Dental Caries of Root Surface, Root Caries
Conditions
Keywords
Strontium-doped Bioactive Glass Ceramic, Fluoride varnish, Older adults, Root caries, Dentine, Prevention
Brief summary
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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTFluoride varnish with SBGC
The Fluoride varnish (containing 5% NaF, Duraphat®, Colgate-Palmolive Company, NY, USA) mixed with 7.5% SBGC (Dencare (Chongqing) Oral Care Co., Ltd).
DRUGFluoride varnish
The Fluoride varnish (containing 5% NaF, Duraphat®, Colgate-Palmolive Company, NY, USA)
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
Participants are randomized assigned to either experimental group or controlled group.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult \> 60 years old * good collaborative relationships
Exclusion criteria
* less than 8 natural teeth * have severe medical conditions * are in use of high fluoride toothpaste
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New root caries lesions and restorations | Baseline, 12, 24, 36 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arrested root caries | Baseline, 12, 24, 36 months | An active root caries lesion found at baseline changed into inactive at follow-ups, according to ICDAS II criteria. |
| Satisfaction of the use of varnish | 12, 24, 36 months | Investigated by survey. |
Countries
Hong Kong
Contacts
PRINCIPAL_INVESTIGATORKatherine CM Leung, BDS,MDS,PhD
Faculty of Dentistry, The University of Hong Kong
Outcome results
None listed