Clinical Evaluation of a Bulk Fill Resin Composite

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries; Unsatisfactory or Defective Restoration of Tooth
• Intervention / Treatment: Device: Tetric PowerFill

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0007
      • UAB School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FDI 11 - 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
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
Overall Survival Rate	Restorations were examined by a dentist	Baseline
FDI 11 - 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"	6 Month
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")	6 Month
Overall Survival Rate	Restorations were examined by a dentist	6 Month
FDI 11 - 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"	12 Month
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")	12 Month
Overall Survival Rate	Restorations were examined by a dentist	12 Month
FDI 11 - 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"	24 Month
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")	24 Month
Overall Survival Rate	Restorations were examined by a dentist	24 Month
FDI 11 - 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"	36 Month
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")	36 Month
Overall Survival Rate	Restorations were examined by a dentist	36 Month

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
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"	6 Month
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"	12 Month
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"	24 Month
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"	36 Month

Collaborators and Investigators

• Sponsor: Ivoclar Vivadent AG
• Investigators: Principal Investigator: Nathaniel Lawson, Dr, UAB School of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Estimated): October 23, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: LL3079573

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No