Prospective, Split-mouth, Comparative Study to Compare Clinical Outcomes of Two Different Posterior Composite

Study Overview
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Brief Summary
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The objective of this 2-year split mouth comparative study, a randomized controlled study, is to determine whether the simplified placement procedure of the ultra-rapid polymerizing Tetric PowerFlow/ Tetric PowerFill with a reduced light polymerization time (3 s), yields the same clin-ical results as widely used commercially available dental composites (Tetric EvoCeram Bulk Fill, Tetric EvoFlow Bulk Fill) requiring up to 40 seconds of light polymerization time.

Detailed Description
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Patients, requiring posterior tooth restorations Class I and II or requesting amalgam restoration replacement, were treated in the clinical investigation. Each patient received two composite restorations in the posterior region.

Official Title
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A 24-Month Clinical Evaluation of an Ultra-rapid Polymerizing Resin Composite

Conditions
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Defective Tooth Restorations, Caries

Intervention / Treatment
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* Device: Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow)
* Device: Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Each subject must need at least 2 restorations in a vital posterior tooth (in different quadrants) Restorations may be indicated for caries removal and restoration, replacement of defec-tive restorations (i.e. fractured, stained, unaesthetic), or requested replacement of un-aesthetic restorations. Must have given written consent to participate in the trial Must be available for the required follow-up visits over 2 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 One, two or three surfaces per restoration 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 with evidence of bilateral posterior tooth contacts Teeth that require one or no cuspal build-ups Vital tooth Preoperative sensibility on the teeth to be treated at maximum 3 on visual analog scale (10 = maximum) Patient wishes to be treated in this clinical trial after oral information by the operator and after signing the informed patient form Exclusion Criteria: Allergies to ingredients of the materials under investigation (monomers) Do not meet all inclusion criteria above Have medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or are immunocompromised) or disabilities rendering them unable to tolerate the time required to complete the restorations or to provide adequate oral hygiene Suffer from xerostomia either by taking medications known to produce xerostomia or those with radiation induced xerostomia or Sjogren's syndrome subjects 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 Patients reporting having severe grinding/bruxing or clenching or in need of TMJ-related therapy Have tooth with exposed pulp during preparation or caries removal or require indirect pulp capping Inclusion of teeth that are non-vital or that exhibit signs of pulpal pathology (pulpitis) If the working field cannot be maintained in a dry state for treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Split-mouth Design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fast-curing composites<br> | Device: Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow)<br>* Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.<br>|
| Other: Conventionally applied composites<br> | Device: Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill)<br>* Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative tooth sensitivity | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| restoration quality evaluation | assessed following the FDI criteria on a scale from 1 very good to 5 unacceptable | Baseline to 36 months |