NCT02591147

Brief Summary

This pilot trial is randomized, double-blind, and placebo-controlled trial with two parallel arms: an intervention group using silver diamine fluoride (SDF) and a placebo group (control). 60 eligible healthy adults will be enrolled in the study and randomly assigned to one of the two treatment groups. Both groups will receive the traditional preventive measures including cleanings, Fluoride varnish, diet analysis and counseling. Study participants will be followed for one year and caries progression will be radiographically monitored.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

October 28, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

January 7, 2016

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
9 months until next milestone

Results Posted

Study results publicly available

March 14, 2023

Completed
Last Updated

March 14, 2023

Status Verified

February 1, 2023

Enrollment Period

5.6 years

First QC Date

October 28, 2015

Results QC Date

February 20, 2023

Last Update Submit

February 20, 2023

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • Assessment of Radiographic Change in Dental Cavity

    Determine if there is a change in the size of the dental cavity from baseline to 12 months after blinded treatment with either Silver Diamine Fluoride 38% or placebo (sterile water). This measurement will be assessed using radiographic examination to determine if there is either evidence of no radiographic change, radiographic progression, or radiographic regression.

    Baseline, 12 months after blinded treatment with either Silver Diamine Fluoride 38% or placebo (sterile water)

Study Arms (2)

Silver Diamine Fluoride 38%

ACTIVE COMPARATOR

Group 1 (SDF 38%) will receive the application of silver diammine fluoride (38% SDF solution) in addition to 5% sodium fluoride varnish to each approximal carious lesion (scores RA1,RA2,RA3) in a posterior tooth (premolar or molar) that is in contact with an adjacent tooth, using super floss, for a duration of 3 minutes under rubber dam isolation.

Device: Silver Diamine Fluoride 38%

Placebo (Sterile water)

PLACEBO COMPARATOR

Group 2 Placebo (control) will receive the application of sterile water (placebo) in addition to 5% sodium fluoride varnish to each approximal carious lesion (scores RA1,RA2,RA3) in a posterior tooth (premolar or molar) that is in contact with an adjacent tooth, using super floss, for a duration of 3 minutes under rubber dam isolation.

Device: Group 2 (Placebo)

Interventions

Silver Diamine Fluoride 38%DEVICE

Group 1 (SDF group) subjects will receive the application of silver diamine fluoride (38% SDF solution) in addition to 5% Fluoride varnish to each approximal incipiency, using super floss, for a duration of 3 minutes under rubber dam isolation.

Also known as: 38% SDF
Silver Diamine Fluoride 38%
Group 2 (Placebo)DEVICE

Group 2 (Placebo) subjects will receive application of sterile water (placebo) in addition to 5% Fluoride varnish to each approximal incipiency, using super floss, for a duration of 3 minutes under rubber dam isolation.

Also known as: Sterile Water
Placebo (Sterile water)

Eligibility Criteria

Age21 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Presence of at least one approximal caries lesion (scores RA1, RA2, RA3 according to the ICCMS radiographic scoring system) in one of the posterior teeth (premolars and molars) presented with full contact with the adjacent tooth.
  • All the surfaces eligible for this study will be included.

You may not qualify if:

  • The approximal lesion detected in the radiograph has advanced dentine lesion (RB4, RC5, or RC6)
  • or is adjacent to a lesion that is either filled or will receive a filling at the time of enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (7)

  • Rosenblatt A, Stamford TC, Niederman R. Silver diamine fluoride: a caries "silver-fluoride bullet". J Dent Res. 2009 Feb;88(2):116-25. doi: 10.1177/0022034508329406.

    PMID: 19278981BACKGROUND

  • Santos VE Jr, Vasconcelos Filho A, Targino AG, Flores MA, Galembeck A, Caldas AF Jr, Rosenblatt A. A new "silver-bullet" to treat caries in children--nano silver fluoride: a randomised clinical trial. J Dent. 2014 Aug;42(8):945-51. doi: 10.1016/j.jdent.2014.05.017. Epub 2014 Jun 12.

    PMID: 24930870BACKGROUND

  • 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

  • Mattos-Silveira J, Floriano I, Ferreira FR, Vigano ME, Frizzo MA, Reyes A, Novaes TF, Moriyama CM, Raggio DP, Imparato JC, Mendes FM, Braga MM. New proposal of silver diamine fluoride use in arresting approximal caries: study protocol for a randomized controlled trial. Trials. 2014 Nov 19;15:448. doi: 10.1186/1745-6215-15-448.

    PMID: 25409545BACKGROUND

  • Tellez M, Gomez J, Kaur S, Pretty IA, Ellwood R, Ismail AI. Non-surgical management methods of noncavitated carious lesions. Community Dent Oral Epidemiol. 2013 Feb;41(1):79-96. doi: 10.1111/cdoe.12028.

    PMID: 23253076BACKGROUND

  • Llodra JC, Rodriguez A, Ferrer B, Menardia V, Ramos T, Morato M. Efficacy of silver diamine fluoride for caries reduction in primary teeth and first permanent molars of schoolchildren: 36-month clinical trial. J Dent Res. 2005 Aug;84(8):721-4. doi: 10.1177/154405910508400807.

    PMID: 16040729BACKGROUND

  • Ekstrand KR, Bruun G, Bruun M. Plaque and gingival status as indicators for caries progression on approximal surfaces. Caries Res. 1998;32(1):41-5. doi: 10.1159/000016428.

    PMID: 9438570BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Results Point of Contact

Title
Dr. Justine Kolker
Organization
University of Iowa College of Dentistry
justine-kolker@uiowa.edu
(319) 335-7583

Study Officials

  • Michael Kanellis, DDS, MS

    University of Iowa

    PRINCIPAL INVESTIGATOR

  • Justine Kolker, DDS, MS

    University of Iowa

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 28, 2015

First Posted

October 29, 2015

Study Start

January 7, 2016

Primary Completion

August 1, 2021

Study Completion

June 30, 2022

Last Updated

March 14, 2023

Results First Posted

March 14, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)