Clinical Performance of Two Different Restorative Materials in Restoring Class II Cavities of Pri… (NCT06000085) | Clinical Trial Compass
UnknownNot Applicable
Clinical Performance of Two Different Restorative Materials in Restoring Class II Cavities of Primary Molars
Egypt124 participantsStarted 2022-12-30
Plain-language summary
The aim of the present study is to assess Flowable Giomer Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia Forte (GC Corporation, Tokyo,
Japan) in class II cavities of primary molars regarding the following objectives:
The primary objective To evaluate and compare the clinical performance of Flowable Giomer Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia Forte (GC Corporation, Tokyo, Japan) in restoring class II cavities of primary molars after 3,6, and 12 months. The secondary objective To assess the effect of different independent variables on the treatment outcome of the experimental restorative materials.
Research question:
Is there a difference in the clinical performance between flowable giomers and highly viscous glass ionomer in restoring class II cavities of primary molars?
Null Hypothesis There is no difference in the clinical performance between Flowable Giomer Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia Forte (GC Corporation, Tokyo, Japan) after one year of follow up.
Who can participate
Age range4 Years – 8 Years
SexALL
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Inclusion criteria
✓. 4 to 8 years old medically free children.
✓. Cooperative children classified as class 3 or 4 based on Frankel et al. classification
✓. Children who had at least one active dentinal carious lesion on proximal surface of primary molars
✓. Primary molars with active dentinal carious lesion on their proximal surface score 4, 5 using ICDAS.
✓. Primary molars with proximal carious lesion extended to outer and middle third of dentin scored D1and D2 that will be detected by bitewing radiograph.
✓. Simple or compound class II cavities be present
✓. The antagonist and the adjacent tooth should be present
✓. Primary molar should have at least 2/3 of the root present
Exclusion criteria
✕. Refusal of the parents to sign the informed consent
✕
What they're measuring
1
The clinical performance of Flowable Giomer Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia Forte (GC Corporation, Tokyo, Japan) in restoring class II cavities of primary molars