The purpose of this study is to extend our knowledge concerning the clinical performance of two dental filling materials in molars. The study will compare two high-strength glass-ionomer filling materials. The investigators hypothesize that after two years (1) the clinical performance of both filling materials shows a similar survival rate, (2) the ChemFil Rock fillings show similar or higher incidence of fracture than Fuji IX GP fillings.
In this longitudinal prospective randomized control clinical trial, posterior restorations (Class II) will be placed and evaluated for their clinical performance. The study will compare two restorative systems currently on the market in USA: both high-strength glass-ionomer (GI) restorative materials. The study restorations will be monitored for a period of up to 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
93
High-viscous glassionomer restoration of Chemfil ROCK used as posterior dental filling material.
High-viscous glassionomer restoration of Fuji IX GP Extra used as posterior dental filling material.
Mott Childrens' Health Center
Flint, Michigan, United States
Survival Rate
* Cut-off: Restoration failure as determined by (need for) replacement due to fracture and retention losses within both arms. * "Clinically successful" is defined as: no need for replacement due to fracture or retention losses.
Time frame: 2 years
Caries Incidence Associated With Restoration
\- "Caries free restorations" is defined as: free of caries associated with restoration.
Time frame: 2 years
Restored Tooth Performance
* Cut-off: Restored tooth failure (tooth in need of repair or management) as determined by Tooth integrity (enamel/tooth fracture), Sensitivity and Vitality assessment within both arms. * "Clinically successful" is defined as: No need for repair or management due to sensitivity or loss of tooth integrity or vitality.
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.