Back to resultsClinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth
Primary Purpose
Dental Restoration Failure of Marginal Integrity, Dental Caries, Unrepairable Overhanging of Dental Restorative Materials
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Filtek Bulk Fill Posterior
Filtek Supreme Ultra
Sponsored by
About this trial
This is an interventional treatment trial for Dental Restoration Failure of Marginal Integrity focused on measuring Adult dental care
Eligibility Criteria
Inclusion Criteria:
- Be 18 years of age and older
- Have a pair of similar cavities or failed dental fillings in vital permanent posterior teeth requiring treatment
- Be capable of giving written informed consent.
Exclusion Criteria:
- Have a self-reported history of any adverse reaction to materials of the types to be evaluated
- Have a medical or dental history that could possibly complicate the provision of the proposed treatment and/or influence the behavior and performance of the treatment in clinical service.
Sites / Locations
- University of North Carolina at Chapel Hill School of Dentistry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Posterior Composite Resin Restoration
Arm Description
Participants will receive two commercially available tooth-colored restorative materials used for direct restoration as per manufacturer's instructions.
Outcomes
Primary Outcome Measures
Restoration Percent Success at Day 1
The World Dental Federation (FDI) rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less:
A.Esthetic Properties Surface lustre [Item 1] Surface staining [Item 2] Color stability and translucency [Item 3] Anatomic form [Item 4] B.Functional Properties Fractures and retention [Item 5] Marginal adaptation [Item 6] Wear [Item 7] Contact point/food impact [Item 8] Radiographic examination [Item 9] Patient's view [Item 10] C.Biological Properties Postoperative (hyper)sensitivity and tooth vitality [Item 11] Recurrence of caries, erosion, abfraction [Item 12] Tooth integrity [Item 13] Periodontal response [Item 14] Adjacent mucosa [Item 15] Oral and general health [Item 16]
Restoration Percent Success at Year 1
The World Dental Federation (FDI) rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less:
A.Esthetic Properties
Surface lustre [Item 1]
Surface staining [Item 2]
Color stability and translucency [Item 3]
Anatomic form [Item 4]
B.Functional Properties
Fractures and retention [Item 5]
Marginal adaptation [Item 6]
Wear [Item 7]
Contact point/food impact [Item 8]
Radiographic examination [Item 9]
Patient's view [Item 10]
C.Biological Properties
Postoperative (hyper)sensitivity and tooth vitality [Item 11]
Recurrence of caries, erosion, abfraction [Item 12]
Tooth integrity [Item 13]
Periodontal response [Item 14]
Adjacent mucosa [Item 15]
Oral and general health [Item 16]
Restoration Percent Success at Year 2
The FDI rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less:
A.Esthetic Properties
Surface lustre [Item 1]
Surface staining [Item 2]
Color stability and translucency [Item 3]
Anatomic form [Item 4]
B.Functional Properties
Fractures and retention [Item 5]
Marginal adaptation [Item 6]
Wear [Item 7]
Contact point/food impact [Item 8]
Radiographic examination [Item 9]
Patient's view [Item 10]
C.Biological Properties
Postoperative (hyper)sensitivity and tooth vitality [Item 11]
Recurrence of caries, erosion, abfraction [Item 12]
Tooth integrity [Item 13]
Periodontal response [Item 14]
Adjacent mucosa [Item 15]
Oral and general health [Item 16]
Restoration Percent Success at Year 3
The FDI rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less:
A.Esthetic Properties
Surface lustre [Item 1]
Surface staining [Item 2]
Color stability and translucency [Item 3]
Anatomic form [Item 4]
B.Functional Properties
Fractures and retention [Item 5]
Marginal adaptation [Item 6]
Wear [Item 7]
Contact point/food impact [Item 8]
Radiographic examination [Item 9]
Patient's view [Item 10]
C.Biological Properties
Postoperative (hyper)sensitivity and tooth vitality [Item 11]
Recurrence of caries, erosion, abfraction [Item 12]
Tooth integrity [Item 13]
Periodontal response [Item 14]
Adjacent mucosa [Item 15]
Oral and general health [Item 16]
Restoration Percent Success at Year 5
The FDI rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less:
A.Esthetic Properties
Surface lustre [Item 1]
Surface staining [Item 2]
Color stability and translucency [Item 3]
Anatomic form [Item 4]
B.Functional Properties
Fractures and retention [Item 5]
Marginal adaptation [Item 6]
Wear [Item 7]
Contact point/food impact [Item 8]
Radiographic examination [Item 9]
Patient's view [Item 10]
C.Biological Properties
Postoperative (hyper)sensitivity and tooth vitality [Item 11]
Recurrence of caries, erosion, abfraction [Item 12]
Tooth integrity [Item 13]
Periodontal response [Item 14]
Adjacent mucosa [Item 15]
Oral and general health [Item 16]
Secondary Outcome Measures
Full Information
NCT ID
NCT02572570
First Posted
September 21, 2015
Last Updated
November 23, 2020
Sponsor
University of North Carolina, Chapel Hill
Collaborators
3M ESPE
1. Study Identification
Unique Protocol Identification Number
NCT02572570
Brief Title
Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth
Official Title
Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Attrition rate complicated by COVID-19 led to termination.
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 5, 2019 (Actual)
Study Completion Date
December 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
3M ESPE
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Polymerization shrinkage remains one of the primary disadvantages of composite resin restorative materials (tooth-colored fillings). To minimize the effects of polymerization shrinkage in the restorative treatment, the 3M ESPE company has developed a composite resin called Filtek Bulk Fill Posterior Restorative. Its decreased polymerization shrinkage and properties allow the material to be inserted in one single increment, expediting treatment. This clinical trial is designed to evaluate the performance of the new bulk fill composite resin in Class II (two-surface posterior) fillings.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Restoration Failure of Marginal Integrity, Dental Caries, Unrepairable Overhanging of Dental Restorative Materials, Poor Aesthetics of Existing Restoration, Secondary Dental Caries Associated With Failed or Defective Dental Restorations, Fractured Dental Restorative Materials Without Loss of Materials, Fracture of Dental Restorative Materials With Loss of Material
Keywords
Adult dental care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Posterior Composite Resin Restoration
Arm Type
Experimental
Arm Description
Participants will receive two commercially available tooth-colored restorative materials used for direct restoration as per manufacturer's instructions.
Intervention Type
Device
Intervention Name(s)
Filtek Bulk Fill Posterior
Other Intervention Name(s)
Dental filling
Intervention Description
Tooth (teeth) affected by dental caries or with an existing defective filling restored using the materials listed (Filtek Bulk Fill Posterior). Procedures done using local anesthesia and following ordinary restorative techniques.
Intervention Type
Device
Intervention Name(s)
Filtek Supreme Ultra
Other Intervention Name(s)
Dental filling
Intervention Description
Tooth (teeth) affected by dental caries or with an existing defective filling restored using the materials listed (Filtek Supreme Ultra). Procedures done using local anesthesia and following ordinary restorative techniques.
Primary Outcome Measure Information:
Title
Restoration Percent Success at Day 1
Description
The World Dental Federation (FDI) rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less:
A.Esthetic Properties Surface lustre [Item 1] Surface staining [Item 2] Color stability and translucency [Item 3] Anatomic form [Item 4] B.Functional Properties Fractures and retention [Item 5] Marginal adaptation [Item 6] Wear [Item 7] Contact point/food impact [Item 8] Radiographic examination [Item 9] Patient's view [Item 10] C.Biological Properties Postoperative (hyper)sensitivity and tooth vitality [Item 11] Recurrence of caries, erosion, abfraction [Item 12] Tooth integrity [Item 13] Periodontal response [Item 14] Adjacent mucosa [Item 15] Oral and general health [Item 16]
Time Frame
Assessed immediately post restoration placement completion
Title
Restoration Percent Success at Year 1
Description
The World Dental Federation (FDI) rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less:
A.Esthetic Properties
Surface lustre [Item 1]
Surface staining [Item 2]
Color stability and translucency [Item 3]
Anatomic form [Item 4]
B.Functional Properties
Fractures and retention [Item 5]
Marginal adaptation [Item 6]
Wear [Item 7]
Contact point/food impact [Item 8]
Radiographic examination [Item 9]
Patient's view [Item 10]
C.Biological Properties
Postoperative (hyper)sensitivity and tooth vitality [Item 11]
Recurrence of caries, erosion, abfraction [Item 12]
Tooth integrity [Item 13]
Periodontal response [Item 14]
Adjacent mucosa [Item 15]
Oral and general health [Item 16]
Time Frame
Year 1
Title
Restoration Percent Success at Year 2
Description
The FDI rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less:
A.Esthetic Properties
Surface lustre [Item 1]
Surface staining [Item 2]
Color stability and translucency [Item 3]
Anatomic form [Item 4]
B.Functional Properties
Fractures and retention [Item 5]
Marginal adaptation [Item 6]
Wear [Item 7]
Contact point/food impact [Item 8]
Radiographic examination [Item 9]
Patient's view [Item 10]
C.Biological Properties
Postoperative (hyper)sensitivity and tooth vitality [Item 11]
Recurrence of caries, erosion, abfraction [Item 12]
Tooth integrity [Item 13]
Periodontal response [Item 14]
Adjacent mucosa [Item 15]
Oral and general health [Item 16]
Time Frame
Year 2
Title
Restoration Percent Success at Year 3
Description
The FDI rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less:
A.Esthetic Properties
Surface lustre [Item 1]
Surface staining [Item 2]
Color stability and translucency [Item 3]
Anatomic form [Item 4]
B.Functional Properties
Fractures and retention [Item 5]
Marginal adaptation [Item 6]
Wear [Item 7]
Contact point/food impact [Item 8]
Radiographic examination [Item 9]
Patient's view [Item 10]
C.Biological Properties
Postoperative (hyper)sensitivity and tooth vitality [Item 11]
Recurrence of caries, erosion, abfraction [Item 12]
Tooth integrity [Item 13]
Periodontal response [Item 14]
Adjacent mucosa [Item 15]
Oral and general health [Item 16]
Time Frame
Year 3
Title
Restoration Percent Success at Year 5
Description
The FDI rates 16 categories on a scale of 1 to 5 with 1 being "Clinically Excellent" and 5 being "Clinically Poor". Scores 1-3 were considered clinically acceptable while scores 4 and 5 were considered failures. Cases were considered successful if each of the 16 following FDI criteria presented an individual score of 3 or less:
A.Esthetic Properties
Surface lustre [Item 1]
Surface staining [Item 2]
Color stability and translucency [Item 3]
Anatomic form [Item 4]
B.Functional Properties
Fractures and retention [Item 5]
Marginal adaptation [Item 6]
Wear [Item 7]
Contact point/food impact [Item 8]
Radiographic examination [Item 9]
Patient's view [Item 10]
C.Biological Properties
Postoperative (hyper)sensitivity and tooth vitality [Item 11]
Recurrence of caries, erosion, abfraction [Item 12]
Tooth integrity [Item 13]
Periodontal response [Item 14]
Adjacent mucosa [Item 15]
Oral and general health [Item 16]
Time Frame
Year 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Be 18 years of age and older
Have a pair of similar cavities or failed dental fillings in vital permanent posterior teeth requiring treatment
Be capable of giving written informed consent.
Exclusion Criteria:
Have a self-reported history of any adverse reaction to materials of the types to be evaluated
Have a medical or dental history that could possibly complicate the provision of the proposed treatment and/or influence the behavior and performance of the treatment in clinical service.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rick Walter, DDS
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill School of Dentistry
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth
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