Clinical Evaluation of a Bulk Fill Resin Composite

NCT04686422 | Completed Results FDA Device

• 1 other identifier: LL3079573
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Unsatisfactory or Defective Restoration of Tooth

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (5)

• FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)

  Baseline

• FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)

  6 Month

• FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)

  12 Month

• FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)

  24 Month

• FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)

  36 Month

Study Arms (1)

Tetric PowerFill Class I and II restorations

EXPERIMENTAL

Device: Tetric PowerFill

Interventions

Tetric PowerFill DEVICE

Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.

Tetric PowerFill Class I and II restorations

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• % of the restorations Class II (minimum) and 25% Class I
• Each Class II will have at least one proximal contact
• % 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

You may not qualify if:

• If they have an allergy to ingredients of the materials under investigation (monomers)
• 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

Sponsors & Collaborators

• Ivoclar Vivadent AG: lead

Study Sites (1)

UAB School of Dentistry

Birmingham, Alabama, 35294-0007, United States

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Team Leader Study Management
• Organization: Ivoclar Vivadent AG

patrizia.elkuch-hoch@ivoclar.com

+4232353780

Study Officials

• Nathaniel Lawson, Dr

  UAB School of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: December 1, 2017
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: October 23, 2025
• Results First Posted: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)