Cost-efficacy Between ART and Composite Resin Restorations in Primary Molars
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|ClinicalTrials.gov Identifier: NCT02562456|
Recruitment Status : Recruiting
First Posted : September 29, 2015
Last Update Posted : October 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Procedure: ART with Fuji IX Procedure: Restoration with Filtek Z-350 composite resin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||428 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Difference of Cost-efficacy Between Atraumatic Restoration Treatment (ART) and Composite Resin Restorations in Primary Molars: A Randomized Clinical Trial|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||October 2019|
Active Comparator: Conventional restorations using Filtek Z-350 composite resin
Occlusal and occlusal-proximal composite resin restorations in primary molars using the Scotchbond Multi-purpose adhesive system and the Filtek Z-350 composite resin.
Procedure: Restoration with Filtek Z-350 composite resin
Occlusal and occlusal-proximal composite resin restorations in primary molars using the Scotchbond Multi-purpose adhesive system and the Filtek Z-350 composite resin wil be performed. Local anesthesia will be used. Absolute isolation will be performed using rubber dam and clamp. Access to caries lesion will be done using a round bur. Infected carious tissue will be removed with hand instruments. The cavity will be etched using 37% phosphoric acid for 15 seconds followed by rising and drying for the same amount of time. The cavity will be restored with composite resin. Occlusion will be checked.
Experimental: Atraumatic Restorative Treatment using Fuji IX
Occlusal and occlusal-proximal ART restorations in primary molars using the high viscosity GIC Fuji IX.
Procedure: ART with Fuji IX
Occlusal and occlusal-proximal ART restorations in primary molars using the high viscosity GIC Fuji IX will be performed. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with GIC (Glass Ionomer Cement). The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed and occlusion will be checked.
- The restoration survival [ Time Frame: Every 6 months up to 24 months. ]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.
- Child self-reported discomfort [ Time Frame: Immediately after treatment (in the same appointment) ]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.
- Cost-efficacy assessment [ Time Frame: Through study completion, an average of 24 months ]Treatment costs will be calculated considering professional costs and procedure costs. In order to calculate the professional cost the time spent in each session will be converted in hours and multiplied by the medium income of the dentist per hour as related by the Brazilian Ministry of Labour and Employment ($36,23). On the other hand, to estimate the procedure cost, it will be considered both variable cost, which includes electricity and equipment depreciation, and materials cost. To calculate the equipment depreciation (peripherals, dental chair and instrumental), we will consider their price, the lifespan of five years and a monthly use of 160 hours, using an estimate value per hour of $1,81. 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 and obtained by the medium of the values from different places that commercialized the referred products.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562456
|Contact: Daniela P Raggio, PhDemail@example.com|
|Complexo Educacional Carlos Osmarinho de Lima - Trailer USP||Recruiting|
|Barueri, São Paulo, Brazil|
|Contact: Mariana M Braga, PhD firstname.lastname@example.org|
|Sub-Investigator: Nathalia M Ladewig, PhD stud|
|Sub-Investigator: Isabela Floriano, PhD stud|
|Study Chair:||Daniela P Raggio, PhD||University of Sao Paulo|