Clinical Evaluation of a Bulk Fill Resin Composite

Ivoclar Vivadent AG1 site in 1 country39 target enrollmentDecember 1, 2017

ConditionsDental Caries Unsatisfactory or Defective Restoration of Tooth

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dental Caries
Sponsor: Ivoclar Vivadent AG
Enrollment: 39
Locations: 1
Primary Endpoint: Overall Survival Rate
Status: Completed
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 1, 2017

End Date

June 30, 2021

Last Updated

6 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ivoclar Vivadent AG

Responsible Party

Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Overall Survival Rate

Time Frame: 36 Month

Restorations were examined by a dentist

FDI 11 - Postoperative Hypersensitivity

Time Frame: 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

Time Frame: 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")