Dental Caries Clinical Trial
Official title:
Difference of Cost-efficacy Between Atraumatic Restoration Treatment (ART) and Composite Resin Restorations in Primary Molars: A Randomized Clinical Trial
Verified date | December 2018 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this randomized clinical trial study is to compare the longevity of Atraumatic Restorative Treatment (ART) using high viscosity GIC and Conventional Treatment using composite resin under rubber dam isolation and local anesthesia (CT) in primary molars. As secondary outcomes, cost-efficacy, self-reported discomfort and cooperation will also be tested. Children aging between 3 to 6 years old presenting at least one occlusal and/or occlusoproximal cavity will be randomly assigned to one of two groups according to the dental treatment: ART (experimental group) or CT (control group). The dental treatment will be performed at a dental care trailer located in a Public School in Barueri (São Paulo, Brazil). The unit of analysis for randomization will be the child. A number of 204 teeth presenting occlusal cavities and 240 teeth presenting occlusoproximal cavities were set after sample size calculation. The primary outcome will be the restorations' longevity, which will be assessed after 6, 12, 18 and 24 months by two evaluators through clinical examination according to Frencken et al. (1998) criteria for occlusal restorations and Roeleveld et al. (2006) criteria for occlusoproximal restorations. The time spent during the dental treatment and all materials used will be considered for estimating the cost-efficacy of each treatment. The individual's discomfort will be also measured after each dental procedure using the Facial Scale of Wong-Baker. Cooperation will be assessed by the operator using a 5-point scale.
Status | Active, not recruiting |
Enrollment | 428 |
Est. completion date | December 10, 2019 |
Est. primary completion date | June 10, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 6 Years |
Eligibility |
Inclusion Criteria: - Children aging between 3 and 6 years - presenting good health conditions - whose parents or legal guardians accept and sign the consent form - with at least one occlusal or occlusal proximal caries lesion in primary molars - only occlusal and/or occlusal-proximal surfaces with caries lesions with dentin involvement Exclusion Criteria: - severe behavioral issues - presence of fistula or abscess near the selected tooth - presence of pulp exposure in the selected tooth - presence of mobility in the selected tooth |
Country | Name | City | State |
---|---|---|---|
Brazil | Complexo Educacional Carlos Osmarinho de Lima - Trailer USP | Barueri | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The restoration survival | The treatments will be classified as successful when they present a clinical satisfactory aspect. Otherwise, "minor failures" will be analyzed. "Minor failures" are those in which there is a defect in the restoration/crown, but it does not interfere with the tooth health. | Every 6 months up to 24 months. | |
Secondary | Cost-efficacy assessment | Treatment costs = professional costs + procedure costs. Professional cost: the time spent in each session will be converted in hours and multiplied not only by the medium income of the dentist per hour added 40% of dangerousness but also by the medium income of a dental assistant added 20% of insalubrity Procedure cost: variable cost (equipment & instruments depreciation and electricity) and and materials cost. To calculate the equipments' and instruments' depreciation, we will consider their price, the lifespan of 5 and 3 years respectively and a monthly use of 160 hours. To calculate materials' costs, all materials used in each procedure will have their specifications and quantity registered. Prices will be inferences from the market value converted in US Dollars obtained by the medium of the values from different places that commercialized the referred products. If the restorative treatment requires repairs, the additional cost of it will also be considered. |
Through study completion, an average of 24 months | |
Secondary | Child self-reported discomfort | The acceptability of each type of treatment will be evaluated using the Facial scale of Wong-Baker (Wong; Baker, 1998). This scale indicates the discomfort of an individual who has to choose among six faces, each one expressing different facial countenance. The first image is a smiling happy face, indicating no discomfort, followed by gradually less cheerful expressions, up to the last one which is a very sad face covered by tears, indicating great discomfort. The participant will be asked to choose the face that is more similar to how he or she felt during the treatment. This answer should be given solely by the child, which means, no parental or professional interferences. The facial scale of Wong-Baker will be applied right after the end of each restorative treatment session. | Immediately after treatment | |
Secondary | Cooperation | Cooperation will be evaluated by the operator immediately after the end of the treatment using a 5-point scale: 1- Good behaviour, 2- Reasonable behaviour, 3- Indiferent, 4- Bad behaviour, 5- Really bad behaviour. | Immediately after treatment |
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