Cost-efficacy Between ART and Composite Resin Restorations in Primary Molars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02562456
Recruitment Status : Recruiting
First Posted : September 29, 2015
Last Update Posted : October 30, 2017
Information provided by (Responsible Party):
Daniela Prócida Raggio, University of Sao Paulo

Brief Summary:
The aim of this randomized clinical trial study is to compare the longevity of ART using high viscosity GIC and conventional treatment using composite resin in posterior primary teeth. As secondary outcomes, cost-efficacy and patient's self-reported discomfort will also be tested. Children aging between 3 to 6 years old presenting at least one occlusal and/or occlusal-proximal cavity will be randomly assigned in two groups according to the dental treatment - ART with high viscosity GIC (experimental group) or composite resin restoration (control group) -, which will be performed at dental care trailer located in a Educational Complex in Barueri/SP, Brazil. The unit of analysis for randomization will be the child. A number of 240 teeth presenting occlusal cavities and 188 teeth presenting occlusal-proximal cavities were set after sample size calculation. The groups will still be stratified according to children's caries experience. The primary outcome will be the restorations' longevity, which will be assessed after 6, 12, 18 and 24 months by two examiners through clinical examination of treatment according to Frencken and Holmgren (2001) criteria for occlusal cavities and Roeleveld et al. (2006) criteria for occlusal-proximal ones. 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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02562456

Contact: Daniela P Raggio, PhD

Complexo Educacional Carlos Osmarinho de Lima - Trailer USP Recruiting
Barueri, São Paulo, Brazil
Contact: Mariana M Braga, PhD   
Sub-Investigator: Nathalia M Ladewig, PhD stud         
Sub-Investigator: Isabela Floriano, PhD stud         
Sponsors and Collaborators
University of Sao Paulo
Study Chair: Daniela P Raggio, PhD University of Sao Paulo

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Daniela Prócida Raggio, Associate Professor of Pediatric Dentistry Department, University of Sao Paulo Identifier: NCT02562456     History of Changes
Other Study ID Numbers: RECART
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017

Keywords provided by Daniela Prócida Raggio, University of Sao Paulo:
Dental Atraumatic Restorative Treatment
Composite Resins
Primary Teeth
Clinical Efficacy
Cost Analysis

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Salicylic Acid
Z 350
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs