Clinical Study of Filtek™ Bulk Fill Posterior Restorative in Class I and II Restorations

Launched by 3M · Dec 3, 2018

Keywords

ClinConnect Summary

This was a randomized, two- arm, non-inferiority study to evaluate the safety and clinical performance of resin composite, Filtek™ Bulk Fill.

Test apparatus: Apparatus for Test: Filtek™ Bulk Fill Posterior Restorative Apparatus for Control: 3M™ ESPE™ Filtek™ Z350XT, was approved by CFDA in 2010 and had been in the market for 5 years with some validated clinical data.

Sample Size of Subjects: Two-hundred forty (240) patients were expected to be recruited into the study and were randomly assigned to the test group and the control group according to the ratio of 1: 1; thus the number of case...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female,18 to 70 years old (including 18 and 70 years)
• • 2. Good health, no significant systemic disease;
• • 3. Normal opening degree;
• • 4. Molar (preferred) or premolar teeth
• • 5. 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;
• • 6. Cavity size: the buccolingual diameter of cavity is no less than the 1/3 and of the buccolingual cusp distance;
• • 7. Occlusion with natural teeth;
• • 8. Cavity depth: no less than 1/2 of dentin with a normal pulp status;
• • 9. Be able to understand informed consent and to provide written inform consent ;
• • 10. Be in good compliance with the protocol and willing to return to the site for follow up visits .
• Exclusion Criteria:
• • 1. Allergy to multiple medicines; allergy to resin or other polymer material;
• • 2. Acute caries, severe periodontitis, salivary glands malfunction, dysfunction/disorder of TMJ (temporomandibular joint);
• • 3. Poor oral hygiene, DMTF:18-34y \>4, 35-70y \>5;
• • 4. Teeth with abnormal staining ;
• • 5. Pathological abrasion (e.g. bruxism, clenching), acid corrosion, cracked-teeth and other non-caries diseases.
• • 6. Abnormal occlusion;
• • 7. Severe systemic or mental disorders;
• • 8. Pregnant or intended to be pregnant (pregnant test is positive ) or breast feeding women;
• • 9. Cavity do not meet the criteria based on the investigator's judgement;
• • 10. Resin Composite is not an appropriate restoration for the subject
• • 11. Pulp exposure or bottom of cavity is nearly close to the pulp;
• • 12. Subjects who is not able to return for the one year follow-up visit because of going abroad or other reasons;
• • 13. Subject is enrolled in other studies on investigational drug or device
• • 14. Cannot tolerate rubber dam isolation. -

Trial Officials