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Clinical Evaluation of a Bulk Fill Resin Composite

Primary Purpose

Dental Caries, Unsatisfactory or Defective Restoration of Tooth

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tetric PowerFill
Sponsored by
Ivoclar Vivadent AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UAB School of Dentistry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tetric PowerFill Class I and II restorations

Arm Description

Outcomes

Primary Outcome Measures

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"
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")
Overall survival rate
Kaplan-Meier survival analysis will be performed to estimate the lifetime of the material based on clinical failures

Secondary Outcome Measures

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"

Full Information

First Posted
December 22, 2020
Last Updated
April 8, 2022
Sponsor
Ivoclar Vivadent AG
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1. Study Identification

Unique Protocol Identification Number
NCT04686422
Brief Title
Clinical Evaluation of a Bulk Fill Resin Composite
Official Title
Clinical Evaluation of a Bulk Fill Resin Composite
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ivoclar Vivadent AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Unsatisfactory or Defective Restoration of Tooth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tetric PowerFill Class I and II restorations
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Tetric PowerFill
Intervention Description
Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
Primary Outcome Measure Information:
Title
postoperative hypersensitivity
Description
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"
Time Frame
Baseline to 36 months
Title
Pulp integrity
Description
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")
Time Frame
Baseline to 36 months
Title
Overall survival rate
Description
Kaplan-Meier survival analysis will be performed to estimate the lifetime of the material based on clinical failures
Time Frame
36 months
Secondary Outcome Measure Information:
Title
FDI criteria (Surface lustre, surface staining, colour match, material fracture, occlusal wear, tooth integrity)
Description
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
Time Frame
Baseline to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathaniel Lawson, Dr
Organizational Affiliation
UAB School of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB School of Dentistry
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0007
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Evaluation of a Bulk Fill Resin Composite

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