Status:
COMPLETED
Clinical Evaluation of a Bulk Fill Resin Composite
Lead Sponsor:
Ivoclar Vivadent AG
Conditions:
Dental Caries
Unsatisfactory or Defective Restoration of Tooth
Eligibility:
All Genders
19-90 years
Phase:
NA
Brief Summary
The purpose of this clinical trial is to measure the clinical outcomes of Tetric PowerFill Class I and II restorations cured in 3 seconds with the Bluephase PowerCure curing unit.
Eligibility Criteria
Inclusion
- Each subject must need at least 1 restoration in a vital posterior tooth
- Must have given written consent to participate in the trial
- Replacement of defective restorations (i.e. fractured, stained, unaesthetic) with or with-out caries are acceptable
- Must be available for the required follow-up visits over 3 years
- Restored teeth must have occlusal contact with opposing teeth or restored teeth
- Restoration width should be equal to or greater than 1/3 the distance from buccal to lin-gual cusp tips
- 75% of the restorations Class II (minimum) and 25% Class I
- Each Class II will have at least one proximal contact
- 75% in molars (minimum) and 25% in premolars
- All restored teeth must have at least one occlusal contact in habitual closure
- Must have 20 or more teeth
Exclusion
- If they have an allergy to ingredients of the materials under investigation (monomers)
- Do not meet all inclusion criteria above
- Have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or are immunocompromised) or disabilities meaning they may not be able to tolerate the time required to complete the restorations or to provide adequate oral hygiene
- Have xerostomia either by taking medications known to produce xerostomia or those with radiation-induced xerostomia or Sjogren's syndrome - as dry mouth increases tooth and restoration wear as well as the development of caries.
- Have teeth with advanced or severe periodontitis, rampant caries or poor oral hygiene which may require extraction of the teeth to be restored
- Present with any systemic or local disorders that contraindicate the dental procedures included in this study
- Have unstable occlusion
- Have severe grinding/bruxing or clenching or need TMJ-related therapy
- Have tooth with exposed pulp during preparation or caries removal
- Teeth that are non-vital or that exhibit signs of pulpal pathology for restoration
- Teeth that require cuspal build-ups involving more than one cusp
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04686422
Start Date
December 1 2017
End Date
June 30 2021
Last Update
October 23 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UAB School of Dentistry
Birmingham, Alabama, United States, 35294-0007