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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 July 2023
• Main ID: NCT03764059
• Date of registration: 03/12/2018
• Prospective Registration: No
• Primary sponsor: 3M
• Public title: Clinical Study of Filtek™ Bulk Fill Posterior Restorative in Class I and II Restorations
• Scientific title: A Randomized Multicenter Two-Arm Clinical Study to Evaluate the Safety and Efficacy of Filtek™ Bulk Fill Posterior Restorative in Class I and II Restorations
• Date of first enrolment: October 17, 2017
• Target sample size: 240
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03764059
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Xiaoyan Wang, Director
• Affiliation: Endodontics department of Peking University hospital of stomatology

Key inclusion & exclusion 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. -



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dental Caries Class I

Dental Caries Class II

Intervention(s)

Device: Filtek™ Z350XT Universal Restorative

Device: Filtek™ Bulk Fill Posterior Restorative

Primary Outcome(s)

Clinical Acceptance Rate of Restoration at 1 Year After Replacement [Time Frame: 1 Year after restoration]

Secondary ID(s)

MDI0102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/07/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03764059