Medical Management of Caries in the Primary Dentition Using Silver Nitrate

Study Overview
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Brief Summary
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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
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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.

Official Title
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Medical Management of Caries in the Primary Dentition Using Silver Nitrate: A Pilot Study

Conditions
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Dental Caries

Intervention / Treatment
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* Procedure: Prophylaxis
* Drug: Fluoride varnish
* Drug: Silver Nitrate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: conventional treatment group<br>The child will receive a prophylaxis and fluoride varnish. Parents will fill out a parent and a child questionnaire. | Procedure: Prophylaxis<br>* 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.<br>* Other names: Prophy;Drug: Fluoride varnish<br>* 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.<br>* Other names: Fluoride;|
| Other: Silver Nitrate group<br>The child will receive a prophylaxis, then silver nitrate and then fluoride varnish. Parents will fill out a parent and a child questionnaire. | Procedure: Prophylaxis<br>* 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.<br>* Other names: Prophy;Drug: Fluoride varnish<br>* 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.<br>* Other names: Fluoride;Drug: Silver Nitrate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline Caries Experience and activity (Incidence of caries in primary teeth) | Detailed measurements of caries experience will be recorded at baseline and annual caries examination using EC4 | through study completion, for 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries activity in primary teeth | Detailed measurements of caries activity will be recorded at baseline and annual caries examination using Nyvad scores. | through study completion, for 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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silver nitrate, children, dental caries, medical management, quality of life