Clinical Study of Filtekâ„¢ Bulk Fill Posterior Restorative in Class I and II Restorations (NCT03764059) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study of Filtekâ„¢ Bulk Fill Posterior Restorative in Class I and II Restorations
China240 participantsStarted 2017-10-17
Plain-language summary
Purpose of the Study:This study was to evaluate the 1 week, 1 year safety and effectiveness of dental composite resin (Filtekâ„¢ Bulk Fill Posterior Restorative) in restoring Class I and II dental cavities in posterior teeth.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male or female,18 to 70 years old (including 18 and 70 years)
✓. Good health, no significant systemic disease;
✓. Normal opening degree;
✓. Molar (preferred) or premolar teeth
✓. Cavity type with belongs to any of the following： 1) Class I, including the failed class I restoration which require to be repaired.; 2) Class II, including premolar and molar except the second molar (the failed class II restoration which require to be repaired is also included), and the gingival wall of cavity is above the free gingival margin coronally; 3) Class II cavity on the second molar when the third molar exists, and the gingival wall of cavity is above the free gingival margin coronally; 4) Class II, MO or MOD cavity on the second molar when the third molar does not exist (the failed class II restoration which require to be repaired is also included), and the gingival wall of cavity is above the free gingival margin coronally;
✓. Cavity size: the buccolingual diameter of cavity is no less than the 1/3 and of the buccolingual cusp distance;
✓. Occlusion with natural teeth;
✓. Cavity depth: no less than 1/2 of dentin with a normal pulp status;
Exclusion criteria
✕. Allergy to multiple medicines; allergy to resin or other polymer material;
✕. Acute caries, severe periodontitis, salivary glands malfunction, dysfunction/disorder of TMJ (temporomandibular joint);
What they're measuring
1
Clinical Acceptance Rate of Restoration at 1 Year After Replacement