Dental CariesPhase 2/3NCT02742142
Fluoride Application on Preventing and Arresting Root Caries in Fluoridated and Non-fluoridated Areas
A Phase 2/3 study testing silver diammine fluoride in people with Dental Caries, run by The University of Hong Kong at 2 sites in China.
Trial summary
This study was a randomized clinical trial lasting for 24 months in two study sites, Hong Kong (water fluoridated) and Guangzhou (non-fluoridated area). A total of 534 subjects will be recruited from elderly social centers located in different districts in the two study sites (260 \& 274). Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- silver diammine fluoride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 534 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2012to Dec 2015
- Phase
- Phase 2/3
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- have at least 5 teeth with exposed root surfaces and not indicated for extraction, and
- living in the community and have self-care ability for normal daily activities.
Who cannot join
- have life-threatening or serious health problems,
- have cognitive problems in communication or in receiving oral hygiene instructions
- have salivary gland diseases or received radiotherapy in the head and neck region.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Sun Yat-sen University
Guangzhou, Guangdong
The University of Hong Kong
Hong Kong
About this study
Official title: Randomized Clinical Trial on Preventing and Arresting Root Surface Caries Using Silver Diammine Fluoride Solution in Older Adults Living in Fluoridated and Non-fluoridated Areas
This study was a randomized clinical trial lasting for 24 months in two study sites, Hong Kong (water fluoridated) and Guangzhou (non-fluoridated area). A total of 534 subjects will be recruited from elderly social centers located in different districts in the two study sites (260 \& 274). Baseline clinical examination was conducted by a single calibrated examiner in the social centers using an intra-oral LED light, mouth mirrors and probes. Subjects were randomly allocated into two study groups and receive interventions accordingly. Follow-up examinations at 6-month intervals were carried out to assess the clinical outcomes, i.e. whether new root caries developed and whether the active root caries found at baseline become arrested. Results of this study could provide the much needed evidence to guide the dental professionals in Hong Kong and China, and possibly worldwide in deciding on the most appropriate intervention for the prevention and management of this common dental disease of the older adults.
Read the detailed description
The primary and secondary outcome of this study was new root caries and arrested root caries. A root surface with new caries experience was recorded when a root surface which was sound at baseline was found to have a carious lesion or a filling at a follow-up examination. Arrested root caries was recorded when the active root caries found at baseline changed into inactive root caries at follow-up. The status of each root surface was recorded using the codes recommended by the International Caries Detection and Assessment System (ICDAS Ⅱ) Coordinating Committee in 2009.
A mean root caries increment of around 0.8 root surface per year of control group was reported in a previous clinical trial conducted in Hong Kong. Thus, in this study, a 24-month increment of 1.6 new decayed root surfaces and a standard deviation of 2 was anticipated. In order to show that a 50% difference in mean caries increment between the test and control groups was statistically significant using a 2-sample t-test at a 5% significance level and at an 80% power, a sample size of 100 subjects in each group was required. Allowing for a drop-out rate of 20% over 24 months, a total of 480 subjects (120 in each group each site) were needed.
- Conditions
- Dental Caries
- Being tested
- water as placebo, silver diammine fluoride
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water as placeboOther
Also called water
topical application of water as a placebo in the control arm
silver diammine fluorideDrug
Also called SDF
topical application of the SDF solution onto tooth root surfaces
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | Distilled water as placebo with a bitter flavor added (to mimic the bitter metallic taste of SDF) was painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.In addition, instructions on oral hygiene (OHI) tailored to the individual's condition was given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) was provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. Receives: Other: water as placebo |
| silver diammine fluoride | Experimental | the subjects received the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution was painted onto the exposed tooth root surfaces. This treatment was repeated after 12 and 24 months. Receives: Drug: silver diammine fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth Root Caries Lesions
Tooth roots that have changed from sound at baseline to decayed at the evaluation examination will be counted in the clinical examination
Measured: 24 months
Secondary outcomes (1)
Arrested root caries lesions
Active tooth root caries lesions at baseline that has changed to inactive root caries lesions at the evaluation examination
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startOct 2012
- Primary completionDec 2015
- Study completionDec 2015
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University
- Responsible party
- Sponsor
- Investigators
- Edward CM Lo, BDS, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742142
- Sponsor's protocol ID
- UW12-296
- Status last verified
- Apr 2016
- First submitted
- 13 Apr 2016
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Will consider individual request case by case
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial on Preventing and Arresting Root Surface Caries Using Silver Diammine Fluoride Solution in Older Adults Living in Fluoridated and Non-fluoridated Areas
- ClinicalTrials.gov ID
- NCT02742142
- Acronym / sponsor ID
- UW12-296
- Conditions
- Dental Caries
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Sun Yat-sen University
- Study start
- Oct 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Apr 2016 (estimated)
- 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 was a randomized clinical trial lasting for 24 months in two study sites, Hong Kong (water fluoridated) and Guangzhou (non-fluoridated area). A total of 534 subjects will be recruited from elderly social centers located in different districts in the two study sites (260 \& 274). Baseline clinical examination was conducted by a single calibrated examiner in the social centers using an intra-oral LED light, mouth mirrors and probes. Subjects were randomly allocated into two study groups and receive interventions accordingly. Follow-up examinations at 6-month intervals were carried out to assess the clinical outcomes, i.e. whether new root caries developed and whether the active root caries found at baseline become arrested. Results of this study could provide the much needed evidence to guide the dental professionals in Hong Kong and China, and possibly worldwide in deciding on the most appropriate intervention for the prevention and management of this common dental disease of the older adults.
Detailed description
The primary and secondary outcome of this study was new root caries and arrested root caries. A root surface with new caries experience was recorded when a root surface which was sound at baseline was found to have a carious lesion or a filling at a follow-up examination. Arrested root caries was recorded when the active root caries found at baseline changed into inactive root caries at follow-up. The status of each root surface was recorded using the codes recommended by the International Caries Detection and Assessment System (ICDAS Ⅱ) Coordinating Committee in 2009.
A mean root caries increment of around 0.8 root surface per year of control group was reported in a previous clinical trial conducted in Hong Kong. Thus, in this study, a 24-month increment of 1.6 new decayed root surfaces and a standard deviation of 2 was anticipated. In order to show that a 50% difference in mean caries increment between the test and control groups was statistically significant using a 2-sample t-test at a 5% significance level and at an 80% power, a sample size of 100 subjects in each group was required. Allowing for a drop-out rate of 20% over 24 months, a total of 480 subjects (120 in each group each site) were needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Other: water as placeboDistilled water as placebo with a bitter flavor added (to mimic the bitter metallic taste of SDF) was painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.In addition, instructions on oral hygiene (OHI) tailored to the individual's condition was given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) was provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. |
| silver diammine fluoride | Experimental | Drug: silver diammine fluoridethe subjects received the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution was painted onto the exposed tooth root surfaces. This treatment was repeated after 12 and 24 months. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- have at least 5 teeth with exposed root surfaces and not indicated for extraction, and
- living in the community and have self-care ability for normal daily activities.
Key exclusion criteria (3 listed)
- have life-threatening or serious health problems,
- have cognitive problems in communication or in receiving oral hygiene instructions
- have salivary gland diseases or received radiotherapy in the head and neck region.
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 |
|---|---|---|
| water as placeboAlso: watertopical application of water as a placebo in the control arm | Other | control |
| silver diammine fluorideAlso: SDFtopical application of the SDF solution onto tooth root surfaces | Drug | silver diammine fluoride |
Primary outcome
Tooth Root Caries Lesions
Time frame: 24 months
Tooth roots that have changed from sound at baseline to decayed at the evaluation examination will be counted in the clinical examination
1 secondary outcome
Arrested root caries lesions
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
- Individual participant dataSharing planned: No. Will consider individual request case by case
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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.
Edward CM Lo, BDS, PhD principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing silver diammine fluoride in people with Dental Caries, run by The University of Hong Kong at 2 sites in China.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tooth Root Caries Lesions (time frame: 24 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 18 Apr 2016.