Dental Caries
Conditions
Keywords
tooth decay, fluoride, sealant, prevention
Brief summary
Nearly half of the 12-year-old children in China have dental caries (tooth decay) and most of the lesions are in the fissures of the first permanent molars. This study aims to investigate the effectiveness of three methods in preventing fissure caries in permanent teeth in Chinese children, namely resin fissure sealant, sodium fluoride varnish, and silver diamine fluoride solution. The cost-effectiveness of these methods will also be compared. About 400 children, aged 8 to 9 years, will be recruited. Clinical examination of the children will be conducted in school using portable dental lights and instruments to identify teeth that need caries prevention. The children will be randomly allocated to one of the three test or the control groups. Treatments will be provided in the study primary schools according to standard clinical protocols. Follow-up examinations will be carried out every six months for 30 months to assess whether the preventive methods are successful, i.e. no dental caries develops in the treated teeth. The findings of this study will be of great value to dentists and public health authorities in deciding on the most appropriate dental caries prevention programme for school children in China and other developing countries.
Interventions
OTHERplacement of fissure sealant
placement of resin-based fissure sealant at baseline without replacement
OTHERfluoride varnish
topical applications of a 5% sodium fluoride (NaF) varnish onto tooth surface every 6 months
OTHERsilver fluoride
topical applications of a 38% silver diamine fluoride (SDF) solution onto tooth surface every year
OTHERplacebo control
application of water onto tooth surface every year
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* school children in good general health * have at least one permanent first molars that has deep occlusal fissures, or fissures with signs of early caries
Exclusion criteria
* children with major systemic disease or taking long-term medications * not cooperative or refuse dental treatments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| dental caries | 3 years | tooth decay appearing as a cavity on tooth surface |
Countries
China
Outcome results
None listed