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Effectiveness of ART and Conventional Treatment - Practice-based Clinical Trial
Effectiveness of Atraumatic Restorative Treatment and Conventional Restorations in Primary and Permanent Dentition: A Practice-based Clinical Trial
1 other identifier
interventional
800
1 country
1
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%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2015
CompletedFirst Posted
Study publicly available on registry
October 6, 2015
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedJune 12, 2020
June 1, 2020
1 year
September 29, 2015
June 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The restoration survival
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.
Every 6 months up to 18 months
Secondary Outcomes (2)
Longevity of the tooth
Every 6 months up to 18 months
Cost-effectiveness assessment
Through study completion, an average of 18 months
Other Outcomes (1)
Preference of the treatments by dentists
Baseline and after 6 months
Study Arms (2)
Conventional Restoration
ACTIVE COMPARATORConventional Restoration - Composite Resin (Bulk Fill)
Atraumatic Restorative Treatment
EXPERIMENTALAtraumatic Restorative Treatment - Ketac Molar Easy Mix
Interventions
Occlusal and occlusal-proximal ART restorations in primary and permanent molars using the high viscosity GIC Ketac Molar Easy mix 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.
Occlusal and occlusal-proximal composite resin restorations in primary and permanent molars using the Scotchbond Multi-purpose adhesive system and the Filtek Bulk Fill composite resin wil be performed. Local anesthesia can be used if necessary. 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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of São Paulo
São Paulo, 05508-000, Brazil
Related Publications (1)
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.
PMID: 27485432DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniela P Raggio, Professor
University of Sao Paulo
- PRINCIPAL INVESTIGATOR
Isabel C Olegário, PhD Student
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Professor
Study Record Dates
First Submitted
September 29, 2015
First Posted
October 6, 2015
Study Start
August 1, 2020
Primary Completion
August 1, 2021
Study Completion
August 1, 2022
Last Updated
June 12, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share