A study to compare the decay arrest of two different fluoride products when applied to the teeth of children aged between 2 and 5 years in a rural setting near Port Moresby, Papua New Guinea.
Effectiveness of bi-annual application of 38% silver diamine fluoride solution compared to 5% sodium fluoride varnish on arrested carious lesions on primary teeth in children aged 2-5 years in a rural setting near Port Moresby, Papua New Guinea
University of Otago
104 participants
Dec 4, 2018
Interventional
Conditions
Summary
The hypothesis is that bi-annual topical application of 38% silver diamine fluoride will be superior to bi-annual topical application of 5% sodium fluoride varnish in arresting dental decay in children 2-5 years of age. This is an interventional parallel arm, randomised study. The participants will be recruited from a rural Papua New Guinean village. Consent will be obtain from the children and their guardian. The children will be clinically examined, visual and tactile, at baseline, 6 and 12 months by a callibrated dental practitioner. Dental caries progression will be assessed and recorded. The primary outcome measure of the study is the number of active caries arrested at the end of the trial.
Eligibility
Inclusion Criteria4
- Children aged 2 to 5 years old from a rural village in Papua New Guinea
- In good health
- Have at least one carious tooth.
- Have obtained informed consent and able to accept intervention
Exclusion Criteria5
- Children younger than two years or older than five years
- Children who exhibit signs of tooth non-vitality such as pulp exposure, presence of
- an abscess or sinus, hypermobility, retained roots of teeth
- Children who are undergoing dental treatment or long-term medical treatment
- Children with special healthcare needs,
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Interventions
One local dental practitioner who is also in the research team will apply the medicaments to the teeth with signs of dental decay. The two treatment arms include: Group 1: Bi-annual topical application of a thin film of 38% silver diamine fluoride solution and Group 2: Bi-annual topical application of a thin film of 5% sodium fluoride varnish Clinical examinations will be conducted at baseline, 6 and 12 months period. 38% SDF solution or 5% NaF varnish will be applied at baseline and re-applied during the second follow up visit in 6 months. Final data collection will be done at 12 months
Locations(1)
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ACTRN12620000452998