Clinical Evaluation of a Bulk Fill Resin Composite

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of a Bulk Fill Resin Composite

Conditions
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Dental Caries, Unsatisfactory or Defective Restoration of Tooth

Intervention / Treatment
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* Device: Tetric PowerFill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tetric PowerFill Class I and II restorations<br> | Device: Tetric PowerFill<br>* Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative hypersensitivity | assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 No pain at all - 10 The worst pain imaginable) following the FDI criteria on a scale from 1 very good to 5 unacceptable | Baseline to 36 months | 
| Pulp integrity | Restored teeth are assessed by a cold air stimuli test (air syringe) by VAS (Visual Analog Scale, 0 No pain at all - 10 The worst pain imaginable) | Baseline to 36 months | 
| Overall survival rate | Kaplan-Meier survival analysis will be performed to estimate the lifetime of the material based on clinical failures | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FDI criteria (Surface lustre, surface staining, colour match, material fracture, occlusal wear, tooth integrity) | assessed following the FDI criteria on a scale from 1 very good to 5 unacceptable | Baseline to 36 months |