Dental CariesNCT03185104
Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers
A study testing Silver Diamine Fluoride and Distilled Water in people with Dental Caries and Dental Caries of Root Surface, run by The University of Hong Kong.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Caries, Dental Caries of Root Surface
- What is being tested?
- Silver Diamine Fluoride and Distilled Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2013to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are wearing removable partial dentures constructed by staff or students at the Prince Philip Dental Hospital are recruited
Who cannot join
- 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.
About this study
Official title: Randomized Double-blind Placebo-controlled Trial of Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers
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.
- Conditions
- Dental Caries, Dental Caries of Root Surface
- Being tested
- Silver Diamine Fluoride, Distilled Water
- Keywords
- removable partial denture, silver diamine fluoride
- Medical subject headings
- Dental Caries, Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Diamine FluorideDrug
Also called Saforide
Silver diamine fluoride solution is applied to the dried and exposed coronal and root surfaces of all teeth by means of a disposable microbrush.
Distilled WaterDrug
Distilled water is applied to the dried and exposed coronal and root surfaces of all teeth by means of a disposable microbrush.
| Study group | Role | What they receive |
|---|---|---|
| Silver diamine fluoride | Experimental | 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. Receives: Drug: Silver Diamine Fluoride |
| Distilled water | Placebo comparator | Distilled water is professionally applied to exposed coronal and root surfaces of all teeth every 6 months for 36 months. Receives: Drug: Distilled Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (9)
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.
Measured: 36 months
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.
Measured: 36 months
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.
Measured: 36 months
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.
Measured: 36 months
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.
Measured: 36 months
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.
Measured: 36 months
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.
Measured: 36 months
Colonization of lactobacilli in saliva
The count of lactobacilli in SWS is recorded. The count of lactobacilli in SWS is expressed as cfu/ml.
Measured: 36 months
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start1 Nov 2013
- Primary completion30 Jun 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine CM Leung, BDS,MDS, PhD, Principal investigator, Faculty of Dentistry, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185104
- Sponsor's protocol ID
- SDF RPD wearers
- Status last verified
- Jun 2017
- First submitted
- 24 Apr 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Placebo-controlled Trial of Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers
- ClinicalTrials.gov ID
- NCT03185104
- Acronym / sponsor ID
- SDF RPD wearers
- Conditions
- Dental Caries, Dental Caries of Root Surface
- Keywords
- removable partial denture, silver diamine fluoride
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 30 Jun 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Silver diamine fluoride | Experimental | Drug: Silver Diamine Fluoride38% 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 | Placebo comparator | Drug: Distilled WaterDistilled water is professionally applied to exposed coronal and root surfaces of all teeth every 6 months for 36 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are wearing removable partial dentures constructed by staff or students at the Prince Philip Dental Hospital are recruited
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silver Diamine FluorideAlso: SaforideSilver diamine fluoride solution is applied to the dried and exposed coronal and root surfaces of all teeth by means of a disposable microbrush. | Drug | Silver diamine fluoride |
| Distilled WaterDistilled water is applied to the dried and exposed coronal and root surfaces of all teeth by means of a disposable microbrush. | Drug | Distilled water |
Primary outcome
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.
9 secondary outcomes
Prevalence of oral colonization of oral yeasts
Time frame: 36 months
Colonization of oral yeasts in oral rinse
Time frame: 36 months
Colonization of oral yeasts in dental plaque
Time frame: 36 months
Prevalence of oral colonization of Streptococcus mutans (S. mutans)
Time frame: 36 months
Colonization of S. mutans in saliva
Time frame: 36 months
Colonization of S. mutans in dental plaque
Time frame: 36 months
Prevalence of oral colonization of lactobacilli
Time frame: 36 months
Colonization of lactobacilli in saliva
Time frame: 36 months
Colonization of lactobacilli in dental plaque
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine CM Leung, BDS,MDS, PhD principal investigator
Faculty of Dentistry, The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Silver Diamine Fluoride and Distilled Water in people with Dental Caries and Dental Caries of Root Surface, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries increment (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.