Dental Caries, Dental Restoration Failure of Marginal Integrity, Fractured Dental Restorative Materials Without Loss of Materials, Fracture of Dental Restorative Materials With Loss of Material, Poor Aesthetics of Existing Restoration, Secondary Dental Caries Associated With Failed or Defective Dental Restorations, Unrepairable Overhanging of Dental Restorative Materials
Conditions
Keywords
Adult dental care
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.
Interventions
DEVICEFiltek 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.
DEVICEFiltek 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.
Sponsors
3M ESPE
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 \[Item 16\] |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Posterior Composite Resin Restoration Posterior teeth were restored with two tooth-colored restorative materials using different techniques. Increments that were either up to 2 mm or 5 mm were placed. Twenty-two participants received one restoration and five participants received two restorations of each material, for a total of 64 restorations in 27 patients. | 27 |
| Posterior Composite Resin Restoration Posterior teeth were restored with two tooth-colored restorative materials using different techniques. Increments that were either up to 2 mm or 5 mm were placed. Twenty-two participants received one restoration and five participants received two restorations of each material, for a total of 64 restorations in 27 patients. | 64 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study Terminated | 27 |
Baseline characteristics
| Characteristic | Posterior Composite Resin Restoration |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 27 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 7 / 27 | 6 / 27 | 7 / 27 |
| serious Total, serious adverse events | 3 / 27 | 3 / 27 | 3 / 27 |
Outcome results
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 \[Item 16\]
Time frame: Assessed immediately post restoration placement completion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Filtek Bulk Fill Posterior | Restoration Percent Success at Day 1 | 100 percentage of scores =/<3 |
| Filtek Supreme Ultra | Restoration Percent Success at Day 1 | 100 percentage of scores =/<3 |
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 \[Item 16\]
Time frame: Year 1
Population: Esthetic and Functional Property data not collected for 1 restoration that was replaced due to sensitivity prior to assessment visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filtek Bulk Fill Posterior | Restoration Percent Success at Year 1 | Esthetic Properties | 100 percentage of scores =/<3 |
| Filtek Bulk Fill Posterior | Restoration Percent Success at Year 1 | Functional Properties | 96 percentage of scores =/<3 |
| Filtek Bulk Fill Posterior | Restoration Percent Success at Year 1 | Biological Properties | 96 percentage of scores =/<3 |
| Filtek Supreme Ultra | Restoration Percent Success at Year 1 | Esthetic Properties | 96 percentage of scores =/<3 |
| Filtek Supreme Ultra | Restoration Percent Success at Year 1 | Functional Properties | 96 percentage of scores =/<3 |
| Filtek Supreme Ultra | Restoration Percent Success at Year 1 | Biological Properties | 100 percentage of scores =/<3 |
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 \[Item 16\]
Time frame: Year 2
Population: Esthetic and Biological Property data not collected for 1 restoration due to tooth fracture resulting in full coverage restoration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filtek Bulk Fill Posterior | Restoration Percent Success at Year 2 | Esthetic Properties | 94 percentage of scores =/<3 |
| Filtek Bulk Fill Posterior | Restoration Percent Success at Year 2 | Functional Properties | 100 percentage of scores =/<3 |
| Filtek Bulk Fill Posterior | Restoration Percent Success at Year 2 | Biological Properties | 100 percentage of scores =/<3 |
| Filtek Supreme Ultra | Restoration Percent Success at Year 2 | Esthetic Properties | 100 percentage of scores =/<3 |
| Filtek Supreme Ultra | Restoration Percent Success at Year 2 | Functional Properties | 88 percentage of scores =/<3 |
| Filtek Supreme Ultra | Restoration Percent Success at Year 2 | Biological Properties | 100 percentage of scores =/<3 |
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 \[Item 16\]
Time frame: Year 3
Population: Esthetic and Biological Property data not collected for 1 restoration due to tooth fracture resulting in full coverage restoration prior to Year 2 assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Filtek Bulk Fill Posterior | Restoration Percent Success at Year 3 | Esthetic Properties | 67 percentage of scores =/<3 |
| Filtek Bulk Fill Posterior | Restoration Percent Success at Year 3 | Functional Properties | 100 percentage of scores =/<3 |
| Filtek Bulk Fill Posterior | Restoration Percent Success at Year 3 | Biological Properties | 100 percentage of scores =/<3 |
| Filtek Supreme Ultra | Restoration Percent Success at Year 3 | Esthetic Properties | 100 percentage of scores =/<3 |
| Filtek Supreme Ultra | Restoration Percent Success at Year 3 | Functional Properties | 67 percentage of scores =/<3 |
| Filtek Supreme Ultra | Restoration Percent Success at Year 3 | Biological Properties | 100 percentage of scores =/<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 \[Item 16\]
Time frame: Year 5
Population: Data not collected because study was terminated.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Restoration Percent Success at Year 5 | Esthetic Properties | — |
| Unknown | Restoration Percent Success at Year 5 | Functional Properties | — |
| Unknown | Restoration Percent Success at Year 5 | Biological Properties | — |