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Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers

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ClinicalTrials.gov Identifier: NCT03185104
Recruitment Status : Active, not recruiting
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Dental Caries Dental Caries of Root Surface Drug: Silver Diamine Fluoride Drug: Distilled Water Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Application of the SDF/placebo is conducted by a dentist who is not involved in the clinical data collection.
Primary Purpose: Prevention
Official Title: Randomized Double-blind Placebo-controlled Trial of Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers
Actual Study Start Date : November 1, 2013
Estimated Primary Completion Date : June 30, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arm Intervention/treatment
Experimental: Silver diamine fluoride
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.
Drug: Silver Diamine Fluoride
Silver diamine fluoride solution is applied to the dried and exposed coronal and root surfaces of all teeth by means of a disposable microbrush.
Other Name: Saforide

Placebo Comparator: Distilled water
Distilled water is professionally applied to exposed coronal and root surfaces of all teeth every 6 months for 36 months.
Drug: Distilled Water
Distilled water is applied to the dried and exposed coronal and root surfaces of all teeth by means of a disposable microbrush.




Primary Outcome Measures :
  1. Caries increment [ Time Frame: 36 months ]
    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 :
  1. Prevalence of oral colonization of oral yeasts [ Time Frame: 36 months ]
    The prevalence of oral yeast in oral rinse and dental plaque is counted. Prevalence is expressed as percentage of the participants.

  2. Colonization of oral yeasts in oral rinse [ Time Frame: 36 months ]
    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.

  3. Colonization of oral yeasts in dental plaque [ Time Frame: 36 months ]
    The count of oral yeasts in dental plaque is recorded. The count of oral yeast in dental plaque is expressed as cfu/g.

  4. Prevalence of oral colonization of Streptococcus mutans (S. mutans) [ Time Frame: 36 months ]
    The prevalence S. mutans in stimulated whole saliva (SWS) and dental plaque is counted. Prevalence is expressed as percentage of the participants.

  5. Colonization of S. mutans in saliva [ Time Frame: 36 months ]
    The count of S. mutans in SWS is recorded. The count of S. mutans in SWS is expressed as cfu/ml.

  6. Colonization of S. mutans in dental plaque [ Time Frame: 36 months ]
    The count of S. mutans dental plaque is recorded. The count of S. mutans in dental plaque is expressed as cfu/g.

  7. Prevalence of oral colonization of lactobacilli [ Time Frame: 36 months ]
    The prevalence of lactobacilli in SWS and dental plaque is counted. Prevalence is expressed as percentage of the participants.

  8. Colonization of lactobacilli in saliva [ Time Frame: 36 months ]
    The count of lactobacilli in SWS is recorded. The count of lactobacilli in SWS is expressed as cfu/ml.

  9. Colonization of lactobacilli in dental plaque [ Time Frame: 36 months ]
    The count of lactobacilli in dental plaque is recorded. The count of lactobacilli in dental plaque is expressed as cfu/g.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185104


Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Katherine CM Leung, BDS,MDS, PhD Faculty of Dentistry, The University of Hong Kong

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Study protocol can be downloaded from this web site.

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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03185104     History of Changes
Other Study ID Numbers: SDF RPD wearers
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The University of Hong Kong:
removable partial denture
silver diamine fluoride

Additional relevant MeSH terms:
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Dental Caries
Root Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs