Not provided
Not provided
Not provided
Not provided
Not provided
Attrition rate complicated by COVID-19 led to termination.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| 3M ESPE | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posterior Composite Resin Restoration | Experimental | Participants will receive two commercially available tooth-colored restorative materials used for direct restoration as per manufacturer's instructions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filtek Bulk Fill Posterior | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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
B.Functional Properties
C.Biological Properties
| 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
B.Functional Properties
C.Biological Properties
|
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rick Walter, DDS | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill School of Dentistry | Chapel Hill | North Carolina | 27599 | United States |
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2015 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Filtek Supreme Ultra | Device | 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. |
|
|
| Year 2 |
| 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
B.Functional Properties
C.Biological Properties
| Year 3 |
| 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
B.Functional Properties
C.Biological Properties
| Year 5 |
| Filtek Bulk Fill Posterior |
|
| Filtek Supreme Ultra |
|
| 1 Year Follow-Up |
|
| 2 Year Follow-Up |
|
| 3 Year Follow-Up |
|
| 5 Year Follow-Up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Restorations |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
| |||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
| |||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
| |||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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] | Posted | Number | percentage of scores =/<3 | Assessed immediately post restoration placement completion | Restorations | Restorations |
|
|
| ||||||||||||||||||||||||||||||
| 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
B.Functional Properties
C.Biological Properties
| Esthetic and Functional Property data not collected for 1 restoration that was replaced due to sensitivity prior to assessment visit. | Posted | Number | percentage of scores =/<3 | Year 1 | Restorations | Restorations |
| |||||||||||||||||||||||||||||||
| 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
B.Functional Properties
C.Biological Properties
| Esthetic and Biological Property data not collected for 1 restoration due to tooth fracture resulting in full coverage restoration. | Posted | Number | percentage of scores =/<3 | Year 2 | Restorations | Restorations |
| |||||||||||||||||||||||||||||||
| 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
B.Functional Properties
C.Biological Properties
| Esthetic and Biological Property data not collected for 1 restoration due to tooth fracture resulting in full coverage restoration prior to Year 2 assessment. | Posted | Number | percentage of scores =/<3 | Year 3 | Restorations | Restorations |
| |||||||||||||||||||||||||||||||
| 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
B.Functional Properties
C.Biological Properties
| Data not collected because study was terminated. | Posted | Year 5 | Restorations | Restorations |
|
From time of restoration through last follow-up visit, a planned total of up to 5 years although the trial was terminated early, thus the maximum participant follow-up was through Year 3.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Filtek Bulk Fill Posterior | Dental material for posterior restoration placed in increments up to 5 mm in thickness. | 0 | 27 | 3 | 27 | 7 | 27 |
| EG001 | Filtek Supreme Ultra | Dental material for posterior restoration placed in increments up to 2 mm in thickness. | 0 | 27 | 3 | 27 | 6 | 27 |
| EG002 | All Participants | Includes all participants, who received both interventions. | 0 | 27 | 3 | 27 | 7 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rotator Cuff Injury | Musculoskeletal and connective tissue disorders | Systematic Assessment | Surgery required |
| |
| Appendicitis | Surgical and medical procedures | Systematic Assessment | Surgical intervention required |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cracked Tooth | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Tooth Sensitivity | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Left-sided Facial Pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Acid Reflux | Gastrointestinal disorders | Systematic Assessment |
| ||
| Tooth Pain | Infections and infestations | Systematic Assessment |
| ||
| Hypermobility of Joints | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ricardo Walter, DDS, MS | University of North Carolina at Chapel Hill | 9195373596 | walterr@unc.edu |
| Oct 20, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
| Restorations |
|
|
|
|
|
|
|
|