Status:
COMPLETED
Clinical Study of Filtek™ Bulk Fill Posterior Restorative in Class I and II Restorations
Lead Sponsor:
3M
Conditions:
Dental Caries Class I
Dental Caries Class II
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Purpose of the Study:This study was to evaluate the 1 week, 1 year safety and effectiveness of dental composite resin (Filtek™ Bulk Fill Posterior Restorative) in restoring Class I and II dental cavit...
Detailed Description
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 Pos...
Eligibility Criteria
Inclusion
- 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;
- Be able to understand informed consent and to provide written inform consent ;
- Be in good compliance with the protocol and willing to return to the site for follow up visits .
Exclusion
- Allergy to multiple medicines; allergy to resin or other polymer material;
- Acute caries, severe periodontitis, salivary glands malfunction, dysfunction/disorder of TMJ (temporomandibular joint);
- Poor oral hygiene, DMTF:18-34y \>4, 35-70y \>5;
- Teeth with abnormal staining ;
- Pathological abrasion (e.g. bruxism, clenching), acid corrosion, cracked-teeth and other non-caries diseases.
- Abnormal occlusion;
- Severe systemic or mental disorders;
- Pregnant or intended to be pregnant (pregnant test is positive ) or breast feeding women;
- Cavity do not meet the criteria based on the investigator's judgement;
- Resin Composite is not an appropriate restoration for the subject
- Pulp exposure or bottom of cavity is nearly close to the pulp;
- Subjects who is not able to return for the one year follow-up visit because of going abroad or other reasons;
- Subject is enrolled in other studies on investigational drug or device
- Cannot tolerate rubber dam isolation. -
Key Trial Info
Start Date :
October 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2019
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03764059
Start Date
October 17 2017
End Date
November 14 2019
Last Update
July 21 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Stomatology Hospital of Capital Medical University
Beijing, Beijing Municipality, China, 010
2
Peking University Hospital of Stomatology
Beijing, Beijing Municipality, China, 010
3
Hospital of Stomatology Wuhan University
Wuhan, Hubei, China, 027