Trial Outcomes & Findings for Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth (NCT NCT02572570)

Last Updated: 2020-12-19

Results Overview

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 \[Item 16\]

Recruitment status

TERMINATED

Study phase

Target enrollment

27 participants

Primary outcome timeframe

Assessed immediately post restoration placement completion

Results posted on

2020-12-19

Participant Flow

Unit of analysis: Restoration

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	27 64
Overall Study Filtek Bulk Fill Posterior	27 32
Overall Study Filtek Supreme Ultra	27 32
Overall Study 1 Year Follow-Up	20 46
Overall Study 2 Year Follow-Up	13 34
Overall Study 3 Year Follow-Up	5 12
Overall Study 5 Year Follow-Up	0 0
Overall Study COMPLETED	0 0
Overall Study NOT COMPLETED	27 64

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Study Terminated	27

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Posterior Composite Resin Restoration n=64 Restorations 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed immediately post restoration placement completion

Outcome measures

Outcome measures
Measure	Filtek Bulk Fill Posterior n=32 Restorations Dental material for posterior restoration placed in increments up to 5 mm in thickness.	Filtek Supreme Ultra n=32 Restorations Dental material for posterior restoration placed in increments up to 2 mm in thickness.
Restoration Percent Success at Day 1	100 percentage of scores =/<3	100 percentage of scores =/<3

PRIMARY outcome

Timeframe: Year 1

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

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 \[Item 16\]

Outcome measures

Outcome measures
Measure	Filtek Bulk Fill Posterior n=23 Restorations Dental material for posterior restoration placed in increments up to 5 mm in thickness.	Filtek Supreme Ultra n=23 Restorations Dental material for posterior restoration placed in increments up to 2 mm in thickness.
Restoration Percent Success at Year 1 Esthetic Properties	100 percentage of scores =/<3	96 percentage of scores =/<3
Restoration Percent Success at Year 1 Functional Properties	96 percentage of scores =/<3	96 percentage of scores =/<3
Restoration Percent Success at Year 1 Biological Properties	96 percentage of scores =/<3	100 percentage of scores =/<3

PRIMARY outcome

Timeframe: Year 2

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

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 \[Item 16\]

Outcome measures

Outcome measures
Measure	Filtek Bulk Fill Posterior n=17 Restorations Dental material for posterior restoration placed in increments up to 5 mm in thickness.	Filtek Supreme Ultra n=17 Restorations Dental material for posterior restoration placed in increments up to 2 mm in thickness.
Restoration Percent Success at Year 2 Esthetic Properties	94 percentage of scores =/<3	100 percentage of scores =/<3
Restoration Percent Success at Year 2 Functional Properties	100 percentage of scores =/<3	88 percentage of scores =/<3
Restoration Percent Success at Year 2 Biological Properties	100 percentage of scores =/<3	100 percentage of scores =/<3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Filtek Bulk Fill Posterior n=6 Restorations Dental material for posterior restoration placed in increments up to 5 mm in thickness.	Filtek Supreme Ultra n=6 Restorations Dental material for posterior restoration placed in increments up to 2 mm in thickness.
Restoration Percent Success at Year 3 Esthetic Properties	67 percentage of scores =/<3	100 percentage of scores =/<3
Restoration Percent Success at Year 3 Functional Properties	100 percentage of scores =/<3	67 percentage of scores =/<3
Restoration Percent Success at Year 3 Biological Properties	100 percentage of scores =/<3	100 percentage of scores =/<3

PRIMARY outcome

Timeframe: Year 5

Population: Data not collected because study was terminated.

Outcome measures

Outcome data not reported

Adverse Events

Filtek Bulk Fill Posterior

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Filtek Supreme Ultra

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

All Participants

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Filtek Bulk Fill Posterior n=27 participants at risk Dental material for posterior restoration placed in increments up to 5 mm in thickness.	Filtek Supreme Ultra n=27 participants at risk Dental material for posterior restoration placed in increments up to 2 mm in thickness.	All Participants n=27 participants at risk Includes all participants, who received both interventions.
Musculoskeletal and connective tissue disorders Rotator Cuff Injury	3.7% 1/27 • Number of events 1 • 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.	3.7% 1/27 • Number of events 1 • 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.	3.7% 1/27 • Number of events 1 • 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.
Surgical and medical procedures Appendicitis	3.7% 1/27 • Number of events 1 • 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.	3.7% 1/27 • Number of events 1 • 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.	3.7% 1/27 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pneumonia	3.7% 1/27 • Number of events 1 • 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.	3.7% 1/27 • Number of events 1 • 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.	3.7% 1/27 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	Filtek Bulk Fill Posterior n=27 participants at risk Dental material for posterior restoration placed in increments up to 5 mm in thickness.	Filtek Supreme Ultra n=27 participants at risk Dental material for posterior restoration placed in increments up to 2 mm in thickness.	All Participants n=27 participants at risk Includes all participants, who received both interventions.
Injury, poisoning and procedural complications Cracked Tooth	3.7% 1/27 • Number of events 1 • 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.	3.7% 1/27 • Number of events 1 • 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.	3.7% 1/27 • Number of events 1 • 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.
Injury, poisoning and procedural complications Tooth Sensitivity	7.4% 2/27 • Number of events 2 • 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.	3.7% 1/27 • Number of events 1 • 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.	7.4% 2/27 • Number of events 2 • 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.
Injury, poisoning and procedural complications Left-sided Facial Pain	3.7% 1/27 • Number of events 1 • 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.	3.7% 1/27 • Number of events 1 • 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.	3.7% 1/27 • Number of events 1 • 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.
Gastrointestinal disorders Acid Reflux	3.7% 1/27 • Number of events 1 • 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.	3.7% 1/27 • Number of events 1 • 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.	3.7% 1/27 • Number of events 1 • 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.
Infections and infestations Tooth Pain	3.7% 1/27 • Number of events 1 • 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.	3.7% 1/27 • Number of events 1 • 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.	3.7% 1/27 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Hypermobility of Joints	3.7% 1/27 • Number of events 1 • 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.	3.7% 1/27 • Number of events 1 • 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.	3.7% 1/27 • Number of events 1 • 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.

Additional Information

Ricardo Walter, DDS, MS

University of North Carolina at Chapel Hill

Phone: 9195373596

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place