Giomer vs Glass Ionomer Cement for ART Occlusoproximal Restorations: a Randomized Clinical Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02962713|
Recruitment Status : Active, not recruiting
First Posted : November 11, 2016
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Procedure: ART with Equia Procedure: ART with Giomer Beautifil-Bulk Restorative||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||181 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Giomer vs Glass Ionomer Cement for ART Occlusoproximal Restorations: a Randomized Clinical Trial|
|Actual Study Start Date :||November 6, 2017|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||October 2020|
Active Comparator: ART with Equia
Occlusal-proximal restoration in primary molars using Equia (Easy/Quick/Unique/Intelligent/Aesthetic) from GC Corp, encapsulated, pre-dosed and mechanized handling.
Procedure: ART with Equia
Occlusal-proximal ART restorations in primary molars using Equia (Easy/Quick/Unique/ Intelligent/Aesthetic) 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.
Experimental: ART with Giomer Beautifil-Bulk Restorative
Occlusal-proximal restoration in primary molars using Giomer Beautifil-Bulk Restorative (SHOFU Inc)
Procedure: ART with Giomer Beautifil-Bulk Restorative
Occlusal-proximal ART restorations in primary molars using Giomer will be performed. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with Giomer Beautifil-Bulk Restorative and occlusion will be checked.
- Longevity of atraumatic restoration using Roeleveld et al. (2006) criteria [ Time Frame: up to 24 months ]The treatments will be classified as successful when they present a clinical satisfactory aspect. Otherwise, "minor failure" will be analyzed. "Minor failures" are those in which there is a defect in the restoration, but it does not interfere in the tooth health.
- Cost-efficacy assessment based on Takanashi et al., 2004; Oscarson et al., 2003;Floriano et al., 2013 [ Time Frame: an average of 24 months ]The direct cost analysis of the ART performed with the encapsulated GICs will be based on previous publications (Takanashi et al., 2004; Oscarson et al., 2003) adjusted to the Brazilian reality (Floriano et al., 2013). For this, we will consider professional cost and cost of the procedure itself.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962713
|University of Sao Paulo|
|Sao Paulo, Brazil, 05508-000|
|Principal Investigator:||Daniela P Raggio, Professor||University of Sao Paulo|