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Completed

NCT Number: NCT02591147

Silver Diamine Fluoride Pilot Study (SDF)

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.

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Key information

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: 38% SDF

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.

Other names: Sterile Water

Primary outcomes

  1. Assessment of Radiographic Change in Dental Cavity

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

    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.

Sponsors and collaborators

Lead sponsor

Justine Kolker

Other

Registry information

Official study title

Effectiveness of Silver Diamine Fluoride in Arresting Early Approximal Carious Lesion Progression: A Pilot Study

Acronym: SDF

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Oct 29, 2015
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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