Trial Outcomes & Findings for Clinical Performance of Incremental and Bulk Fill Composites in Class II Restorations (NCT NCT02889835)

NCT ID: NCT02889835

Last Updated: 2024-10-01

Results Overview

Percentage of restorations that survived (percent clinically acceptable per FDI criteria) over 36 months.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 53 participants
• Primary outcome timeframe: 36 Months
• Results posted on: 2024-10-01

Participant Flow

53 subjects were evaluated at baseline (3 subjects with 2 sets of restorations). "Number Started" will be greater than the Protocol Enrollment and cannot be revised, however, this is acceptable for split-person studies.

Unit of analysis: Teeth

Participant milestones

Measure	Universal Composite This is a split-mouth design with each subject receiving one or two replicates of each of three restorative dental-filling materials: 1) Supreme Universal Composite, 2) Supreme Flowable Composite, and/or, 3) Bulk-fill Composite	Flowable Composite This is a split-mouth design with each subject receiving one or two replicates of each of three restorative dental-filling materials: 1) Supreme Universal Composite, 2) Supreme Flowable Composite, and/or, 3) Bulk-fill Composite	Bulk-fill Composite This is a split-mouth design with each subject receiving one or two replicates of each of three restorative dental-filling materials: 1) Supreme Universal Composite, 2) Supreme Flowable Composite, and/or, 3) Bulk-fill Composite
Overall Study STARTED	53 56	53 56	53 56
Overall Study COMPLETED	35 37	35 37	35 37
Overall Study NOT COMPLETED	18 19	18 19	18 19

Reasons for withdrawal

Measure	Universal Composite This is a split-mouth design with each subject receiving one or two replicates of each of three restorative dental-filling materials: 1) Supreme Universal Composite, 2) Supreme Flowable Composite, and/or, 3) Bulk-fill Composite	Flowable Composite This is a split-mouth design with each subject receiving one or two replicates of each of three restorative dental-filling materials: 1) Supreme Universal Composite, 2) Supreme Flowable Composite, and/or, 3) Bulk-fill Composite	Bulk-fill Composite This is a split-mouth design with each subject receiving one or two replicates of each of three restorative dental-filling materials: 1) Supreme Universal Composite, 2) Supreme Flowable Composite, and/or, 3) Bulk-fill Composite
Overall Study Lost to Follow-up	13	13	13
Overall Study Withdrawal by Subject	2	2	2
Overall Study Protocol Violation	1	1	1
Overall Study Exclusion Criteria -change in oral status	1	1	1
Overall Study Death	1	1	1

Baseline Characteristics

Clinical Performance of Incremental and Bulk Fill Composites in Class II Restorations

Baseline characteristics by cohort

Measure	Universal Composite, Flowable Composite, Bulk Fill Flowable Composite n=56 Teeth Split-mouth design where each enrolled subject received one or two replicates of three restorative materials: 1) Supreme Universal Restorative, 2) Supreme Flowable Restorative, and/or, 3) Bulk Fill Flowable Restorative
Age, Categorical <=18 years	0 Participants n=53 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=53 Participants
Age, Categorical >=65 years	9 Participants n=53 Participants
Sex: Female, Male Female	13 Participants n=53 Participants
Sex: Female, Male Male	40 Participants n=53 Participants
Region of Enrollment United States	53 participants n=53 Participants

PRIMARY outcome

Timeframe: 36 Months

Percentage of restorations that survived (percent clinically acceptable per FDI criteria) over 36 months.

Outcome measures

Measure	Universal Composite n=53 Teeth Supreme Universal Restorative	Flowable Composite n=54 Teeth Supreme Flowable Restorative	Bulk Fill Flowable Composite n=52 Teeth Bulk Fill Flowable Restorative
Percent Acceptable Restorations	94.6 percentage of restorations survived	96.4 percentage of restorations survived	92.9 percentage of restorations survived

SECONDARY outcome

Timeframe: 36 Month

Population: This population incudes all subjects that completed their three year visit.

1. Luster comparable to enamel

2. Slightly dull, not noticeable from speaking distance.

3. Surface is dull but still acceptable if the surface of the restoration is covered with a film of saliva.

4. Surface is rough and not masked by salivary film. Major re-finishing or veneering is necessary and possible.

5. Surface is unacceptably rough which makes it ugly and/or it retains noticeable biofilm (plaque). Improvement by finishing or veneering is not feasible.

Outcome measures

Measure	Universal Composite n=35 Teeth Supreme Universal Restorative	Flowable Composite n=34 Teeth Supreme Flowable Restorative	Bulk Fill Flowable Composite n=34 Teeth Bulk Fill Flowable Restorative
Surface Luster	1.50 units on a scale Standard Deviation 0.58	1.39 units on a scale Standard Deviation 0.57	1.41 units on a scale Standard Deviation 0.50

SECONDARY outcome

Timeframe: 36 Month

Population: This population incudes all subjects that completed their three year visit.

1. No surface staining.

2. Minor surface staining (under dry conditions) is present but is evenly spread over all the teeth. It does not affect the aesthetic properties because it is generalized and acceptable.

3. Moderate surface staining not noticeable from a speaking distance.

4. Surface staining is present on the restoration but not the tooth and is clearly recognizable from a speaking distance. The aesthetic properties of the dentition are affected. Restoration requires major correction and layering of new material.

5. Surface staining is totally unacceptable/unsightly and the restoration needs to be replaced.

Outcome measures

Measure	Universal Composite n=35 Teeth Supreme Universal Restorative	Flowable Composite n=34 Teeth Supreme Flowable Restorative	Bulk Fill Flowable Composite n=34 Teeth Bulk Fill Flowable Restorative
Surface Staining	1.21 units on a scale Standard Deviation 0.50	1.25 units on a scale Standard Deviation 0.44	1.19 units on a scale Standard Deviation 0.40

SECONDARY outcome

Timeframe: 36 Month

Population: This population incudes all subjects that completed their three year visit.

1. Colour and translucency of the restoration have a clinically excellent match with the surrounding enamel and adjacent teeth. There is no difference in shade, brightness or translucency between restoration and tooth.

2. Colour match is clinically acceptable but minor deviations in shade between tooth and restoration are apparent.

3. Colour match is satisfactory; there is a clear deviation in colour match that does not affect aesthetics.

4. Colour match is satisfactory; there is a clear deviation in colour match that does not affect aesthetics.

5. Colour match and/or translucency are clinically unsatisfactory. The restoration displays an unacceptable alteration in colour and/or translucency. Restoration needs replacement.

Outcome measures

Measure	Universal Composite n=35 Teeth Supreme Universal Restorative	Flowable Composite n=34 Teeth Supreme Flowable Restorative	Bulk Fill Flowable Composite n=34 Teeth Bulk Fill Flowable Restorative
Color Match	1.36 units on a scale Standard Deviation 0.49	1.32 units on a scale Standard Deviation 0.48	1.67 units on a scale Standard Deviation 0.73

SECONDARY outcome

Timeframe: 36 Month

Population: This population incudes all subjects that completed their three year visit.

1. No fractures / cracks.

2. Small hairline crack.

3. Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact.

4. Material chip fractures which damage marginal quality or approximal contacts.

5. Bulk fractures with partial loss (less than half of the restoration).

Outcome measures

Measure	Universal Composite n=35 Teeth Supreme Universal Restorative	Flowable Composite n=34 Teeth Supreme Flowable Restorative	Bulk Fill Flowable Composite n=34 Teeth Bulk Fill Flowable Restorative
Fracture of Material and Retention	1.21 units on a scale Standard Deviation 0.79	1.07 units on a scale Standard Deviation 0.38	1.04 units on a scale Standard Deviation 0.19

SECONDARY outcome

Timeframe: 36 Month

Population: This population incudes all subjects that completed their three year visit.

1. Physiological wear equivalent to enamel.

2. Normal wear only slightly different from that of enamel.

3. Different wear rate than enamel but within the biological variation.

4. Wear considerably exceeds normal enamel wear; or occlusal contact points are lost.

5. Wear considerably exceeds normal enamel wear; or occlusal contact points are lost.

Outcome measures

Measure	Universal Composite n=35 Participants Supreme Universal Restorative	Flowable Composite n=34 Participants Supreme Flowable Restorative	Bulk Fill Flowable Composite n=34 Participants Bulk Fill Flowable Restorative
Occlusal Wear - Qualitative	1.14 units on a scale Standard Deviation 0.36	1.07 units on a scale Standard Deviation 0.26	1.11 units on a scale Standard Deviation 0.32

SECONDARY outcome

Timeframe: 36 Month

Population: This population incudes all subjects that completed their three year visit.

1. Complete integrity.

2. Small marginal enamel fracture (<150 µm) / Hairline crack in enamel (<150 µm)

3. Marginal enamel defect <250µm / Crack <250µm / Enamel chipping

4. Multiple cracks / Major marginal enamel defects; gap > 250 µm or dentine or base exposed

5. Cusp or tooth fracture

Outcome measures

Measure	Universal Composite n=35 Teeth Supreme Universal Restorative	Flowable Composite n=34 Teeth Supreme Flowable Restorative	Bulk Fill Flowable Composite n=34 Teeth Bulk Fill Flowable Restorative
Tooth Integrity	1.00 units on a scale Standard Deviation 0	1.00 units on a scale Standard Deviation 0	1.00 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 36 Months

Population: This population incudes all subjects that completed their three year visit.

1. No secondary or primary caries

2. Small and localized: Demineralization / Erosion / Abfraction.

3. Larger areas of: Demineralisation / Erosion / Abrasion / abfraction, dentine not exposed. Only preventive measures necessary

4. Caries with cavitation and suspected undermining caries / Erosion in dentine / Abrasion, abfraction in dentine. Localized and accessible can be repaired.

5. Deep caries or exposed dentine that is not accessible for repair of restoration

Outcome measures

Measure	Universal Composite n=35 Teeth Supreme Universal Restorative	Flowable Composite n=34 Teeth Supreme Flowable Restorative	Bulk Fill Flowable Composite n=34 Teeth Bulk Fill Flowable Restorative
Recurrence of Caries, Erosion, Abfraction	1.15 units on a scale Standard Deviation 0.60	1.11 units on a scale Standard Deviation 0.57	1.04 units on a scale Standard Deviation 0.19

SECONDARY outcome

Timeframe: 36 Months

Population: This population incudes all subjects that completed their three year visit.

1. No clinically detectable gap.

2. Marginal integrity deviates from ideal but could be upgraded to ideal by polishing.

3. Leakage/discoloration is present but limited to border area of margins. Generalized marginal gap >150 µm but <250 µm, easily perceptible on probing but cannot be modified without minor damage to tooth or surrounding tissue, and is not considered to result in long-term negative consequences for tooth or surrounding tissue if left untreated. Presence of several small marginal fractures that are unlikely to cause long-term effects.

4. Localized gap larger than 250 µm, may result in exposure of dentine or base. Repair necessary for prophylactic reasons.

5. Generalized gap larger than 250 µm or restoration is loose but in situ, replacement necessary or large fractures at margins and loss of material is too extensive to be repaired.

Outcome measures

Measure	Universal Composite n=35 Teeth Supreme Universal Restorative	Flowable Composite n=34 Teeth Supreme Flowable Restorative	Bulk Fill Flowable Composite n=34 Teeth Bulk Fill Flowable Restorative
Margin Adaptation	1.41 units on a scale Standard Deviation 0.57	1.21 units on a scale Standard Deviation 0.42	1.33 units on a scale Standard Deviation 0.55

SECONDARY outcome

Timeframe: 36 Months

Population: This population incudes all subjects that completed their three year visit.

1. No marginal staining

2. Minor marginal staining, easily removable.

3. Moderate marginal staining, not aesthetically unacceptable.

4. Pronounced (mainly localized) marginal staining and not removable by polishing; major intervention necessary for improvement. of aesthetics

5. Deep marginal staining (generalized and/or profound), not accessible for intervention.

Outcome measures

Measure	Universal Composite n=35 Teeth Supreme Universal Restorative	Flowable Composite n=34 Teeth Supreme Flowable Restorative	Bulk Fill Flowable Composite n=34 Teeth Bulk Fill Flowable Restorative
Marginal Staining	1.33 units on a scale Standard Deviation 0.59	1.29 units on a scale Standard Deviation 0.53	1.26 units on a scale Standard Deviation 0.59

SECONDARY outcome

Timeframe: 36 Months

Population: This population incudes all subjects that completed their three year visit.

1. Contact is physiological (dental floss can only be inserted into the interdental space under pressure).

2. Contact is slightly too strong but acceptable. Floss or 25 µm metal blade can only be passed through contact with force/pressure.

3. Contact is weak, a 50 µm metal blade can pass through contact area but not a 100 µm blade, or floss passes very easily with only a slight snap effect. There is no indication for removing/repairing restoration and there is no damage to tooth, gingiva or other periodontal structures. There is no cervical caries, inflammation of the gingival papilla through food impaction, or pocket formation.

4. Contact is weak and a 100 µm metal blade can easily pass through. In addition there are signs of damage to tooth (i.e. cervical caries,). Repair is necessary.

5. Contact is weak allowing damage due to food impaction and demonstrating pain/gingivitis requires immediate intervention. Repair is not feasible and replacement is necessary.

Outcome measures

Measure	Universal Composite n=35 Teeth Supreme Universal Restorative	Flowable Composite n=34 Teeth Supreme Flowable Restorative	Bulk Fill Flowable Composite n=34 Teeth Bulk Fill Flowable Restorative
Proximal Contact Point	1.17 units on a scale Standard Deviation 0.58	1.17 units on a scale Standard Deviation 0.58	1.10 units on a scale Standard Deviation 0.45

SECONDARY outcome

Timeframe: 36 Months

Population: This population incudes all subjects that completed their three year visit.

1. Entirely satisfied with aesthetics and function

2. Satisfied with aesthetics and function

3. Minor criticism but no adverse clinical effects.

4. Desire for improvement (aesthetics / function); Reshaping of anatomic form or refurbishing is possible.

5. Completely dissatisfied and / or adverse effects, incl. pain

Outcome measures

Measure	Universal Composite n=35 Teeth Supreme Universal Restorative	Flowable Composite n=34 Teeth Supreme Flowable Restorative	Bulk Fill Flowable Composite n=34 Teeth Bulk Fill Flowable Restorative
Patient's View	1.0 units on a scale Standard Deviation 0.00	1.0 units on a scale Standard Deviation 0.00	1.0 units on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: 36 Months

Population: This population incudes all subjects that completed their three year visit.

1. No postoperative hypersensitivity. Normal pulp vitality response.

2. Postoperative hypersensitivity of short duration (less than one week) and no longer present at the baseline assessment. Pulp vitality response normal at baseline assessment (one week after placement).

3. Intense postoperative hypersensitivity of duration greater than one week but less than six-months.

4. Persistent postoperative hypersensitivity. Response to cold stimulus is markedly premature/strong and major intervention is necessary; or there is extremely delayed/weak and unclear or negative sensitivity. Sensitivity level is significantly different from the situation prior to treatment.

5. Negative sensitivity recorded at recall visit despite positive pulp response at baseline, or severe pain is noted. Removal of restoration and immediate root canal treatment is required or the tooth must be extracted.

Outcome measures

Measure	Universal Composite n=35 Teeth Supreme Universal Restorative	Flowable Composite n=34 Teeth Supreme Flowable Restorative	Bulk Fill Flowable Composite n=34 Teeth Bulk Fill Flowable Restorative
Post-op Sensitivity	1.04 units on a scale Standard Deviation 0.19	1.04 units on a scale Standard Deviation 0.09	1.07 units on a scale Standard Deviation 0.27

Adverse Events

Universal Composite

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Flowable Composite

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Bulk Fill Flowable Composite

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Measure	Universal Composite n=53 participants at risk Supreme Universal Restorative	Flowable Composite n=53 participants at risk Supreme Flowable Restorative	Bulk Fill Flowable Composite n=53 participants at risk Bulk Fill Flowable Restorative
General disorders death	1.9% 1/53 • Baseline through 36 months This was a split person design where each Subject received all three treatments. Only one Subject died, unrelated to study treatment. This death is reported for each of the three arms and so the sum total column indicates three deaths but it is actually only one.	1.9% 1/53 • Baseline through 36 months This was a split person design where each Subject received all three treatments. Only one Subject died, unrelated to study treatment. This death is reported for each of the three arms and so the sum total column indicates three deaths but it is actually only one.	1.9% 1/53 • Baseline through 36 months This was a split person design where each Subject received all three treatments. Only one Subject died, unrelated to study treatment. This death is reported for each of the three arms and so the sum total column indicates three deaths but it is actually only one.

Other adverse events

Measure	Universal Composite n=53 participants at risk Supreme Universal Restorative	Flowable Composite n=53 participants at risk Supreme Flowable Restorative	Bulk Fill Flowable Composite n=53 participants at risk Bulk Fill Flowable Restorative
General disorders Loss of retention	1.9% 1/53 • Number of events 1 • Baseline through 36 months This was a split person design where each Subject received all three treatments. Only one Subject died, unrelated to study treatment. This death is reported for each of the three arms and so the sum total column indicates three deaths but it is actually only one.	0.00% 0/53 • Baseline through 36 months This was a split person design where each Subject received all three treatments. Only one Subject died, unrelated to study treatment. This death is reported for each of the three arms and so the sum total column indicates three deaths but it is actually only one.	0.00% 0/53 • Baseline through 36 months This was a split person design where each Subject received all three treatments. Only one Subject died, unrelated to study treatment. This death is reported for each of the three arms and so the sum total column indicates three deaths but it is actually only one.
General disorders Restoration fracture	3.8% 2/53 • Number of events 2 • Baseline through 36 months This was a split person design where each Subject received all three treatments. Only one Subject died, unrelated to study treatment. This death is reported for each of the three arms and so the sum total column indicates three deaths but it is actually only one.	3.8% 2/53 • Number of events 2 • Baseline through 36 months This was a split person design where each Subject received all three treatments. Only one Subject died, unrelated to study treatment. This death is reported for each of the three arms and so the sum total column indicates three deaths but it is actually only one.	3.8% 2/53 • Number of events 2 • Baseline through 36 months This was a split person design where each Subject received all three treatments. Only one Subject died, unrelated to study treatment. This death is reported for each of the three arms and so the sum total column indicates three deaths but it is actually only one.
General disorders Pulpitis	0.00% 0/53 • Baseline through 36 months This was a split person design where each Subject received all three treatments. Only one Subject died, unrelated to study treatment. This death is reported for each of the three arms and so the sum total column indicates three deaths but it is actually only one.	0.00% 0/53 • Baseline through 36 months This was a split person design where each Subject received all three treatments. Only one Subject died, unrelated to study treatment. This death is reported for each of the three arms and so the sum total column indicates three deaths but it is actually only one.	3.8% 2/53 • Number of events 2 • Baseline through 36 months This was a split person design where each Subject received all three treatments. Only one Subject died, unrelated to study treatment. This death is reported for each of the three arms and so the sum total column indicates three deaths but it is actually only one.

Additional Information

Nathaniel Lawson DMD PhD

UAB School of Dentistry

Phone: 205-975-8302

Email: nlawson@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place