Fluoride Application on Preventing and Arresting Root Caries in Fluoridated and Non-fluoridated Areas

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Dental Caries

Intervention / Treatment
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* Other: water as placebo
* Drug: silver diammine fluoride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br>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. | Other: water as placebo<br>* topical application of water as a placebo in the control arm<br>* Other names: water;|
| Experimental: silver diammine fluoride<br>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. | Drug: silver diammine fluoride<br>* topical application of the SDF solution onto tooth root surfaces<br>* Other names: SDF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrested root caries lesions | Active tooth root caries lesions at baseline that has changed to inactive root caries lesions at the evaluation examination | 24 months |