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

Not Applicable

Terminated

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

Interventions: Device: Filtek Bulk Fill Posterior
Device: Filtek Supreme Ultra

Registration Number: NCT02572570

Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 27

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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Posterior Composite Resin Restoration	Filtek Supreme Ultra	Participants will receive two commercially available tooth-colored restorative materials used for direct restoration as per manufacturer's instructions.
Posterior Composite Resin Restoration	Filtek Bulk Fill Posterior	Participants will receive two commercially available tooth-colored restorative materials used for direct restoration as per manufacturer's instructions.

Primary Outcome Measures

Name	Time	Method
Restoration Percent Success at Year 1	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 Day 1	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 \[Item 16\]
Restoration Percent Success at Year 2	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	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	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 \[Item 16\]