Age:

2 Years

Maximum Age:

11 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Location
Facility: UIowa
Location Countries

United States

Verification Date

2019-07-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: University of Iowa

Investigator Full Name: Arwa Owais

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: conventional treatment group

Type: Other

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

Label: Silver Nitrate group

Type: Other

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking Description: the radiographic progression of caries is assessed by a masked investigator

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