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Medical Management of Caries in the Primary Dentition Using Silver Nitrate

Primary Purpose

Dental Caries

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Prophylaxis

Fluoride varnish

Silver Nitrate

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring silver nitrate, children, dental caries, medical management, quality of life

Eligibility Criteria

2 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

UIowa

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

conventional treatment group

Silver Nitrate group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Caries activity in primary teeth

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

Full Information

NCT ID

NCT02604134

First Posted

October 28, 2015

Last Updated

July 9, 2019

Sponsor

Arwa Owais

Collaborators

Delta Dental of Iowa

1. Study Identification

Unique Protocol Identification Number

NCT02604134

Brief Title

Medical Management of Caries in the Primary Dentition Using Silver Nitrate

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

August 24, 2017 (Actual)

Study Completion Date

August 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Arwa Owais

Collaborators

Delta Dental of Iowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

Keywords

silver nitrate, children, dental caries, medical management, quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

the radiographic progression of caries is assessed by a masked investigator

Allocation

Randomized

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

conventional treatment group

Arm Type

Other

Arm Description

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

Arm Title

Silver Nitrate group

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Prophylaxis

Other Intervention Name(s)

Prophy

Intervention 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.

Intervention Type

Drug

Intervention Name(s)

Fluoride varnish

Other Intervention Name(s)

Fluoride

Intervention 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.

Intervention Type

Drug

Intervention Name(s)

Silver Nitrate

Intervention 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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

through study completion, for 2 years

Secondary Outcome Measure Information:

Title

Caries activity in primary teeth

Description

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

Time Frame

through study completion, for 2 years

Other Pre-specified Outcome Measures:

Title

Pain (toothache) and/or infection in primary teeth

Description

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.

Time Frame

through study completion, for 2 years

Title

Patient quality of life

Description

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

Time Frame

through study completion, for 2 years

Title

Cost-effectiveness

Description

Cost-effectiveness for both groups will be calculated and compared

Time Frame

through study completion, for 2 years

Title

Acceptability of treatment strategies by parents and children

Description

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

Time Frame

through study completion, for 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arwa I Owais, BDS, MS

Organizational Affiliation

Associate Profesor in Pediatric Dentistry

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

MIchael Kanellis, DDS, MS

Organizational Affiliation

Professor in Pediatric Dentistry & Dean for Patient Cares

Official's Role

Principal Investigator

Facility Information:

Facility Name

UIowa

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23270129

Citation

Duffin S. Back to the future: the medical management of caries introduction. J Calif Dent Assoc. 2012 Nov;40(11):852-8. Erratum In: J Calif Dent Assoc. 2012 Dec;40(12):909.

Results Reference

background

PubMed Identifier

10355008

Citation

Klein U, Kanellis MJ, Drake D. Effects of four anticaries agents on lesion depth progression in an in vitro caries model. Pediatr Dent. 1999 May-Jun;21(3):176-80.

Results Reference

background

PubMed Identifier

22484380

Citation

Peng JJ, Botelho MG, Matinlinna JP. Silver compounds used in dentistry for caries management: a review. J Dent. 2012 Jul;40(7):531-41. doi: 10.1016/j.jdent.2012.03.009. Epub 2012 Apr 3.

Results Reference

background

PubMed Identifier

26331379

Citation

Schwendicke F, Stolpe M, Innes N. Conventional treatment, Hall Technique or immediate pulpotomy for carious primary molars: a cost-effectiveness analysis. Int Endod J. 2016 Sep;49(9):817-826. doi: 10.1111/iej.12537. Epub 2015 Sep 19.

Results Reference

background

PubMed Identifier

25987388

Citation

Innes NP, Stewart M. The Hall Technique, a Simplified Method for Placing Stainless Steel Crowns on Primary Molars, may be as Successful as Traditionally Placed Crowns. J Evid Based Dent Pract. 2015 Jun;15(2):70-2. doi: 10.1016/j.jebdp.2015.03.008. Epub 2015 Mar 28. No abstract available.

Results Reference

background

PubMed Identifier

25415040

Citation

Keightley A, Clarkson J, Maguire A, Speed C, Innes N. Participant recruitment to FiCTION, a primary dental care trial - survey of facilitators and barriers. Br Dent J. 2014 Nov;217(10):E22. doi: 10.1038/sj.bdj.2014.1009.

Results Reference

background

PubMed Identifier

25343394

Citation

Santamaria R, Innes N. Trial shows partial caries removal is an effective technique in primary molars. Evid Based Dent. 2014 Sep;15(3):81-2. doi: 10.1038/sj.ebd.6401044.

Results Reference

background

PubMed Identifier

25216660

Citation

Santamaria RM, Innes NP, Machiulskiene V, Evans DJ, Splieth CH. Caries management strategies for primary molars: 1-yr randomized control trial results. J Dent Res. 2014 Nov;93(11):1062-9. doi: 10.1177/0022034514550717. Epub 2014 Sep 12.

Results Reference

background

PubMed Identifier

26492796

Citation

Lamont T, Schwendicke F, Innes N. Why we need a core outcome set for trials of interventions for prevention and management of caries. Evid Based Dent. 2015 Sep;16(3):66-8. doi: 10.1038/sj.ebd.6401109. No abstract available.

Results Reference

result

PubMed Identifier

26346538

Citation

Schwendicke F, Lamont T, Innes N. Outcomes in Trials for Management of Caries Lesions (OuTMaC): protocol. Trials. 2015 Sep 7;16:397. doi: 10.1186/s13063-015-0927-3.

Results Reference

result

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Medical Management of Caries in the Primary Dentition Using Silver Nitrate

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