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

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ClinicalTrials.gov Identifier: NCT03032705
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : July 25, 2017
Sponsor:
Collaborator:
Kavo Kerr Group
Information provided by (Responsible Party):
Tufts University School of Dental Medicine

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 Not Applicable

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
  • Aproximal anatomical form - contact point
  • Radiographic 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 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 : June 19, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

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.




Primary Outcome Measures :
  1. Change in Esthetic Properties [ Time Frame: 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

  2. Change in Functional Properties [ Time Frame: 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. Aproximal anatomical form - contact point
    4. Radiographic examination (when applicable)
    5. Patient's view

  3. Change in Biological Properties [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032705


Contacts
Contact: Amanda Gozzi, MS 617- dentalresearchadministration@tufts.edu

Locations
United States, Massachusetts
Tufts University School of Dental Medicine Recruiting
Boston, Massachusetts, United States, 02111
Contact: Amanda Gozzi       dentalresearchadministration@tufts.edu   
Sponsors and Collaborators
Tufts University School of Dental Medicine
Kavo Kerr Group
Investigators
Principal Investigator: Gerard Kugel, DMD, MS, PhD TUSDM

Responsible Party: Tufts University School of Dental Medicine
ClinicalTrials.gov Identifier: NCT03032705     History of Changes
Other Study ID Numbers: 12311
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Tufts University School of Dental Medicine:
Restorations
Composite

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants