Clinical Evaluation of a Bulk Fill Resin Composite

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Tetric PowerFill Class I and II restorations	Tetric PowerFill	-

Primary Outcome Measures

Name	Time	Method
Overall Survival Rate	36 Month	Restorations were examined by a dentist
FDI 11 - Postoperative Hypersensitivity	36 Month	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"
Pulp Integrity	36 Month	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")

Secondary Outcome Measures

Name	Time	Method
FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)	36 Month	assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"