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Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth

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ClinicalTrials.gov Identifier: NCT02572570
Recruitment Status : Recruiting
First Posted : October 9, 2015
Last Update Posted : September 15, 2017
Sponsor:
Collaborator:
3M ESPE
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
Polymerization shrinkage remains one of the primary disadvantages of composite resin restorative materials (tooth-colored fillings). To minimize the effects of polymerization shrinkage in the restorative treatment, the 3M ESPE company has developed a composite resin called Filtek Bulk Fill Posterior Restorative. Its decreased polymerization shrinkage and properties allow the material to be inserted in one single increment, expediting treatment. This clinical trial is designed to evaluate the performance of the new bulk fill composite resin in Class II (two-surface posterior) fillings.

Condition or disease Intervention/treatment Phase
Dental Restoration Failure of Marginal Integrity Dental Caries Unrepairable Overhanging of Dental Restorative Materials Poor Aesthetics of Existing Restoration Secondary Dental Caries Associated With Failed or Defective Dental Restorations Fractured Dental Restorative Materials Without Loss of Materials Fracture of Dental Restorative Materials With Loss of Material Device: Filtek Bulk Fill Posterior Device: Filtek Supreme Ultra Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth
Study Start Date : December 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Experimental: Filtek Bulk Fill Posterior
Commercially available tooth-colored filling that will be used for direct restoration as per manufacturer's instructions.
Device: Filtek Bulk Fill Posterior
Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the materials listed (Filtek Bulk Fill Posterior). Procedures will be done using local anesthesia and following ordinary restorative techniques.
Other Name: Dental filling

Active Comparator: Filtek Supreme Ultra
Commercially available tooth-colored filling that will be used for direct restoration as per manufacturer's instructions.
Device: Filtek Supreme Ultra
Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the materials listed (Filtek Supreme Ultra). Procedures will be done using local anesthesia and following ordinary restorative techniques.
Other Name: Dental filling




Primary Outcome Measures :
  1. Percent success in Filtek Bulk Fill & Filtek Supreme Ultra composite resin restorations at Year 2 [ Time Frame: Baseline, Year 2 ]

    Cases will be considered successful if each of the 16 following World Dental Federation (FDI) criteria presents a individual score of 3 or less:

    A. Esthetic Properties

    • Surface lustre [Item 1]
    • Staining (a) surface (b) margin [Item 2]
    • Color match and translucency [Item 3]
    • Esthetic anatomical form [Item 4]

    B. Functional Properties

    • Fracture of material and retention (a) qualitatively (b) quantitatively [Item 5]
    • Marginal adaptation [Item 6]
    • Wear [Item 7]
    • Approximal anatomical form (a) contact point (b) contour [Item 8]
    • Radiographic examination [Item 9]
    • Patient's view [Item 10]

    C. Biological Properties

    • Postoperative (hyper-)sensitivity and tooth vitality [Item 11]
    • Recurrence of caries (CAR), erosion, abfraction [Item 12]
    • Tooth integrity (enamel cracks, tooth fractures) [Item 13]
    • Periodontal response (always compared to a reference tooth) [Item 14]
    • Adjacent mucosa [Item 15]
    • Oral and general Health [Item 16]


Secondary Outcome Measures :
  1. Percent success in Filtek Bulk Fill & Filtek Supreme Ultra composite resin restorations at 6 months [ Time Frame: Baseline, 6 Months ]

    Cases will be considered successful if each of the 16 following World Dental Federation (FDI) criteria presents a individual score of 3 or less:

    A. Esthetic Properties

    • Surface lustre [Item 1]
    • Staining (a) surface (b) margin [Item 2]
    • Color match and translucency [Item 3]
    • Esthetic anatomical form [Item 4]

    B. Functional Properties

    • Fracture of material and retention (a) qualitatively (b) quantitatively [Item 5]
    • Marginal adaptation [Item 6]
    • Wear [Item 7]
    • Approximal anatomical form (a) contact point (b) contour [Item 8]
    • Radiographic examination [Item 9]
    • Patient's view [Item 10]

    C. Biological Properties

    • Postoperative (hyper-)sensitivity and tooth vitality [Item 11]
    • Recurrence of caries (CAR), erosion, abfraction [Item 12]
    • Tooth integrity (enamel cracks, tooth fractures) [Item 13]
    • Periodontal response (always compared to a reference tooth) [Item 14]
    • Adjacent mucosa [Item 15]
    • Oral and general Health [Item 16]

  2. Percent success in Filtek Bulk Fill & Filtek Supreme Ultra composite resin restorations at Year 1 [ Time Frame: Baseline, Year 1 ]

    Cases will be considered successful if each of the 16 following World Dental Federation (FDI) criteria presents a individual score of 3 or less:

    A. Esthetic Properties

    • Surface lustre [Item 1]
    • Staining (a) surface (b) margin [Item 2]
    • Color match and translucency [Item 3]
    • Esthetic anatomical form [Item 4]

    B. Functional Properties

    • Fracture of material and retention (a) qualitatively (b) quantitatively [Item 5]
    • Marginal adaptation [Item 6]
    • Wear [Item 7]
    • Approximal anatomical form (a) contact point (b) contour [Item 8]
    • Radiographic examination [Item 9]
    • Patient's view [Item 10]

    C. Biological Properties

    • Postoperative (hyper-)sensitivity and tooth vitality [Item 11]
    • Recurrence of caries (CAR), erosion, abfraction [Item 12]
    • Tooth integrity (enamel cracks, tooth fractures) [Item 13]
    • Periodontal response (always compared to a reference tooth) [Item 14]
    • Adjacent mucosa [Item 15]
    • Oral and general Health [Item 16]

  3. Percent success in Filtek Bulk Fill & Filtek Supreme Ultra composite resin restorations at Year 3 [ Time Frame: Baseline, Year 3 ]

    Cases will be considered successful if each of the 16 following World Dental Federation (FDI) criteria presents a individual score of 3 or less:

    A. Esthetic Properties

    • Surface lustre [Item 1]
    • Staining (a) surface (b) margin [Item 2]
    • Color match and translucency [Item 3]
    • Esthetic anatomical form [Item 4]

    B. Functional Properties

    • Fracture of material and retention (a) qualitatively (b) quantitatively [Item 5]
    • Marginal adaptation [Item 6]
    • Wear [Item 7]
    • Approximal anatomical form (a) contact point (b) contour [Item 8]
    • Radiographic examination [Item 9]
    • Patient's view [Item 10]

    C. Biological Properties

    • Postoperative (hyper-)sensitivity and tooth vitality [Item 11]
    • Recurrence of caries (CAR), erosion, abfraction [Item 12]
    • Tooth integrity (enamel cracks, tooth fractures) [Item 13]
    • Periodontal response (always compared to a reference tooth) [Item 14]
    • Adjacent mucosa [Item 15]
    • Oral and general Health [Item 16]

  4. Percent success in Filtek Bulk Fill & Filtek Supreme Ultra composite resin restorations at Year 5 [ Time Frame: Baseline, Year 5 ]

    Cases will be considered successful if each of the 16 following World Dental Federation (FDI) criteria presents a individual score of 3 or less:

    A. Esthetic Properties

    • Surface lustre [Item 1]
    • Staining (a) surface (b) margin [Item 2]
    • Color match and translucency [Item 3]
    • Esthetic anatomical form [Item 4]

    B. Functional Properties

    • Fracture of material and retention (a) qualitatively (b) quantitatively [Item 5]
    • Marginal adaptation [Item 6]
    • Wear [Item 7]
    • Approximal anatomical form (a) contact point (b) contour [Item 8]
    • Radiographic examination [Item 9]
    • Patient's view [Item 10]

    C. Biological Properties

    • Postoperative (hyper-)sensitivity and tooth vitality [Item 11]
    • Recurrence of caries (CAR), erosion, abfraction [Item 12]
    • Tooth integrity (enamel cracks, tooth fractures) [Item 13]
    • Periodontal response (always compared to a reference tooth) [Item 14]
    • Adjacent mucosa [Item 15]
    • Oral and general Health [Item 16]

  5. Wear for Filtek Bulk Fill & Filtek Supreme Ultra composite resin restorations at 6 Months [ Time Frame: Baseline, 6 Months ]
    Wear measured in microns using digital scanning equipment (3M™ True Definition Scanner--3M ESPE)

  6. Wear for Filtek Bulk Fill & Filtek Supreme Ultra composite resin restorations at Year 1 [ Time Frame: Baseline, Year 1 ]
    Wear measured in microns using digital scanning equipment (3M™ True Definition Scanner--3M ESPE)

  7. Wear for Filtek Bulk Fill & Filtek Supreme Ultra composite resin restorations at Year 2 [ Time Frame: Baseline, Year 2 ]
    Wear measured in microns using digital scanning equipment (3M™ True Definition Scanner--3M ESPE)

  8. Wear for Filtek Bulk Fill & Filtek Supreme Ultra composite resin restorations at Year 3 [ Time Frame: Baseline, Year 3 ]
    Wear measured in microns using digital scanning equipment (3M™ True Definition Scanner--3M ESPE)

  9. Wear for Filtek Bulk Fill & Filtek Supreme Ultra composite resin restorations at Year 5 [ Time Frame: Baseline, Year 5 ]
    Wear measured in microns using digital scanning equipment (3M™ True Definition Scanner--3M ESPE)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be 18 years of age and older
  • Have a pair of similar cavities or failed dental fillings in vital permanent posterior teeth requiring treatment
  • Be capable of giving written informed consent.

Exclusion Criteria:

  • Have a self-reported history of any adverse reaction to materials of the types to be evaluated
  • Have a medical or dental history that could possibly complicate the provision of the proposed treatment and/or influence the behavior and performance of the treatment in clinical service.

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): NCT02572570


Locations
United States, North Carolina
University of North Carolina at Chapel Hill School of Dentistry Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Sherrill "S.T." Phillips    919-537-3905    Sherrill_Phillips@unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
3M ESPE
Investigators
Principal Investigator: Rick Walter, DDS University of North Carolina, Chapel Hill

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02572570     History of Changes
Other Study ID Numbers: 14-3097
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017

Keywords provided by University of North Carolina, Chapel Hill:
Adult dental care

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases