Prospective, Split-mouth, Comparative Study to Compare Clinical Outcomes of Two Different Posterior Composite

NCT04708223 | Completed Results FDA Device

• 1 other identifier: LL3274680
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this 2-year split mouth comparative study, a randomized controlled study, is to determine whether the simplified placement procedure of the ultra-rapid polymerizing Tetric PowerFlow/ Tetric PowerFill with a reduced light polymerization time (3 s), yields the same clin-ical results as widely used commercially available dental composites (Tetric EvoCeram Bulk Fill, Tetric EvoFlow Bulk Fill) requiring up to 40 seconds of light polymerization time.

Conditions

Caries; Defective Tooth Restorations

Outcome Measures

Primary Outcomes (5)

• Number of Teeth Analyzed According to 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 Fédération dentaire internationale (FDI) criteria on a scale from 1 "very good" to 5 "unacceptable"

  Baseline

• Number of Teeth Analyzed According to 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

• Number of Teeth Analyzed According to 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

• Number of Teeth Analyzed According to 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

• Number of Teeth Analyzed According to 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

Secondary Outcomes (5)

• Restoration Quality Evaluation

  Baseline

• Restoration Quality Evaluation

  6 Month

• Restoration Quality Evaluation

  12 Month

• Restoration Quality Evaluation

  24 Month

• Restoration Quality Evaluation

  36 Month

Study Arms (2)

Fast-curing composites

EXPERIMENTAL

Device: Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow)

Conventionally applied composites

OTHER

Device: Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill)

Interventions

Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow) DEVICE

Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.

Fast-curing composites

Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill) DEVICE

Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.

Conventionally applied composites

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each subject must need at least 2 restorations in a vital posterior tooth (in different quadrants)
• Restorations may be indicated for caries removal and restoration, replacement of defec-tive restorations (i.e. fractured, stained, unaesthetic), or requested replacement of un-aesthetic restorations.
• Must have given written consent to participate in the trial
• Must be available for the required follow-up visits over 2 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
• One, two or three surfaces per restoration
• 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 with evidence of bilateral posterior tooth contacts
• Teeth that require one or no cuspal build-ups
• Vital tooth
• Preoperative sensibility on the teeth to be treated at maximum 3 on visual analog scale (10 = maximum)

You may not qualify if:

• Allergies to ingredients of the materials under investigation (monomers)
• Have medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or are immunocompromised) or disabilities rendering them unable to tolerate the time required to complete the restorations or to provide adequate oral hygiene
• Suffer from xerostomia either by taking medications known to produce xerostomia or those with radiation induced xerostomia or Sjogren's syndrome subjects
• 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
• Patients reporting having severe grinding/bruxing or clenching or in need of TMJ-related therapy
• Have tooth with exposed pulp during preparation or caries removal or require indirect pulp capping
• If the working field cannot be maintained in a dry state for treatment

Sponsors & Collaborators

• Ivoclar Vivadent AG: lead

Study Sites (1)

University of Illinois College of Dentistry

Chicago, Illinois, 60612, United States

Location

Results Point of Contact

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

patrizia.elkuch-hoch@ivoclar.com

+4232353780

Study Officials

• Lyndon F. Cooper, Dr.

  University of Illinois College 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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Split-mouth Design

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: January 13, 2021
• Study Start: September 1, 2018
• Primary Completion: May 16, 2022
• Study Completion: May 16, 2022
• Last Updated: October 23, 2025
• Results First Posted: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)