Effectiveness of ART and Conventional Treatment - Practice-based Clinical Trial
NCT ID: NCT02568917
Last Updated: 2020-06-12
Study Results
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Basic Information
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SUSPENDED
NA
800 participants
INTERVENTIONAL
2020-08-31
2022-08-31
Brief Summary
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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%.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Conventional Restoration
Conventional Restoration - Composite Resin (Bulk Fill)
Conventional Restoration - Composite Resin (Bulk Fill)
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.
Atraumatic Restorative Treatment
Atraumatic Restorative Treatment - Ketac Molar Easy Mix
Atraumatic Restorative Treatment - Ketac Molar Easy Mix
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.
Interventions
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Atraumatic Restorative Treatment - Ketac Molar Easy Mix
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.
Conventional Restoration - Composite Resin (Bulk Fill)
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
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Inclusion Criteria
* 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
* presence of fistula or abscess near the selected tooth
* presence of pulp exposure in the selected tooth
* presence of mobility in the selected tooth
6 Years
14 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Daniela Prócida Raggio
Associated Professor
Principal Investigators
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Daniela P Raggio, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Isabel C Olegário, PhD Student
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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University of São Paulo
São Paulo, , Brazil
Countries
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References
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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.
Other Identifiers
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EFFART
Identifier Type: -
Identifier Source: org_study_id
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