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Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers

Primary Purpose

Dental Caries, Dental Caries of Root Surface

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Silver Diamine Fluoride
Distilled Water
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring removable partial denture, silver diamine fluoride

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who are wearing removable partial dentures constructed by staff or students at the Prince Philip Dental Hospital are recruited

Exclusion Criteria:

  • If they have less than 4 teeth in any dental arch, have advanced periodontal disease in 2 or more sextants, have received therapeutic radiation of the head and neck region, have concurrent systemic illness that alters salivary flow, or have participated in a clinical trial within 6 months before the commencement of participation in this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Silver diamine fluoride

    Distilled water

    Arm Description

    38% silver diamine fluoride solution (Saforide, Toyo Seiyaku Kasei Co. Ltd., Osaka, Japan) is professionally applied to exposed coronal and root surfaces of all teeth every 6 months for 36 months.

    Distilled water is professionally applied to exposed coronal and root surfaces of all teeth every 6 months for 36 months.

    Outcomes

    Primary Outcome Measures

    Caries increment
    New and recurrent caries lesions are recorded according to the International Caries Detection and Assessment System (ICDAS). Molars and premolars are considered to have 5 coronal surfaces, whereas canines and incisors are considered to have 4. The cleaned and dried teeth are recorded as sound, sealed, restored, crowned, or missing. Each coronal tooth surface is classified using a 7-point ordinal scale ranging from sound to extensive cavitation using a WHO probe. The same procedure is repeated for all root surfaces. Coronal and root surface caries increments are calculated by comparing the baseline and follow-up observations for each tooth surface.

    Secondary Outcome Measures

    Prevalence of oral colonization of oral yeasts
    The prevalence of oral yeast in oral rinse and dental plaque is counted. Prevalence is expressed as percentage of the participants.
    Colonization of oral yeasts in oral rinse
    The count of oral yeasts in oral rinse is recorded. The count of oral yeast in oral rinse is expressed as colony-forming unit (cfu)/ml.
    Colonization of oral yeasts in dental plaque
    The count of oral yeasts in dental plaque is recorded. The count of oral yeast in dental plaque is expressed as cfu/g.
    Prevalence of oral colonization of Streptococcus mutans (S. mutans)
    The prevalence S. mutans in stimulated whole saliva (SWS) and dental plaque is counted. Prevalence is expressed as percentage of the participants.
    Colonization of S. mutans in saliva
    The count of S. mutans in SWS is recorded. The count of S. mutans in SWS is expressed as cfu/ml.
    Colonization of S. mutans in dental plaque
    The count of S. mutans dental plaque is recorded. The count of S. mutans in dental plaque is expressed as cfu/g.
    Prevalence of oral colonization of lactobacilli
    The prevalence of lactobacilli in SWS and dental plaque is counted. Prevalence is expressed as percentage of the participants.
    Colonization of lactobacilli in saliva
    The count of lactobacilli in SWS is recorded. The count of lactobacilli in SWS is expressed as cfu/ml.
    Colonization of lactobacilli in dental plaque
    The count of lactobacilli in dental plaque is recorded. The count of lactobacilli in dental plaque is expressed as cfu/g.

    Full Information

    First Posted
    April 24, 2017
    Last Updated
    June 9, 2017
    Sponsor
    The University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03185104
    Brief Title
    Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers
    Official Title
    Randomized Double-blind Placebo-controlled Trial of Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2013 (Actual)
    Primary Completion Date
    June 30, 2017 (Anticipated)
    Study Completion Date
    December 31, 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study measures and compares the effect of silver diamine fluoride (SDF) on caries increment in removable partial denture wearers. Half of the participants will SDF and while the other half will receive placebo.
    Detailed Description
    Removable partial dentures are commonly constructed to replace missing teeth. It is observed that removable partial denture wearers are susceptible to dental caries. The mode of action of silver diamine fluoride on caries prevention is dual: fluoride ions interact synergistically with silver to react with hydroxyapatite to form fluorapatite, and silver is bactericidal by reacting with the thiol groups of the amino and nucleic acids that halt the metabolic and reproductive functions of the cariogenic bacteria.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries, Dental Caries of Root Surface
    Keywords
    removable partial denture, silver diamine fluoride

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Removable partial denture wearers are randomized assigned to either the fluoride group or the placebo group. The fluoride group receives semi-annually professionally applied 38% SDF solution to all exposed tooth and root surfaces while the placebo group receives distilled water using the same application method.
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    Application of the SDF/placebo is conducted by a dentist who is not involved in the clinical data collection.
    Allocation
    Randomized
    Enrollment
    196 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Silver diamine fluoride
    Arm Type
    Experimental
    Arm Description
    38% silver diamine fluoride solution (Saforide, Toyo Seiyaku Kasei Co. Ltd., Osaka, Japan) is professionally applied to exposed coronal and root surfaces of all teeth every 6 months for 36 months.
    Arm Title
    Distilled water
    Arm Type
    Placebo Comparator
    Arm Description
    Distilled water is professionally applied to exposed coronal and root surfaces of all teeth every 6 months for 36 months.
    Intervention Type
    Drug
    Intervention Name(s)
    Silver Diamine Fluoride
    Other Intervention Name(s)
    Saforide
    Intervention Description
    Silver diamine fluoride solution is applied to the dried and exposed coronal and root surfaces of all teeth by means of a disposable microbrush.
    Intervention Type
    Drug
    Intervention Name(s)
    Distilled Water
    Intervention Description
    Distilled water is applied to the dried and exposed coronal and root surfaces of all teeth by means of a disposable microbrush.
    Primary Outcome Measure Information:
    Title
    Caries increment
    Description
    New and recurrent caries lesions are recorded according to the International Caries Detection and Assessment System (ICDAS). Molars and premolars are considered to have 5 coronal surfaces, whereas canines and incisors are considered to have 4. The cleaned and dried teeth are recorded as sound, sealed, restored, crowned, or missing. Each coronal tooth surface is classified using a 7-point ordinal scale ranging from sound to extensive cavitation using a WHO probe. The same procedure is repeated for all root surfaces. Coronal and root surface caries increments are calculated by comparing the baseline and follow-up observations for each tooth surface.
    Time Frame
    36 months
    Secondary Outcome Measure Information:
    Title
    Prevalence of oral colonization of oral yeasts
    Description
    The prevalence of oral yeast in oral rinse and dental plaque is counted. Prevalence is expressed as percentage of the participants.
    Time Frame
    36 months
    Title
    Colonization of oral yeasts in oral rinse
    Description
    The count of oral yeasts in oral rinse is recorded. The count of oral yeast in oral rinse is expressed as colony-forming unit (cfu)/ml.
    Time Frame
    36 months
    Title
    Colonization of oral yeasts in dental plaque
    Description
    The count of oral yeasts in dental plaque is recorded. The count of oral yeast in dental plaque is expressed as cfu/g.
    Time Frame
    36 months
    Title
    Prevalence of oral colonization of Streptococcus mutans (S. mutans)
    Description
    The prevalence S. mutans in stimulated whole saliva (SWS) and dental plaque is counted. Prevalence is expressed as percentage of the participants.
    Time Frame
    36 months
    Title
    Colonization of S. mutans in saliva
    Description
    The count of S. mutans in SWS is recorded. The count of S. mutans in SWS is expressed as cfu/ml.
    Time Frame
    36 months
    Title
    Colonization of S. mutans in dental plaque
    Description
    The count of S. mutans dental plaque is recorded. The count of S. mutans in dental plaque is expressed as cfu/g.
    Time Frame
    36 months
    Title
    Prevalence of oral colonization of lactobacilli
    Description
    The prevalence of lactobacilli in SWS and dental plaque is counted. Prevalence is expressed as percentage of the participants.
    Time Frame
    36 months
    Title
    Colonization of lactobacilli in saliva
    Description
    The count of lactobacilli in SWS is recorded. The count of lactobacilli in SWS is expressed as cfu/ml.
    Time Frame
    36 months
    Title
    Colonization of lactobacilli in dental plaque
    Description
    The count of lactobacilli in dental plaque is recorded. The count of lactobacilli in dental plaque is expressed as cfu/g.
    Time Frame
    36 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who are wearing removable partial dentures constructed by staff or students at the Prince Philip Dental Hospital are recruited Exclusion Criteria: If they have less than 4 teeth in any dental arch, have advanced periodontal disease in 2 or more sextants, have received therapeutic radiation of the head and neck region, have concurrent systemic illness that alters salivary flow, or have participated in a clinical trial within 6 months before the commencement of participation in this study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Katherine CM Leung, BDS,MDS, PhD
    Organizational Affiliation
    Faculty of Dentistry, The University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers

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