Dental Caries
Conditions
Keywords
Restorations, Composite
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.
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
Interventions
DEVICESonicFill™ 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.
DEVICEFiltek™ 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.
Sponsors
KaVo Kerr
Tufts University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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: 1. Surface luster 2. Staining - surface 3. Staining - margin 4. Color match and translucency 5. Esthetic anatomical form Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable |
| 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: 1. Fracture of material and retention 2. Marginal adaptation 3. Approximate anatomical form - contact point 4. Radio-graphic examination (when applicable) 5. Patient's view Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable |
| 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: 1. Postoperative (hyper-)sensitivity and tooth vitality 2. Recurrence of caries, erosion, abfraction 3. Tooth integrity (enamel cracks, tooth fractures) 4. Adjacent mucosa Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| SonicFill™ 2 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. | 45 |
| SonicFill™ 2 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. | 45 |
| Filtek™ Supreme 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. | 45 |
| Filtek™ Supreme 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. | 45 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | did not quality | 6 | 6 |
| Overall Study | Lost to Follow-up | 16 | 17 |
Baseline characteristics
| Characteristic | SonicFill™ 2 | Filtek™ Supreme | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 43 Participants | 86 Participants |
| Age, Continuous | 44.13 years STANDARD_DEVIATION 1.92 | 44.13 years STANDARD_DEVIATION 1.92 | 44.13 years STANDARD_DEVIATION 1.92 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 9 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 33 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 8 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 12 Participants | 24 Participants |
| Race (NIH/OMB) White | 21 Participants | 21 Participants | 42 Participants |
| Region of Enrollment United States | 45 participants | 45 participants | 45 participants |
| Sex: Female, Male Female | 26 Participants | 26 Participants | 52 Participants |
| Sex: Female, Male Male | 19 Participants | 19 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 51 |
| other Total, other adverse events | 14 / 45 | 15 / 45 |
| serious Total, serious adverse events | 0 / 51 | 0 / 51 |
Outcome results
Primary
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
The following properties will be evaluated using the Hickel Grading Criteria: 1. Postoperative (hyper-)sensitivity and tooth vitality 2. Recurrence of caries, erosion, abfraction 3. Tooth integrity (enamel cracks, tooth fractures) 4. 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
Population: 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 | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| SonicFill™ 2 | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 1 | 27 Teeth |
| SonicFill™ 2 | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 2 | 1 Teeth |
| SonicFill™ 2 | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 3 | 0 Teeth |
| SonicFill™ 2 | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 4 | 0 Teeth |
| SonicFill™ 2 | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 5 | 0 Teeth |
| SonicFill™ 2 | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 1 | 27 Teeth |
| SonicFill™ 2 | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 2 | 1 Teeth |
| SonicFill™ 2 | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 3 | 0 Teeth |
| SonicFill™ 2 | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 4 | 0 Teeth |
| SonicFill™ 2 | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 5 | 0 Teeth |
| SonicFill™ 2 | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Tooth Integrity at end of study : Number of teeth rated 1 | 28 Teeth |
| SonicFill™ 2 | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Tooth Integrity at end of study : Number of teeth rated 2 | 0 Teeth |
| SonicFill™ 2 | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Tooth Integrity at end of study : Number of teeth rated 3 | 0 Teeth |
| SonicFill™ 2 | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Tooth Integrity at end of study : Number of teeth rated 4 | 0 Teeth |
| SonicFill™ 2 | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Tooth Integrity at end of study : Number of teeth rated 5 | 0 Teeth |
| SonicFill™ 2 | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Adjacent Mucosa at end of study : Number of teeth rated 1 | 27 Teeth |
| SonicFill™ 2 | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Adjacent Mucosa at end of study : Number of teeth rated 2 | 1 Teeth |
| SonicFill™ 2 | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Adjacent Mucosa at end of study : Number of teeth rated 3 | 0 Teeth |
| SonicFill™ 2 | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Adjacent Mucosa at end of study : Number of teeth rated 4 | 0 Teeth |
| SonicFill™ 2 | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Adjacent Mucosa at end of study : Number of teeth rated 5 | 0 Teeth |
| Filtek™ Supreme | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Adjacent Mucosa at end of study : Number of teeth rated 3 | 0 Teeth |
| Filtek™ Supreme | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 1 | 27 Teeth |
| Filtek™ Supreme | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Tooth Integrity at end of study : Number of teeth rated 1 | 27 Teeth |
| Filtek™ Supreme | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 2 | 0 Teeth |
| Filtek™ Supreme | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Adjacent Mucosa at end of study : Number of teeth rated 1 | 26 Teeth |
| Filtek™ Supreme | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 3 | 0 Teeth |
| Filtek™ Supreme | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Tooth Integrity at end of study : Number of teeth rated 2 | 0 Teeth |
| Filtek™ Supreme | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 4 | 0 Teeth |
| Filtek™ Supreme | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Adjacent Mucosa at end of study : Number of teeth rated 5 | 0 Teeth |
| Filtek™ Supreme | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 5 | 0 Teeth |
| Filtek™ Supreme | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Tooth Integrity at end of study : Number of teeth rated 3 | 0 Teeth |
| Filtek™ Supreme | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 1 | 27 Teeth |
| Filtek™ Supreme | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Adjacent Mucosa at end of study : Number of teeth rated 2 | 1 Teeth |
| Filtek™ Supreme | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 2 | 0 Teeth |
| Filtek™ Supreme | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Tooth Integrity at end of study : Number of teeth rated 4 | 0 Teeth |
| Filtek™ Supreme | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 3 | 0 Teeth |
| Filtek™ Supreme | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Adjacent Mucosa at end of study : Number of teeth rated 4 | 0 Teeth |
| Filtek™ Supreme | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 4 | 0 Teeth |
| Filtek™ Supreme | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Tooth Integrity at end of study : Number of teeth rated 5 | 0 Teeth |
| Filtek™ Supreme | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 5 | 0 Teeth |
Primary
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
The following properties will be evaluated using the Hickel Grading Criteria: 1. Surface luster 2. Staining - surface 3. Staining - margin 4. Color match and translucency 5. 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
Population: 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 | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Surface Luster at end of study : Number of teeth rated 3 | 0 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Marginal Staining at end of study : Number of teeth rated 4 | 0 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Surface Staining at end of study : Number of teeth rated 3 | 1 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Marginal Staining at end of study : Number of teeth rated 5 | 0 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Surface Luster at end of study : Number of teeth rated 5 | 0 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Color Match and Translucency at end of study : Number of teeth rated 1 | 21 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Surface Staining at end of study : Number of teeth rated 4 | 0 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Color Match and Translucency at end of study : Number of teeth rated 2 | 7 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Surface Luster at end of study : Number of teeth rated 2 | 2 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Color Match and Translucency at end of study : Number of teeth rated 3 | 0 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Surface Staining at end of study : Number of teeth rated 5 | 0 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Color Match and Translucency at end of study : Number of teeth rated 4 | 0 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Surface Staining at end of study : Number of teeth rated 1 | 26 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Color Match and Translucency at end of study : Number of teeth rated 5 | 0 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Marginal Staining at end of study : Number of teeth rated 1 | 25 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Esthetic Anatomical Form at end of study : Number of teeth rated 1 | 27 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Surface Luster at end of study : Number of teeth rated 4 | 1 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Esthetic Anatomical Form at end of study : Number of teeth rated 2 | 1 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Marginal Staining at end of study : Number of teeth rated 2 | 2 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Esthetic Anatomical Form at end of study : Number of teeth rated 3 | 0 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Surface Staining at end of study : Number of teeth rated 2 | 1 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Esthetic Anatomical Form at end of study : Number of teeth rated 4 | 0 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Marginal Staining at end of study : Number of teeth rated 3 | 1 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Esthetic Anatomical Form at end of study : Number of teeth rated 5 | 0 Teeth |
| SonicFill™ 2 | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Surface Luster at end of study : Number of teeth rated 1 | 25 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Esthetic Anatomical Form at end of study : Number of teeth rated 5 | 0 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Surface Luster at end of study : Number of teeth rated 1 | 25 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Surface Luster at end of study : Number of teeth rated 2 | 2 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Surface Luster at end of study : Number of teeth rated 3 | 0 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Surface Luster at end of study : Number of teeth rated 4 | 0 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Surface Luster at end of study : Number of teeth rated 5 | 0 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Surface Staining at end of study : Number of teeth rated 1 | 22 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Surface Staining at end of study : Number of teeth rated 2 | 3 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Surface Staining at end of study : Number of teeth rated 3 | 2 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Surface Staining at end of study : Number of teeth rated 4 | 0 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Surface Staining at end of study : Number of teeth rated 5 | 0 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Marginal Staining at end of study : Number of teeth rated 1 | 24 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Marginal Staining at end of study : Number of teeth rated 2 | 3 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Marginal Staining at end of study : Number of teeth rated 3 | 0 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Marginal Staining at end of study : Number of teeth rated 4 | 0 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Marginal Staining at end of study : Number of teeth rated 5 | 0 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Color Match and Translucency at end of study : Number of teeth rated 1 | 17 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Color Match and Translucency at end of study : Number of teeth rated 2 | 9 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Color Match and Translucency at end of study : Number of teeth rated 3 | 1 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Color Match and Translucency at end of study : Number of teeth rated 4 | 0 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Color Match and Translucency at end of study : Number of teeth rated 5 | 0 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Esthetic Anatomical Form at end of study : Number of teeth rated 1 | 25 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Esthetic Anatomical Form at end of study : Number of teeth rated 2 | 2 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Esthetic Anatomical Form at end of study : Number of teeth rated 3 | 0 Teeth |
| Filtek™ Supreme | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | Esthetic Anatomical Form at end of study : Number of teeth rated 4 | 0 Teeth |
Primary
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
The following properties will be evaluated using the Hickel Grading Criteria: 1. Fracture of material and retention 2. Marginal adaptation 3. Approximate anatomical form - contact point 4. Radio-graphic examination (when applicable) 5. 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
Population: 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 | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| SonicFill™ 2 | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Fracture of Material and Retention at end of study : Number of teeth rated 1 | 27 Teeth |
| SonicFill™ 2 | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Fracture of Material and Retention at end of study : Number of teeth rated 2 | 0 Teeth |
| SonicFill™ 2 | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Fracture of Material and Retention at end of study : Number of teeth rated 3 | 1 Teeth |
| SonicFill™ 2 | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Fracture of Material and Retention at end of study : Number of teeth rated 4 | 0 Teeth |
| SonicFill™ 2 | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Fracture of Material and Retention at end of study : Number of teeth rated 5 | 0 Teeth |
| SonicFill™ 2 | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Marginal Adaptation at end of study : Number of teeth rated 1 | 23 Teeth |
| SonicFill™ 2 | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Marginal Adaptation at end of study : Number of teeth rated 2 | 5 Teeth |
| SonicFill™ 2 | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Marginal Adaptation at end of study : Number of teeth rated 3 | 0 Teeth |
| SonicFill™ 2 | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Marginal Adaptation at end of study : Number of teeth rated 4 | 0 Teeth |
| SonicFill™ 2 | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Marginal Adaptation at end of study : Number of teeth rated 5 | 0 Teeth |
| SonicFill™ 2 | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Radiographic Examination at end of study : Number of teeth rated 1 | 26 Teeth |
| SonicFill™ 2 | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Radiographic Examination at end of study : Number of teeth rated 2 | 0 Teeth |
| SonicFill™ 2 | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Radiographic Examination at end of study : Number of teeth rated 3 | 2 Teeth |
| SonicFill™ 2 | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Radiographic Examination at end of study : Number of teeth rated 4 | 0 Teeth |
| SonicFill™ 2 | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Radiographic Examination at end of study : Number of teeth rated 5 | 0 Teeth |
| SonicFill™ 2 | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Patient's View at end of study : Number of teeth rated 1 | 27 Teeth |
| SonicFill™ 2 | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Patient's View at end of study : Number of teeth rated 2 | 0 Teeth |
| SonicFill™ 2 | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Patient's View at end of study : Number of teeth rated 3 | 1 Teeth |
| SonicFill™ 2 | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Patient's View at end of study : Number of teeth rated 4 | 0 Teeth |
| SonicFill™ 2 | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Patient's View at end of study : Number of teeth rated 5 | 0 Teeth |
| Filtek™ Supreme | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Patient's View at end of study : Number of teeth rated 3 | 0 Teeth |
| Filtek™ Supreme | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Fracture of Material and Retention at end of study : Number of teeth rated 1 | 26 Teeth |
| Filtek™ Supreme | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Radiographic Examination at end of study : Number of teeth rated 1 | 26 Teeth |
| Filtek™ Supreme | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Fracture of Material and Retention at end of study : Number of teeth rated 2 | 1 Teeth |
| Filtek™ Supreme | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Patient's View at end of study : Number of teeth rated 1 | 27 Teeth |
| Filtek™ Supreme | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Fracture of Material and Retention at end of study : Number of teeth rated 3 | 0 Teeth |
| Filtek™ Supreme | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Radiographic Examination at end of study : Number of teeth rated 2 | 1 Teeth |
| Filtek™ Supreme | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Fracture of Material and Retention at end of study : Number of teeth rated 4 | 0 Teeth |
| Filtek™ Supreme | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Patient's View at end of study : Number of teeth rated 5 | 0 Teeth |
| Filtek™ Supreme | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Fracture of Material and Retention at end of study : Number of teeth rated 5 | 0 Teeth |
| Filtek™ Supreme | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Radiographic Examination at end of study : Number of teeth rated 3 | 0 Teeth |
| Filtek™ Supreme | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Marginal Adaptation at end of study : Number of teeth rated 1 | 25 Teeth |
| Filtek™ Supreme | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Patient's View at end of study : Number of teeth rated 2 | 0 Teeth |
| Filtek™ Supreme | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Marginal Adaptation at end of study : Number of teeth rated 2 | 2 Teeth |
| Filtek™ Supreme | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Radiographic Examination at end of study : Number of teeth rated 4 | 0 Teeth |
| Filtek™ Supreme | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Marginal Adaptation at end of study : Number of teeth rated 3 | 0 Teeth |
| Filtek™ Supreme | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Patient's View at end of study : Number of teeth rated 4 | 0 Teeth |
| Filtek™ Supreme | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Marginal Adaptation at end of study : Number of teeth rated 4 | 0 Teeth |
| Filtek™ Supreme | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Radiographic Examination at end of study : Number of teeth rated 5 | 0 Teeth |
| Filtek™ Supreme | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | Marginal Adaptation at end of study : Number of teeth rated 5 | 0 Teeth |