Clinical trial NCT02568917: Effectiveness of ART and Conventional Treatment - Practice-based Clinical Trial
Official title: Effectiveness of Atraumatic Restorative Treatment and Conventional Restorations in Primary and Permanent Dentition: A Practice-based Clinical Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Dental Caries
Keywords: Dental Atraumatic Restorative Treatment
Composite Resins
Primary Teeth
Permanent Teeth
Clinical Effectiveness
Cost Analysis
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 800
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Dental caries is still a public health problem among Brazilian children and doubts still exist regarding the most effective restorative technique. The aim of this pragmatic randomized clinical trial is to evaluate the effectiveness of single and multiple-surfaces restorations performed following the Atraumatic Restorative Treatment (ART) premises compared with Conventional Treatment (CT) in primary and permanent teeth.

Methods: A total of 1,214 5-to-13 years-old children with at least one single or multiple-surface dentin caries lesion in primary or permanent molars will be selected in the public schools of Barueri-SP. The participants will be randomly divided into 2 groups: CT (Filtek Bulk Fill - 3M) and ART (Ketac Molar Easy Mix - 3M) and treated by ten untrained dentists in a dental office inside the schools. The restorations will be evaluated after 6, 12 and 24 months by an independent trained and calibrated examiner. The restoration and tooth survival, the cost-effectiveness analysis between the two groups and the operator preference of the treatment regarding the techniques will be also evaluated. Kaplan-Meier survival analysis and log-rank test will be applied to the survival of restorations. All the average event rates in the two groups will be modelled and compared with a Cox proportional hazard shared frailty model since there is an operator cluster-effect. The significance level for all analyses will be 5%.

Detailed description: Background: Dental caries is still a public health problem among Brazilian children and doubts still exist regarding the most effective restorative technique. The aim of this pragmatic randomized clinical trial is to evaluate the effectiveness of single and multiple-surfaces restorations performed following the Atraumatic Restorative Treatment (ART) premises compared with Conventional Treatment (CT) in primary and permanent teeth.

Methods: A total of 1,214 5-to-13 years-old children with at least one single or multiple-surface dentin caries lesion in primary or permanent molars will be selected in the public schools of Barueri-SP. The participants will be randomly divided into 2 groups: CT (Filtek Bulk Fill - 3M) and ART (Ketac Molar Easy Mix - 3M) and treated by ten untrained dentists in a dental office inside the schools. The restorations will be evaluated after 6, 12 and 24 months by an independent trained and calibrated examiner. The restoration and tooth survival, the cost-effectiveness analysis between the two groups and the operator preference of the treatment regarding the techniques will be also evaluated. Kaplan-Meier survival analysis and log-rank test will be applied to the survival of restorations. All the average event rates in the two groups will be modelled and compared with a Cox proportional hazard shared frailty model since there is an operator cluster-effect. The significance level for all analyses will be 5%.

Discussion: Our hypothesis is that despite similar expected effectiveness between ART using high viscosity GIC and conventional treatment using composite resin when treating single or multiple-surface in posterior primary and permanent teeth, ART presents superior cost-effectiveness. The results of this trial will support decision-making by clinicians and policy makers

Keywords: atraumatic restorative treatment, composite resin, glass ionomer cement, randomized clinical trial, cost effectiveness analysis

Eligibility criteria: Inclusion Criteria:

* Children aging between 6 and 14 years
* presenting good health conditions
* spontaneous demand for treatment by parents or legal guardians
* whose parents or legal guardians accept and sign the consent form
* with at least one occlusal or occlusal proximal caries lesion in primary or permanent 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 18 months
Secondary outcomes:
measure: Longevity of the tooth
timeFrame: Every 6 months up to 18 months
measure: Cost-effectiveness assessment
timeFrame: Through study completion, an average of 18 months
Other outcomes:
measure: Preference of the treatments by dentists
timeFrame: Baseline and after 6 months
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Daniela P Raggio, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Isabel C Olegário, PhD Student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olegario IC, Hesse D, Bonecker M, Imparato JC, Braga MM, Mendes FM, Raggio DP. Effectiveness of conventional treatment using bulk-fill composite resin versus Atraumatic Restorative Treatments in primary and permanent dentition: a pragmatic randomized clinical trial. BMC Oral Health. 2016 Aug 2;17(1):34. doi: 10.1186/s12903-016-0260-6.