NCT02562456

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

Status unknown NA Last updated 11 December 2018

What this trial tests

NA trial testing ART using Fuji IX in Dental Caries in 428 participants. Status unknown.

Timeline

1 November 2015

Primary endpoint
10 June 2018

10 December 2019

Quick facts

Lead sponsor	University of Sao Paulo
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	428
Start date	1 November 2015
Primary completion	10 June 2018
Estimated completion	10 December 2019
Sites	1 location across Brazil

Drugs / interventions tested

• ART using Fuji IX
• Conventional Treatment — full drug profile →

Conditions studied

• Dental Caries — all drugs for Dental Caries →

Sponsor

University of Sao Paulo

Who can join

Adults 3 to 6, any sex, with Dental Caries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Atraumatic restorative treatment versus conventional restorative treatment for managing dental caries.
   Dorri M, Martinez-Zapata MJ, Walsh T, Marinho VC, et al · · 2017 · cited 55× · PMID 29284075 · DOI 10.1002/14651858.cd008072.pub2
2. Efficacy of conventional treatment with composite resin and atraumatic restorative treatment in posterior primary teeth: study protocol for a randomised controlled trial.
   Ladewig NM, Sahiara CS, Yoshioka L, Olegário IC, et al · · 2017 · cited 5× · PMID 28698331 · DOI 10.1136/bmjopen-2016-015542