NCT02604134

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2014

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2017

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2018

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

3.2 years

First QC Date

October 28, 2015

Last Update Submit

July 9, 2019

Conditions

Dental Caries

Keywords

silver nitratechildrendental cariesmedical managementquality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Caries activity in primary teeth

    through study completion, for 2 years

Other Outcomes (4)

  • Pain (toothache) and/or infection in primary teeth

    through study completion, for 2 years

  • Patient quality of life

    through study completion, for 2 years

  • Cost-effectiveness

    through study completion, for 2 years

  • +1 more other outcomes

Study Arms (2)

conventional treatment group

OTHER

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

Procedure: ProphylaxisDrug: Fluoride varnish

Silver Nitrate group

OTHER

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

Procedure: ProphylaxisDrug: Fluoride varnishDrug: Silver Nitrate

Interventions

ProphylaxisPROCEDURE

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.

Also known as: Prophy
Silver Nitrate groupconventional treatment group
Fluoride varnishDRUG

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.

Also known as: Fluoride
Silver Nitrate groupconventional treatment group
Silver NitrateDRUG

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.

Silver Nitrate group

Eligibility Criteria

Age2 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UIowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (10)

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

    PMID: 23270129BACKGROUND

  • 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.

    PMID: 10355008BACKGROUND

  • 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.

    PMID: 22484380BACKGROUND

  • 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.

    PMID: 26331379BACKGROUND

  • 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.

    PMID: 25987388BACKGROUND

  • 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.

    PMID: 25415040BACKGROUND

  • 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.

    PMID: 25343394BACKGROUND

  • 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.

    PMID: 25216660BACKGROUND

  • 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.

    PMID: 26492796RESULT

  • 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.

    PMID: 26346538RESULT

MeSH Terms

Conditions

Dental Caries

Interventions

FluoridesSilver Nitrate

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

AnionsIonsElectrolytesInorganic ChemicalsHydrofluoric AcidFluorine CompoundsNitratesNitric AcidNitrogen CompoundsSilver Compounds

Study Officials

  • Arwa I Owais, BDS, MS

    Associate Profesor in Pediatric Dentistry

    PRINCIPAL INVESTIGATOR

  • MIchael Kanellis, DDS, MS

    Professor in Pediatric Dentistry & Dean for Patient Cares

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
the radiographic progression of caries is assessed by a masked investigator
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 28, 2015

First Posted

November 13, 2015

Study Start

July 1, 2014

Primary Completion

August 24, 2017

Study Completion

August 21, 2018

Last Updated

July 11, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)