Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative

• Sponsor: Tufts University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03032705
• Collaborator: Kavo Kerr Group (Other)

Study Details

Study Description

Brief Summary

The purpose of this study is to compare esthetic, functional and biological properties of two restoration materials used to fill cavities. One material is called "Filtek™ Supreme" which is a traditional tooth colored resin composite that is placed in the cavity in layers and hardened with UV light. The second material is called "SonicFill™ 2," which is a bulk fill composite that uses an ultrasonic hand piece to change the material from a solid into a liquid in order to place it into the cavity. This material can be placed in the cavity in 1 layer, and is hardened using UV light. Both materials have been FDA approved as non-significant risk devices for filling cavities.

In each subject, one tooth with a cavity will be randomly selected to receive one filling material, and a second tooth with a cavity will be randomly selected to receive the second material. The fillings will be observed over a two year period to determine clinical acceptability.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Device: SonicFill™ 2; Device: Filtek™ Supreme	N/A

Detailed Description

This study is a randomized, split-mouth, controlled, examiner-blinded clinical evaluation of Class II restorations using a new bulk-fill composite (SonicFill™ 2) and comparing it to Filtek™ Supreme resin composite placed in the traditional incremental technique.

The primary objective of this study is to evaluate the clinical performance of a sonic-activated, bulk fill composite, SonicFill™ 2, by comparing it to Filtek™ Supreme in the following categories:

Esthetic Properties

• Surface luster

• Staining - surface

• Staining - margin

• Color match and translucency

• Esthetic anatomical form

Functional Properties

• Fracture of material and retention

• Marginal adaptation

• Approximate anatomical form - contact point

• Radio-graphic examination (when applicable)

• Patient's view

Biological Properties

• Postoperative (hyper-)sensitivity and tooth vitality

• Recurrence of caries, erosion, abfraction

• Tooth integrity (enamel cracks, tooth fractures)

• Adjacent mucosa

The hypothesis to be tested is that the sonic-activated, bulk fill composite, SonicFill™ 2, will have comparable results to the traditional incremental technique composite, Filtek™ Supreme, in overall clinical acceptability and in all compared categories

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative
• Actual Study Start Date: Jun 19, 2017
• Actual Primary Completion Date: Feb 5, 2020
• Actual Study Completion Date: Feb 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SonicFill™ 2 Composite: SonicFill™ 2; Bonding Agent: Optibond XRT	Device: SonicFill™ 2; The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.
Active Comparator: Filtek™ Supreme Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive	Device: Filtek™ Supreme; The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.

Outcome Measures

Primary Outcome Measures

1. Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category [From Baseline up to 2 Years After Restoration Placement]

   The following properties will be evaluated using the Hickel Grading Criteria: Surface luster Staining - surface Staining - margin Color match and translucency Esthetic anatomical form Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable

2. Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category [From Baseline up to 2 Years After Restoration Placement]

   The following properties will be evaluated using the Hickel Grading Criteria: Fracture of material and retention Marginal adaptation Approximate anatomical form - contact point Radio-graphic examination (when applicable) Patient's view Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable

3. Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category [From Baseline up to 2 Years After Restoration Placement]

   The following properties will be evaluated using the Hickel Grading Criteria: Postoperative (hyper-)sensitivity and tooth vitality Recurrence of caries, erosion, abfraction Tooth integrity (enamel cracks, tooth fractures) Adjacent mucosa Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Is at least 18 years of age

• Is willing to provide voluntary written informed consent

• Is in good medical health and able to tolerate the dental procedures

• Has at least 1 pair of qualifying molars or premolars that require Class II restorations.

• Restorations must have a buccal to lingual/palatal width equal to or greater than 1/3 the distance from buccal to lingual/palatal cusp tips

• Study teeth must be in occlusal function and must also be in contact with the neighboring tooth on at least one surface

• Study teeth must be vital (i.e., free of clinical signs and symptoms of periapical pathology)

Exclusion Criteria:

• Is currently taking part in an evaluation of other dental restorative materials

• Has chronic periodontitis or rampant caries

• Teeth exhibiting clinical signs of periapical pathology

• Teeth with a history of self-reported preoperative pulpal problems

• Women who are pregnant (self-reported). It is standard of care to post-pone routine dental procedures and radiographed until after pregnancy.

• Women who are breast feeding.

• Known allergy to resin composites or local anesthetics.

• Abnormal oral soft tissue findings (e.g., open sores, lesions)

• An employee of the sponsor or members of their immediate family.

• Condition affecting salivary flow (e.g., salivary gland disorder, Sjögren's Syndrome)

• Any restorative treatment of the teeth involved in the study in the last 12 months.

• Are unwilling or unable to have dental radiographs or photographs taken of their dentition and soft tissues

• Any other condition which is the view of the investigator may affect the ability of a patient to complete the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tufts University School of Dental Medicine	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

• Tufts University
• Kavo Kerr Group

Investigators

• Principal Investigator: Gerard Kugel, DMD, MS, PhD, TUSDM

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 2, 2018
• Informed Consent Form - Sep 19, 2017

More Information

Publications

None provided.

• Responsible Party: Dr. Gerard Kugel, Professor, Tufts University
• ClinicalTrials.gov Identifier: NCT03032705
• Other Study ID Numbers: 12311
• First Posted: Jan 26, 2017
• Last Update Posted: Dec 13, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Dr. Gerard Kugel, Professor, Tufts University: Restorations; Composite
• Additional relevant MeSH terms: Dental Caries

Study Results

Participant Flow

Recruitment Details	Unit = Teeth. 51 participants were randomized in this study, and a total of 102 teeth were studied. Therefore 51 participants and 102 units.

Arm/Group Title	SonicFill™ 2	Filtek™ Supreme
Arm/Group Description	Composite: SonicFill™ 2; Bonding Agent: Optibond XRT SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.	Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.
Period Title: Overall Study
STARTED	51	51
Completion of Restorations (V2)	45	45
COMPLETED	29	28
NOT COMPLETED	22	23

Baseline Characteristics

Arm/Group Title	SonicFill™ 2	Filtek™ Supreme	Total
Arm/Group Description	Composite: SonicFill™ 2; Bonding Agent: Optibond XRT SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.	Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.	Total of all reporting groups
Overall Participants	45	45	45
Overall teeth	45	45	90
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	43 95.6%	43 95.6%	86 191.1%
>=65 years	2 4.4%	2 4.4%	4 8.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.13 (1.92)	44.13 (1.92)	44.13 (1.92)
Sex: Female, Male (Count of Participants)
Female	26 57.8%	26 57.8%	52 115.6%
Male	19 42.2%	19 42.2%	38 84.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	9 20%	9 20%	18 40%
Not Hispanic or Latino	33 73.3%	33 73.3%	66 146.7%
Unknown or Not Reported	3 6.7%	3 6.7%	6 13.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	4 8.9%	4 8.9%	8 17.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	8 17.8%	8 17.8%	16 35.6%
White	21 46.7%	21 46.7%	42 93.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	12 26.7%	12 26.7%	24 53.3%
Region of Enrollment (participants) [Number]
United States	45 100%	45 100%	45 100%

Outcome Measures

1. Primary Outcome

Title	Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Description	The following properties will be evaluated using the Hickel Grading Criteria: Surface luster Staining - surface Staining - margin Color match and translucency Esthetic anatomical form Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable
Time Frame	From Baseline up to 2 Years After Restoration Placement

Outcome Measure Data

Analysis Population Description

45 Participants, each with 2 "units" (teeth) sampled. Due to participant drop out and replaced restorations, end-of-study categories have fewer than 45 units analyzed. 29 participants completed Visit 5 of the study - 28 teeth with SonicFill™ 2 (1 restoration replaced) and 27 teeth with Filtek™ Supreme (2 restorations replaced).

Arm/Group Title	SonicFill™ 2	Filtek™ Supreme
Arm/Group Description	Composite: SonicFill™ 2; Bonding Agent: Optibond XRT SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.	Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.
Measure Participants	45	45
Measure Teeth	45	45
Surface Luster at end of study : Number of teeth rated 1	25	25
Surface Luster at end of study : Number of teeth rated 2	2	2
Surface Luster at end of study : Number of teeth rated 3	0	0
Surface Luster at end of study : Number of teeth rated 4	1	0
Surface Luster at end of study : Number of teeth rated 5	0	0
Surface Staining at end of study : Number of teeth rated 1	26	22
Surface Staining at end of study : Number of teeth rated 2	1	3
Surface Staining at end of study : Number of teeth rated 3	1	2
Surface Staining at end of study : Number of teeth rated 4	0	0
Surface Staining at end of study : Number of teeth rated 5	0	0
Marginal Staining at end of study : Number of teeth rated 1	25	24
Marginal Staining at end of study : Number of teeth rated 2	2	3
Marginal Staining at end of study : Number of teeth rated 3	1	0
Marginal Staining at end of study : Number of teeth rated 4	0	0
Marginal Staining at end of study : Number of teeth rated 5	0	0
Color Match and Translucency at end of study : Number of teeth rated 1	21	17
Color Match and Translucency at end of study : Number of teeth rated 2	7	9
Color Match and Translucency at end of study : Number of teeth rated 3	0	1
Color Match and Translucency at end of study : Number of teeth rated 4	0	0
Color Match and Translucency at end of study : Number of teeth rated 5	0	0
Esthetic Anatomical Form at end of study : Number of teeth rated 1	27	25
Esthetic Anatomical Form at end of study : Number of teeth rated 2	1	2
Esthetic Anatomical Form at end of study : Number of teeth rated 3	0	0
Esthetic Anatomical Form at end of study : Number of teeth rated 4	0	0
Esthetic Anatomical Form at end of study : Number of teeth rated 5	0	0

2. Primary Outcome

Title	Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Description	The following properties will be evaluated using the Hickel Grading Criteria: Fracture of material and retention Marginal adaptation Approximate anatomical form - contact point Radio-graphic examination (when applicable) Patient's view Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable
Time Frame	From Baseline up to 2 Years After Restoration Placement

Outcome Measure Data

Analysis Population Description

45 Participants, each with 2 "units" (teeth) sampled. Due to participant drop out and replaced restorations, end-of-study categories have fewer than 45 units analyzed. 29 participants completed Visit 5 of the study - 28 teeth with SonicFill™ 2 (1 restoration replaced) and 27 teeth with Filtek™ Supreme (2 restorations replaced).

Arm/Group Title	SonicFill™ 2	Filtek™ Supreme
Arm/Group Description	Composite: SonicFill™ 2; Bonding Agent: Optibond XRT SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.	Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.
Measure Participants	45	45
Measure Teeth	45	45
Fracture of Material and Retention at end of study : Number of teeth rated 1	27	26
Fracture of Material and Retention at end of study : Number of teeth rated 2	0	1
Fracture of Material and Retention at end of study : Number of teeth rated 3	1	0
Fracture of Material and Retention at end of study : Number of teeth rated 4	0	0
Fracture of Material and Retention at end of study : Number of teeth rated 5	0	0
Marginal Adaptation at end of study : Number of teeth rated 1	23	25
Marginal Adaptation at end of study : Number of teeth rated 2	5	2
Marginal Adaptation at end of study : Number of teeth rated 3	0	0
Marginal Adaptation at end of study : Number of teeth rated 4	0	0
Marginal Adaptation at end of study : Number of teeth rated 5	0	0
Radiographic Examination at end of study : Number of teeth rated 1	26	26
Radiographic Examination at end of study : Number of teeth rated 2	0	1
Radiographic Examination at end of study : Number of teeth rated 3	2	0
Radiographic Examination at end of study : Number of teeth rated 4	0	0
Radiographic Examination at end of study : Number of teeth rated 5	0	0
Patient's View at end of study : Number of teeth rated 1	27	27
Patient's View at end of study : Number of teeth rated 2	0	0
Patient's View at end of study : Number of teeth rated 3	1	0
Patient's View at end of study : Number of teeth rated 4	0	0
Patient's View at end of study : Number of teeth rated 5	0	0

3. Primary Outcome

Title	Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Description	The following properties will be evaluated using the Hickel Grading Criteria: Postoperative (hyper-)sensitivity and tooth vitality Recurrence of caries, erosion, abfraction Tooth integrity (enamel cracks, tooth fractures) Adjacent mucosa Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable
Time Frame	From Baseline up to 2 Years After Restoration Placement

Outcome Measure Data

Analysis Population Description

45 Participants, each with 2 "units" (teeth) sampled. Due to participant drop out and replaced restorations, end-of-study categories have fewer than 45 units analyzed. 29 participants completed Visit 5 of the study - 28 teeth with SonicFill™ 2 (1 restoration replaced) and 27 teeth with Filtek™ Supreme (2 restorations replaced).

Arm/Group Title	SonicFill™ 2	Filtek™ Supreme
Arm/Group Description	Composite: SonicFill™ 2; Bonding Agent: Optibond XRT SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.	Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.
Measure Participants	45	45
Measure Teeth	45	45
Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 1	27	27
Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 2	1	0
Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 3	0	0
Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 4	0	0
Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 5	0	0
Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 1	27	27
Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 2	1	0
Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 3	0	0
Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 4	0	0
Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 5	0	0
Tooth Integrity at end of study : Number of teeth rated 1	28	27
Tooth Integrity at end of study : Number of teeth rated 2	0	0
Tooth Integrity at end of study : Number of teeth rated 3	0	0
Tooth Integrity at end of study : Number of teeth rated 4	0	0
Tooth Integrity at end of study : Number of teeth rated 5	0	0
Adjacent Mucosa at end of study : Number of teeth rated 1	27	26
Adjacent Mucosa at end of study : Number of teeth rated 2	1	1
Adjacent Mucosa at end of study : Number of teeth rated 3	0	0
Adjacent Mucosa at end of study : Number of teeth rated 4	0	0
Adjacent Mucosa at end of study : Number of teeth rated 5	0	0

Adverse Events

Time Frame	Through study completion, an average of 24 months.
Adverse Event Reporting Description	Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.
Arm/Group Title	SonicFill™ 2		Filtek™ Supreme
Arm/Group Description	Composite: SonicFill™ 2; Bonding Agent: Optibond XRT SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.		Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.
All Cause Mortality
	SonicFill™ 2		Filtek™ Supreme
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/51 (0%)
Serious Adverse Events
	SonicFill™ 2		Filtek™ Supreme
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	SonicFill™ 2		Filtek™ Supreme
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/45 (31.1%)		15/45 (33.3%)
General disorders
Pulp exposure risk, healing of non- study site, Alterantion of study site due to non-study site tx	3/45 (6.7%)		4/45 (8.9%)
Injury, poisoning and procedural complications
Post operative sensitivity/Pain	6/45 (13.3%)		5/45 (11.1%)
Product Issues
Fracture of restorations	2/45 (4.4%)		3/45 (6.7%)
Skin and subcutaneous tissue disorders
Soft tissue irritation	3/45 (6.7%)		3/45 (6.7%)

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.