Clinical trial NCT02604134: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Dental Caries
Keywords: silver nitrate
children
dental caries
medical management
quality of life
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Delta Dental of Iowa
First posted: 2015-11-13
Enrollment: 122
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in baseline Caries Experience and activity (Incidence of caries in primary teeth)
timeFrame: through study completion, for 2 years
Secondary outcomes:
measure: Caries activity in primary teeth
timeFrame: through study completion, for 2 years
Other outcomes:
measure: Pain (toothache) and/or infection in primary teeth
timeFrame: through study completion, for 2 years
measure: Patient quality of life
timeFrame: through study completion, for 2 years
measure: Cost-effectiveness
timeFrame: through study completion, for 2 years
measure: Acceptability of treatment strategies by parents and children
timeFrame: through study completion, for 2 years
Locations:
city: Iowa City
country: United States
facility: UIowa
state: Iowa
Study officials:
affiliation: Associate Profesor in Pediatric Dentistry
name: Arwa I Owais, BDS, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor in Pediatric Dentistry & Dean for Patient Cares
name: MIchael Kanellis, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duffin S. Back to the future: the medical management of caries introduction. J Calif Dent Assoc. 2012 Nov;40(11):852-8.
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.
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.
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.
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.
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.
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.
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.
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.
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.