Medical Management of Caries in the Primary Dentition Using Silver Nitrate

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02604134
• Other study ID #: 201406792
• Status: Completed
• Phase: Early Phase 1
• Start date: July 2014
• Est. completion date: August 21, 2018

Study information

• Verified date: July 2019
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 21, 2018
• Est. primary completion date: August 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries

Intervention

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.

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.
• 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.

Locations

Country	Name	City	State
United States	UIowa	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Arwa Owais	Delta Dental of Iowa

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain (toothache) and/or infection in primary teeth	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.	through study completion, for 2 years
Other	Patient quality of life	Quality of life will be assessed through direct reporting by parents and children about pain and related activities	through study completion, for 2 years
Other	Cost-effectiveness	Cost-effectiveness for both groups will be calculated and compared	through study completion, for 2 years
Other	Acceptability of treatment strategies by parents and children	Acceptability is checked throughout the whole period of the study every time the patient comes in for a recall	through study completion, for 2 years
Primary	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	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