Clinical Evaluation of a Bulk Fill Resin Composite

NCT ID: NCT04686422

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2021-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tetric PowerFill Class I and II restorations

Group Type: EXPERIMENTAL

Tetric PowerFill

Intervention Type: DEVICE

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

Interventions

Tetric PowerFill

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

Intervention Type: DEVICE

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
• Must have 20 or more teeth

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ivoclar Vivadent AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathaniel Lawson, Dr

Role: PRINCIPAL_INVESTIGATOR

UAB School of Dentistry

Locations

UAB School of Dentistry

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

LL3079573

Identifier Type: -

Identifier Source: org_study_id