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Completed

NCT Number: NCT02604134

Medical Management of Caries in the Primary Dentition Using Silver Nitrate

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UIowa

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prophylaxis

Procedure

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 names: Prophy

Fluoride varnish

Drug

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 names: Fluoride

Silver Nitrate

Drug

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.

Primary outcomes

  1. Change in baseline Caries Experience and activity (Incidence of caries in primary teeth)

    Time frame: through study completion, for 2 years

    Detailed measurements of caries experience will be recorded at baseline and annual caries examination using EC4

Secondary outcomes

  1. Caries activity in primary teeth

    Time frame: through study completion, for 2 years

    Detailed measurements of caries activity will be recorded at baseline and annual caries examination using Nyvad scores.

Other outcomes

  1. Pain (toothache) and/or infection in primary teeth

    Time frame: through study completion, for 2 years

    Assessments for pain from toothache will be made at each visit throughout the patient's participation in the trial using the Dental Discomfort Questionnaire completed by the parents.

  2. Patient quality of life

    Time frame: through study completion, for 2 years

    Quality of life will be assessed through direct reporting by parents and children about pain and related activities

  3. Cost-effectiveness

    Time frame: through study completion, for 2 years

    Cost-effectiveness for both groups will be calculated and compared

  4. Acceptability of treatment strategies by parents and children

    Time frame: through study completion, for 2 years

    Acceptability is checked throughout the whole period of the study every time the patient comes in for a recall

Sponsors and collaborators

Lead sponsor

Arwa Owais

Other

Collaborators

  • Delta Dental of Iowa

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Nov 13, 2015
Registry last updated
Jul 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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