Ignite Creation Date:
2024-05-06 @ 9:22 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02962713
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2016-08-30
Brief Title:
Giomer vs Glass Ionomer Cement for ART Occlusoproximal Restorations a Randomized Clinical Trial
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Giomer vs Glass Ionomer Cement for ART Occlusoproximal Restorations a Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although the Atraumatic Restorative Treatment ART is well settled in the literature regarding occlusal-proximal cavities the longevity of these restorations is still lower when compared to occlusal ones This factor is often associated with low mechanical properties of glass ionomer cements GIC The objective of this randomized clinical trial is to evaluate the long-term cost-effectiveness of two different materials an encapsulated GIC - Equia GC Corp compared with Giomer Beautifill Bulk Restorative - Shofu used as restoratives materials in occlusal-proximal ART restorations of primary molars Children aged between 4 and 8 years will be selected in schools in the city of Cerquilho São Paulo All restorations will be held following the precepts of the ART and the manufacturers instructions The restorations will be evaluated after 3 6 12 18 and 24 months according to Roeleveld et al 2006 criteria To verify the survival of the restorations will be used Kaplan-Meier survival analysis and log rank test To evaluate the association between the clinical variables Cox regression test will be applied For the cost analysis will be used analysis of variance The level of significance for all tests will be considered to 5
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None