Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth

University of North Carolina, Chapel Hill27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dental Restoration Failure of Marginal Integrity Dental Caries Unrepairable Overhanging of Dental Restorative Materials Poor Aesthetics of Existing Restoration

Interventions

Filtek Bulk Fill PosteriorDEVICE

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 UltraDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 \[Item 16\]

Time frame: Assessed immediately post restoration placement completion

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 \[Item 16\]

Time frame: Year 1

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 \[Item 16\]

Time frame: Year 2

Restoration Percent Success at Year 3

Time frame: Year 3

Restoration Percent Success at Year 5

Time frame: Year 5