Silver Diamine Fluoride Pilot Study (SDF)

Sponsor
Justine Kolker (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02591147
Collaborator
(none)
55
1
2
77.7
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Silver Diamine Fluoride 38%
  • Device: Group 2 (Placebo)
N/A

Detailed Description

This pilot study will compare 1) Silver diamine fluoride (SDF) and fluoride varnish to 2) Placebo and fluoride varnish (conventional prevention) in the management of early approximal carious lesions. Early approximal carious lesions refers to decay between teeth, diagnosed with radiographs, not extending more than 1/3 of the way into dentin. Management of early approximal carious lesions refers to halting lesion progression, or encouraging lesion reversal after an early carious lesion is detected.

SDF provides a novel, low-cost intervention option for managing early carious lesions that could potentially bridge the 'gap' between non-operative and operative options; thus, postponing the first placement of a restoration. SDF has been used in arresting carious lesions for more than 100 years. However, SDF has never been tested in the arrest of approximal caries lesions in permanent teeth.

SDF acts to both prevent and arrest tooth decay in multiple ways: 1) it acts on the body of carious lesions by precipitating silver ion into the lesion, thus blocking diffusion pathways for cariogenic acids; 2) it interacts with dental enamel leading to the formation of fluoroapatite crystals making the tooth surface more acid resistant; and 3) the precipitated silver from SDF acts as a bactericidal agent disturbing the formation of cariogenic biofilm.

Study Design

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Health Services Research
Official Title:
Effectiveness of Silver Diamine Fluoride in Arresting Early Approximal Carious Lesion Progression: A Pilot Study
Actual Study Start Date :
Jan 7, 2016
Actual Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Silver Diamine Fluoride 38%

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%
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.
Other Names:
  • 38% SDF
  • Placebo Comparator: Placebo (Sterile water)

    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)
    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.
    Other Names:
  • Sterile Water
  • Outcome Measures

    Primary Outcome Measures

    1. Caries Progression [12 months]

      comparison of radiographs to determine if there is caries progression in the subjects approximal lesions based on the radiographic examination.

    Secondary Outcome Measures

    1. Incidence of caries in all other teeth in the study subject [12 months]

      Count for new carious lesions developing over the course of the study period to assess the effect of SDF on preventing the development of early carious lesions

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 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.

    Exclusion Criteria:
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Iowa Iowa City Iowa United States 52242

    Sponsors and Collaborators

    • Justine Kolker

    Investigators

    • Principal Investigator: Michael Kanellis, DDS, MS, University of Iowa
    • Principal Investigator: Justine Kolker, DDS, MS, University of Iowa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Justine Kolker, Principal Investigator, University of Iowa
    ClinicalTrials.gov Identifier:
    NCT02591147
    Other Study ID Numbers:
    • 201509831
    First Posted:
    Oct 29, 2015
    Last Update Posted:
    Dec 28, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 28, 2021