Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth
Study Overview
Status
Conditions
- Dental Caries
- Dental Restoration Failure of Marginal Integrity
- 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
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill School of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Posterior Composite Resin Restoration
Participants will receive two commercially available tooth-colored restorative materials used for direct restoration as per manufacturer's instructions.
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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.
Other Names:
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Restoration Percent Success at Day 1
Time Frame: Assessed immediately post restoration placement completion
|
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] |
Assessed immediately post restoration placement completion
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Restoration Percent Success at Year 1
Time Frame: 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
B.Functional Properties
C.Biological Properties
|
Year 1
|
|
Restoration Percent Success at Year 2
Time Frame: 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
B.Functional Properties
C.Biological Properties
|
Year 2
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Restoration Percent Success at Year 3
Time Frame: 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
B.Functional Properties
C.Biological Properties
|
Year 3
|
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Restoration Percent Success at Year 5
Time Frame: 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
B.Functional Properties
C.Biological Properties
|
Year 5
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Rick Walter, DDS, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-3097
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