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The goal of this 36-month double-blind randomized controlled trial is to compare the effects of 5% sodium fluoride varnish (22,600 ppm fluoride) with or without Strontium-doped bioactive glass (SBGC) on root caries development in community-dwelling older adults.
This 36-month, double-blind, two-arm randomized controlled trial is aimed to compare the effects of 5% sodium fluoride varnish (22,600 ppm fluoride) with or without Strontium-doped bioactive glass (SBGC) on root caries development in community-dwelling older adults.
Participants will be divided in to two groups, The main question it aims to answer is: Is fluoride varnish with SBGC more effective than that without SBGC on prevention root caries in community-dwelling older adults? Participants will be divided into two groups, experimental group and controlled group after randomization. Subjects in the experimental group will receive fluoride varnish with SBGC quarterly, and subjects in the controlled group will receive fluoride varnish without SBGC quarterly.
It is hypothesized that community-dwelling older adults who receive quarterly fluoride varnish applications containing SBGC will develop fewer root caries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoride varnish with SBGC | Experimental | This group will receive applications of fluoride varnish (containing 5% NaF) with 7.5% SBGC every 3 months for 36 months. |
|
| Fluoride varnish without SBGC | Active Comparator | This group will receive 5% NaF varnish with SBGC every 3 months for 36 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride varnish with SBGC | Combination Product | The Fluoride varnish (containing 5% NaF, Duraphat®, Colgate-Palmolive Company, NY, USA) mixed with 7.5% SBGC (Dencare (Chongqing) Oral Care Co., Ltd). |
| Measure | Description | Time Frame |
|---|---|---|
| New root caries lesions and restorations | All exposed root surfaces will be examined for new caries lesions based on the ICDAS criteria. Restorations due to root caries will also be recorded after confirmation with the subjects. | Baseline, 12, 24, 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Arrested root caries | An active root caries lesion found at baseline changed into inactive at follow-ups, according to ICDAS II criteria. | Baseline, 12, 24, 36 months |
| Satisfaction of the use of varnish |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine CM Leung, BDS,MDS,PhD | Faculty of Dentistry, The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center, the Prince Philips Dental Hospital | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D017213 | Root Caries |
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C023807 | sodium fluoride topical preparation |
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Participants are randomized assigned to either experimental group or controlled group.
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The subjects and the clinical team including the dentist and the dental surgery assistant will all be blinded to the subjects' assignment of the intervention.
| Fluoride varnish | Drug | The Fluoride varnish (containing 5% NaF, Duraphat®, Colgate-Palmolive Company, NY, USA) |
|
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Investigated by survey.
| 12, 24, 36 months |