Clinical trial NCT02562456: Cost-efficacy Between ART and Composite Resin Restorations in Primary Molars
Official title: Difference of Cost-efficacy Between Atraumatic Restoration Treatment (ART) and Composite Resin Restorations in Primary Molars: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Keywords: Dental Atraumatic Restorative Treatment
Composite Resins
Primary Teeth
Clinical Efficacy
Cost Analysis
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 428
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Research setting

The study will be performed in a dental care trailer which simulated a regular dental office and it is located inside a public school of the city Barueri (São Paulo, Brazil).

Sample size calculation

For sample size calculation, data regarding longevity of CT in occlusal and occlusoproximal restorations after 2 years were extracted from the literature as 86% for occlusal and 60% for occlusoproximal restorations. A difference of 15% and 20% between the longevity of CT and ART was set as non-inferiority limit. Considering the level of significance as 5%, power as 80% and adding 40% due to the study design (cluster per child), a number of 204 occlusal restorations and 240 occlusoproximal restorations will be needed.

Randomization

The child will be the unit of randomization which means that all eligible teeth of a participant will be treated according the same restorative approach. Randomization list will be obtained using blocks of 4, 6 and 8 generated by software Sealed Envelope Ltd. Opaque, sealed and sequentially numbered envelopes will be used for randomizing all participants immediately before restorative treatments' beginning.

Allocation concealment

To assure allocation concealment, the participant will be randomized immediately before the treatment. When two or more cavities is available, preventing the finalization of the treatment in only one session, breach of allocation concealment will be signalized in the participants' record.

Blinding

Due to differences between the techniques, it will be not possible to blind operators, participants and evaluators.

Operators

All operators will be masters or PhD students from the Pediatric Dentistry Department, Faculty of Dentistry, University of São Paulo, previously trained. All procedures will be performed with the assistance of a dental student previously trained to manipulate all restorative materials.

Eligibility criteria: 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

Primary outcomes:
measure: The restoration survival
timeFrame: Every 6 months up to 24 months.
Secondary outcomes:
measure: Cost-efficacy assessment
timeFrame: Through study completion, an average of 24 months
measure: Child self-reported discomfort
timeFrame: Immediately after treatment
measure: Cooperation
timeFrame: Immediately after treatment
Other outcomes:
Locations:
city: Barueri
country: Brazil
facility: Complexo Educacional Carlos Osmarinho de Lima - Trailer USP
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Daniela P Raggio, PhD
role: STUDY_CHAIR
References:
citation: Ladewig NM, Sahiara CS, Yoshioka L, Olegario IC, Floriano I, Tedesco TK, Mendes FM, Braga MM, Raggio DP. Efficacy of conventional treatment with composite resin and atraumatic restorative treatment in posterior primary teeth: study protocol for a randomised controlled trial. BMJ Open. 2017 Jul 10;7(7):e015542. doi: 10.1136/bmjopen-2016-015542.