Clinical trial NCT03032705: Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative
Official title: Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Restorations
Composite
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: KaVo Kerr
First posted: 2017-01-26
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
timeFrame: From Baseline up to 2 Years After Restoration Placement
measure: Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
timeFrame: From Baseline up to 2 Years After Restoration Placement
measure: Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
timeFrame: From Baseline up to 2 Years After Restoration Placement
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: TUSDM
name: Gerard Kugel, DMD, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: