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

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02572570
• Collaborator: 3M ESPE (Industry)
• Enrollment: 27
• Location: 1
• Arm: 1
• Duration (Months): 48.1
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Restoration Failure of Marginal Integrity; Dental Caries; Unrepairable Overhanging of Dental Restorative Materials; Poor Aesthetics of Existing Restoration; Secondary Dental Caries Associated With Failed or Defective Dental Restorations; Fractured Dental Restorative Materials Without Loss of Materials; Fracture of Dental Restorative Materials With Loss of Material	Device: Filtek Bulk Fill Posterior; Device: Filtek Supreme Ultra	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Dec 5, 2019
• Actual Study Completion Date: Dec 5, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Posterior Composite Resin Restoration Participants will receive two commercially available tooth-colored restorative materials used for direct restoration as per manufacturer's instructions.

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.; Other Names: Dental filling ; Device: 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.; Other Names: Dental filling

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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]

3. 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]

4. 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]

5. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina at Chapel Hill School of Dentistry	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

• University of North Carolina, Chapel Hill
• 3M ESPE

Investigators

• Principal Investigator: Rick Walter, DDS, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 20, 2015

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT02572570
• Other Study ID Numbers: 14-3097
• First Posted: Oct 9, 2015
• Last Update Posted: Dec 19, 2020
• Last Verified: Oct 1, 2020

• Keywords provided by University of North Carolina, Chapel Hill: Adult dental care
• Additional relevant MeSH terms: Dental Caries

Study Results

Participant Flow

Arm/Group Title	Posterior Composite Resin Restoration
Arm/Group Description	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.
Period Title: Overall Study
STARTED	27
Filtek Bulk Fill Posterior	27
Filtek Supreme Ultra	27
1 Year Follow-Up	20
2 Year Follow-Up	13
3 Year Follow-Up	5
5 Year Follow-Up	0
COMPLETED	0
NOT COMPLETED	27

Baseline Characteristics

Arm/Group Title	Posterior Composite Resin Restoration
Arm/Group Description	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.
Overall Participants	27
Overall Restorations	64
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	27 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	19 70.4%
Male	8 29.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 7.4%
Not Hispanic or Latino	25 92.6%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 3.7%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	4 14.8%
White	21 77.8%
More than one race	0 0%
Unknown or Not Reported	1 3.7%
Region of Enrollment (Count of Participants)
United States	27 100%

Outcome Measures

1. Primary Outcome

Title	Restoration Percent Success at Day 1
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Filtek Bulk Fill Posterior	Filtek Supreme Ultra
Arm/Group Description	Dental material for posterior restoration placed in increments up to 5 mm in thickness.	Dental material for posterior restoration placed in increments up to 2 mm in thickness.
Measure Participants	27	27
Measure Restorations	32	32
Number [percentage of scores =/<3]	100	100

2. Primary Outcome

Title	Restoration Percent Success at Year 1
Description	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

Outcome Measure Data

Analysis Population Description

Esthetic and Functional Property data not collected for 1 restoration that was replaced due to sensitivity prior to assessment visit.

Arm/Group Title	Filtek Bulk Fill Posterior	Filtek Supreme Ultra
Arm/Group Description	Dental material for posterior restoration placed in increments up to 5 mm in thickness.	Dental material for posterior restoration placed in increments up to 2 mm in thickness.
Measure Participants	20	20
Measure Restorations	23	23
Esthetic Properties	100	96
Functional Properties	96	96
Biological Properties	96	100

3. Primary Outcome

Title	Restoration Percent Success at Year 2
Description	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

Outcome Measure Data

Analysis Population Description

Esthetic and Biological Property data not collected for 1 restoration due to tooth fracture resulting in full coverage restoration.

Arm/Group Title	Filtek Bulk Fill Posterior	Filtek Supreme Ultra
Arm/Group Description	Dental material for posterior restoration placed in increments up to 5 mm in thickness.	Dental material for posterior restoration placed in increments up to 2 mm in thickness.
Measure Participants	13	13
Measure Restorations	17	17
Esthetic Properties	94	100
Functional Properties	100	88
Biological Properties	100	100

4. Primary Outcome

Title	Restoration Percent Success at Year 3
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Filtek Bulk Fill Posterior	Filtek Supreme Ultra
Arm/Group Description	Dental material for posterior restoration placed in increments up to 5 mm in thickness.	Dental material for posterior restoration placed in increments up to 2 mm in thickness.
Measure Participants	5	5
Measure Restorations	6	6
Esthetic Properties	67	100
Functional Properties	100	67
Biological Properties	100	100

5. Primary Outcome

Title	Restoration Percent Success at Year 5
Description	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

Outcome Measure Data

Analysis Population Description

Data not collected because study was terminated.

Arm/Group Title	Filtek Bulk Fill Posterior	Filtek Supreme Ultra
Arm/Group Description	Dental material for posterior restoration placed in increments up to 5 mm in thickness.	Dental material for posterior restoration placed in increments up to 2 mm in thickness.
Measure Participants	0	0
Measure Restorations	0	0

Adverse Events

Time Frame	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.
Arm/Group Title	Filtek Bulk Fill Posterior		Filtek Supreme Ultra		All Participants
Arm/Group Description	Dental material for posterior restoration placed in increments up to 5 mm in thickness.		Dental material for posterior restoration placed in increments up to 2 mm in thickness.		Includes all participants, who received both interventions.
All Cause Mortality
	Filtek Bulk Fill Posterior		Filtek Supreme Ultra		All Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/27 (0%)		0/27 (0%)
Serious Adverse Events
	Filtek Bulk Fill Posterior		Filtek Supreme Ultra		All Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/27 (11.1%)		3/27 (11.1%)		3/27 (11.1%)
Musculoskeletal and connective tissue disorders
Rotator Cuff Injury	1/27 (3.7%)	1	1/27 (3.7%)	1	1/27 (3.7%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonia	1/27 (3.7%)	1	1/27 (3.7%)	1	1/27 (3.7%)	1
Surgical and medical procedures
Appendicitis	1/27 (3.7%)	1	1/27 (3.7%)	1	1/27 (3.7%)	1
Other (Not Including Serious) Adverse Events
	Filtek Bulk Fill Posterior		Filtek Supreme Ultra		All Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/27 (25.9%)		6/27 (22.2%)		7/27 (25.9%)
Gastrointestinal disorders
Acid Reflux	1/27 (3.7%)	1	1/27 (3.7%)	1	1/27 (3.7%)	1
Infections and infestations
Tooth Pain	1/27 (3.7%)	1	1/27 (3.7%)	1	1/27 (3.7%)	1
Injury, poisoning and procedural complications
Cracked Tooth	1/27 (3.7%)	1	1/27 (3.7%)	1	1/27 (3.7%)	1
Tooth Sensitivity	2/27 (7.4%)	2	1/27 (3.7%)	1	2/27 (7.4%)	2
Left-sided Facial Pain	1/27 (3.7%)	1	1/27 (3.7%)	1	1/27 (3.7%)	1
Musculoskeletal and connective tissue disorders
Hypermobility of Joints	1/27 (3.7%)	1	1/27 (3.7%)	1	1/27 (3.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.