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Medical Management of Caries in the Primary Dentition Using Silver Nitrate

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ClinicalTrials.gov Identifier: NCT02604134
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
Delta Dental of Iowa
Information provided by (Responsible Party):
Arwa Owais, 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.

Condition or disease Intervention/treatment Phase
Dental Caries Procedure: Prophylaxis Drug: Fluoride varnish Drug: Silver Nitrate Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: the radiographic progression of caries is assessed by a masked investigator
Primary Purpose: Treatment
Official Title: Medical Management of Caries in the Primary Dentition Using Silver Nitrate: A Pilot Study
Study Start Date : July 2014
Actual Primary Completion Date : August 24, 2017
Actual Study Completion Date : August 21, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
conventional treatment group
The child will receive a prophylaxis and fluoride varnish. Parents will fill out a parent and a child questionnaire.
Procedure: Prophylaxis
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

Drug: Fluoride varnish
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

Silver Nitrate group
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
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

Drug: Fluoride varnish
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

Drug: Silver Nitrate
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 Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02604134


Locations
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United States, Iowa
UIowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Arwa Owais
Delta Dental of Iowa
Investigators
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Principal Investigator: Arwa I Owais, BDS, MS Associate Profesor in Pediatric Dentistry
Principal Investigator: MIchael Kanellis, DDS, MS Professor in Pediatric Dentistry & Dean for Patient Cares

Publications of Results:
Other Publications:

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Responsible Party: Arwa Owais, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT02604134     History of Changes
Other Study ID Numbers: 201406792
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Arwa Owais, University of Iowa:
silver nitrate
children
dental caries
medical management
quality of life
Additional relevant MeSH terms:
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Silver Nitrate
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents