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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02572570
Other study ID # 14-3097
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 2015
Est. completion date December 5, 2019

Study information

Verified date October 2020
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 27
Est. completion date December 5, 2019
Est. primary completion date December 5, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Dental Caries
  • Dental Restoration Failure of Marginal Integrity
  • Fracture of Dental Restorative Materials With Loss of Material
  • Fractured Dental Restorative Materials Without Loss of Materials
  • Poor Aesthetics of Existing Restoration
  • Secondary Dental Caries Associated With Failed or Defective Dental Restorations
  • Unrepairable Overhanging of Dental Restorative Materials

Intervention

Device:
Filtek Bulk Fill Posterior
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.
Filtek Supreme Ultra
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.

Locations

Country Name City State
United States University of North Carolina at Chapel Hill School of Dentistry Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill 3M ESPE

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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]
Assessed immediately post restoration placement completion
Primary 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]
Year 1
Primary 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]
Year 2
Primary 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]
Year 3
Primary 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]
Year 5
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