None listed
Conditions
Brief summary
The primary aim is to determine, over a 12 month period, the relative dental caries (tooth decay) arrest and prevention abilities on the primary teeth of children aged one to eight years of a once-only treatment of 38% silver diamine fluoride, compared to three-monthly applications of 5% sodium fluoride varnish in the Tasmanian clinical situation. The secondary aims are to compare: 1/ The dental caries prevention and arrest abilities of once-only treatments of silver diamine fluoride, silver diamine fluoride/potassium iodide, and silver diamine fluoride/potassium iodide/glass ionomer fissure sealant . 2/ The effectiveness as measured by relative cost, patient and clinician acceptability of treating tooth decay on the primary teeth of children of silver diamine fluoride, silver diamine fluoride/potassium iodide, silver diamine fluoride/potassium iodide/glass ionomer fissure sealant, and the standard dental treatment of restorations and extractions as determined by calibrated dentists if it were feasible to do the care under local anaesthetic.
Interventions
All treatments will be undertaken by an oral health therapist and applied using a micro brush at the time of entering the study.
There will be three treatment groups (and one control group):
1/ A once-only treatment of 38% silver diamine fluoride,
2/ A once-only treatment of 38% silver diamine fluoride followed by an application of potassium iodide.
3/ A once-only treatment of 38% silver diamine fluoride followed by an application of potassium iodide then covered by a glass ionomer fissure seal
All treatments will be undertaken by an oral health therapist and applied using a micro brush at the time of entering the study. There will be three treatment groups (and one control group): 1/ A once-only treatment of 38% silver diamine fluoride, 2/ A once-only treatment of 38% silver diamine fluoride followed by an application of potassium iodide. 3/ A once-only treatment of 38% silver diamine fluoride followed by an application of potassium iodide then covered by a glass ionomer fissure sealant, The sealant is expected to remain permanently in place, but its role is to help the soak deeper into the carious tooth and so it is not of concern if the sealant falls off after a short time period. All children will also receive three-monthly oral health promotion in twice daily tooth brushing with a fluoride-containing toothpaste.
Sponsors
University of Tasmania
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
1 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria are children aged one to eight years with multiple carious primary teeth and who are being entered on the Oral Health Services Tasmania/Royal Hobart Hospital General Anaesthetic Waiting List.
Exclusion criteria
Developmental dental abnormalities such as enamel defects, serious chronic medical conditions, such as congenital heart disease and children with teeth with symptoms or signs that are pulpal in origin
Outcome results
None listed