CClinicalTrials.gg
Status unknownNCT03185104Updated Jun 14, 2017

Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers

An interventional study of Silver Diamine Fluoride and Distilled Water in Dental Caries and Dental Caries of Root Surface, sponsored by The University of Hong Kong. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-14.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
196
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dental Caries
  • Dental Caries of Root Surface

Keywords

  • removable partial denture
  • silver diamine fluoride
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
196 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugSilver 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.

    Also known as: Saforide

  • DrugDistilled Water

    Distilled water is applied to the dried and exposed coronal and root surfaces of all teeth by means of a disposable microbrush.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 36 months

Secondary outcomes

  1. 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.

    Time frame: 36 months

  2. 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.

    Time frame: 36 months

  3. 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.

    Time frame: 36 months

  4. 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.

    Time frame: 36 months

  5. 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.

    Time frame: 36 months

  6. 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.

    Time frame: 36 months

  7. 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.

    Time frame: 36 months

  8. Colonization of lactobacilli in saliva

    The count of lactobacilli in SWS is recorded. The count of lactobacilli in SWS is expressed as cfu/ml.

    Time frame: 36 months

  9. 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.

    Time frame: 36 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03185104
Lead sponsor
The University of Hong Kong
Responsible party
Sponsor
First posted
Jun 14, 2017
Start date
Nov 1, 2013
Primary completion
Jun 30, 2017 (estimated)
Completion
Dec 31, 2017 (estimated)
Last update
Jun 14, 2017

Study contacts

Katherine CM Leung, BDS,MDS, PhD
principal investigator · Faculty of Dentistry, The University of Hong Kong

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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