University of Alabama at Birmingham School of Dentistry, 605 School of Dentistry Building, 1919 7th Avenue South
Birmingham, Alabama, 35233-2005, United States
NCT Number: NCT01369108
Study hypothesis: a new, low polymerization stress flowable composite performs no differently to a conventional, highly filled composite filling material when used as a restorative in small cavities in back teeth.
Study will evaluate the clinical performance of a low shrinking flowable composite filling material, compared with a conventional, highly filled composite restorative when used to permanently fill small cavities in molar and premolar teeth in adult patients.
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Notify Me19 year and older
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35233-2005, United States
The study will evaluate clinical performance of a low shrink flowable composite filling material and compare it with a conventional, highly filled composite. The study materials will be used to restore small cavities in molar and premolar teeth in adult patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Restoration of small Class V and I cavities in molar and premolar teeth
Other names: Filtek Supreme Ultra Flowable Restorative 3M ESPE)
Restoration of small Class V and I cavities in molar and premolar teeth
Time frame: baseline, 6, 12 and 24 months
Clinical performance reported on 6 parameters as the % of teeth with perfect scores ("A" rating).
Cvar & Ryge scores measure 6 parameters: Anatomic form (rated A,B= satisfactory, C=unsatisfactory); Color Match (A=match, B=mismatch, but within normal, C=mismatch outside normal); Marginal Adaptation (A=no visible crevice, B=no exposure of dentin, C=defect to enamel-dentine junction, D= fracture, missing); Marginal Discoloration (A=none, B= marginal discoloration, C=marginal discoloration to pulpal direction); Surface Integrity (A=smooth, B=slight rough, C=Pitted, D=fracture)'Secondary caries (A=none, D=present).
Time frame: baseline, 6, 12 and 24 months
Sensitivity to cold was measured by applying a cotton pellet soaked with pulp vitality refrigerant spray (Endo Ice, Coltene/ Whaledent, Cuyahoga Falls, OH, USA) to the tooth for three seconds. Sensitivity to biting was measured by having the patient bite on a cotton roll for five seconds. After each test, the subject was asked to place an ''X'' on a 10-mm line labeled ''1'' on the left and ''10'' on the right. Patients were told that a ''10'' represents the worst pain they can imagine (ie, childbirth, major surgery, or kidney stone) and that ''1'' represents no sensation at all.
Solventum US LLC
Industry
Clinical Evaluation of a Low Shrinkage Flowable Resin Composite in Adult Teeth
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