An interventional study of Filtek™ Bulk Fill Posterior Restorative and Filtek™ Z350XT Universal Restorative in Dental Caries Class I and Dental Caries Class II, sponsored by 3M. Completed at 3 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-07-21.
Sponsored by 3M · Not applicable, Interventional, and Treatment
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 cavities in posterior teeth.
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 cases in each group was 120. Finally, a total of 240 subjects were randomly enrolled in the study, including 120 subjects in the test group and 120 subjects in the control group, which met the required sample size.
The study consisted of screening period (initial screening visit, post-preparation screening visit), 1-week follow-up visit and 1-year follow-up visit, during which all the tests required in the protocol would be conducted to select the subjects meeting the criteria for inclusion. The examination and evaluation of the initial screening period were supposed to be completed within 0.5 days. Then investigators would make an appointment with the subjects eligible for the initial screening for cavity preparation and tooth filling, the required time of which depended on the complexity of the tooth problem and would be completed within 0.5 days. Immediate evaluation of relevant indicators were offered to the subjects who were selected and qualified after preparation and patients with qualified score would continue to have the 1-week and 1-year follow-up visits.
Subjects were randomly assigned to either the test group (Filtek™ Bulk Fill Posterior Repository) or the control group (Filtek™ Z350XT) in a central random manner, using the corresponding test product or control product to fill and restore posterior teeth defects (class I or class II cavities).
Since all investigators were required to operate according to instructions, it was clear to them which product a subject was given. However, subjects and clinical evaluators were blinded regarding whether the test product (Filtek™ Bulk Fill Posterior Repository) or the control product (Filtek™ Z350XT) was used by the subjects.
Immediately after restoration placement, at 1 week and 1 year postoperative, two or three clinical evaluators from each site performed the clinical assessment (the third more senior evaluator performed the assessment and determination if the first two evaluators were not in agreement) per China Technical Instruction and Guidance of Resin Composite Restoration Material For CFDA Registration (Technical Instruction and Guidance in short). The clinical acceptable rate of the restoration at 1 year was the primary endpoint in this study.
AE/SAE were collected to evaluate the safety of Filtek™ Bulk Fill. Based on the assessment result, if the clinical acceptance rate of the two groups achieved the clinical acceptable rate defined in the protocol, it indicated that Filtek™ Bulk Fill was efficacious for class 1 and II restorations.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 240 is above the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →3M is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Exclusion Criteria:
The investigational device, Filtek™ Bulk Fill Posterior Restorative, was used for class 1 or 2 restorative in experimental group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality. Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments.
Device: Filtek™ Bulk Fill Posterior Restorative
The control device, Filtek™ Z350XT Universal Restorative, which was approved by CFDA in 2010 and has been in the market for 5 years with some validated clinical data, was used for class 1 or 2 restorative in control group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality. Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments.
Device: Filtek™ Z350XT Universal Restorative
The subjects were assigned to either the investigational device (Filtek™ Bulk Fill Posterior Restorative) or the control device (Filtek™ Z350XT Universal Restorative) per web-based randomization system.
The subjects were assigned to either the investigational device (Filtek™ Bulk Fill Posterior Restorative) or the control device (Filtek™ Z350XT Universal Restorative) per web-based randomization system.
Also known as: Filtek™ Supreme Ultra Universal Restorative, Filtek™ Supreme XTE Universal Restorative, Filtek™ Ultimate Universal Restorative
Clinical Acceptance Rate of Restoration at 1 Year After Replacement
According to Clinical Trial Guideline for Polymer-based Dental Restorative Materials (YY/T 0990-2015), the clinically acceptable definition of restoration at 1 year after replacement was as follows: The retention and fracture score of restoration at 1 year after replacement was A; the marginal fracture, the appearance and the marginal adaptationof restoration was A or B.
Time frame: 1 Year after restoration
| Milestone | Investigational Device/Experimental Group: Filtek™ Bulk Fill Posterior Restorative | Control Device/Control Group: Filtek™ Z350XT Universal Restorative |
|---|---|---|
| Started | 120 | 120 |
| Completed | 120 | 120 |
| Not completed | 0 | 0 |
According to Clinical Trial Guideline for Polymer-based Dental Restorative Materials (YY/T 0990-2015), the clinically acceptable definition of restoration at 1 year after replacement was as follows: The retention and fracture score of restoration at 1 year after replacement was A; the marginal fracture, the appearance and the marginal adaptationof restoration was A or B.
| Participants | Investigational Device/Experimental Group: Filtek™ Bulk Fill Posterior Restorative | Control Device/Control Group: Filtek™ Z350XT Universal Restorative |
|---|---|---|
| Acceptable restoration | 120 | 119 |
| unacceptable restoration | 0 | 1 |
Collected over Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Investigational Device/Experimental Group: Filtek™ Bulk Fill Posterior Restorative | 0/120 (0%) | 0/120 (0%) | 45/120 (37.5%) |
| Control Device/Control Group: Filtek™ Z350XT Universal Restorative | 0/120 (0%) | 0/120 (0%) | 36/120 (30%) |
| Event | Investigational Device/Experimental Group: Filtek™ Bulk Fill Posterior Restorative | Control Device/Control Group: Filtek™ Z350XT Universal Restorative |
|---|---|---|
| Non-target cariesGastrointestinal disorders | 20/120 | 5/120 |
| Upper respiratory infectionRespiratory, thoracic and mediastinal disorders | 5/120 | 8/120 |
| Post-operative tooth sensitivityGastrointestinal disorders | 8/120 | 3/120 |
| Impacted wisdom teethGastrointestinal disorders | 6/120 | 7/120 |
| Wisdom tooth extractionGastrointestinal disorders | 3/120 | 0/120 |
| Pericoronitis of non-target teethGastrointestinal disorders | 3/120 | 1/120 |
| AcneSkin and subcutaneous tissue disorders | 0/120 | 2/120 |
| Irregular dentitionGastrointestinal disorders | 1/120 | 2/120 |
| Chronic periodontitisGastrointestinal disorders | 1/120 | 2/120 |
| Sensitivity of non-target teeth after operationGastrointestinal disorders | 0/120 | 2/120 |
| Age, Continuous(years) | Interventional | Observational | Total |
|---|---|---|---|
| Mean | 27.97 ± 6.65 | 28.12 ± 7.76 | 28.05 ± 10.22 |
| Sex: Female, Male(Participants) | Interventional | Observational | Total |
|---|---|---|---|
| Female | 84 | 81 | 165 |
| Male | 36 | 39 | 75 |
| Race and Ethnicity Not Collected(Participants) | Interventional | Observational | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Clinical diagnosis of caries(participants) | Interventional | Observational | Total |
|---|---|---|---|
| Number | 119 | 120 | 239 |
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