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Clinical Performance of Incremental and Bulk Fill Composites in Class II Restorations

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ClinicalTrials.gov Identifier: NCT02889835
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
3M

Brief Summary:
This study will examine the clinical performance of Class II restorations over a three year period with 3 composite resins - a conventional composite resin, a flowable composite resin and a bulk placed and cured composite resin.

Condition or disease Intervention/treatment Phase
Dental Caries Device: Supreme Universal Restorative Device: Supreme Flowable Restorative Device: Bulk Fill Flowable Restorative Not Applicable

Detailed Description:
Specific Aim: To place three commercially available resin composites in Class II cavity preparations of adult patients, evaluate the resin composite restorations at baseline, 6 months, 1 year, 2 and 3 years using specific criteria (direct and indirect).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: "Clinical Performance of an Incrementally Placed Highly Filled Composite, an Incrementally Placed Flowable Composite, and a Bulk Filled Composite in Class II Restorations"
Actual Study Start Date : March 22, 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Universal Composite
Supreme Universal Restorative
Device: Supreme Universal Restorative
Experimental: Flowable Composite
Supreme Flowable Restorative
Device: Supreme Flowable Restorative
Experimental: Bulk Fill Flowable Composite
Bulk Fill Flowable Restorative
Device: Bulk Fill Flowable Restorative



Primary Outcome Measures :
  1. Percent Acceptable Restorations [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Anatomic Form [ Time Frame: 6 Months ]

    A = The restoration is continuous with existing form. B = The restoration is discontinuous with existing anatomic form, but the existing material is not sufficient to expose dentine.

    C = Sufficient material lost to expose dentine or lining material.


  2. Anatomic Form [ Time Frame: 1 Year ]

    A = The restoration is continuous with existing form. B = The restoration is discontinuous with existing anatomic form, but the existing material is not sufficient to expose dentine.

    C = Sufficient material lost to expose dentine or lining material.


  3. Anatomic Form [ Time Frame: 2 Year ]

    A = The restoration is continuous with existing form. B = The restoration is discontinuous with existing anatomic form, but the existing material is not sufficient to expose dentine.

    C = Sufficient material lost to expose dentine or lining material.


  4. Anatomic Form [ Time Frame: 3 Year ]

    A = The restoration is continuous with existing form. B = The restoration is discontinuous with existing anatomic form, but the existing material is not sufficient to expose dentine.

    C = Sufficient material lost to expose dentine or lining material.


  5. Color Match [ Time Frame: 6 Month ]

    A = The restoration appears to match the shade and translucency of adjacent tooth structure.

    B = The restoration does not match the shade and translucency of adjacent tooth structure, but the mismatch is within the normal range of tooth shades and translucency.

    C = The restoration does not match the shade and translucency of the adjacent tooth structure, and the mismatch is outside the normal range of tooth shades and translucency.


  6. Color Match [ Time Frame: 1 Year ]

    A = The restoration appears to match the shade and translucency of adjacent tooth structure.

    B = The restoration does not match the shade and translucency of adjacent tooth structure, but the mismatch is within the normal range of tooth shades and translucency.

    C = The restoration does not match the shade and translucency of the adjacent tooth structure, and the mismatch is outside the normal range of tooth shades and translucency.


  7. Color Match [ Time Frame: 2 Year ]

    A = The restoration appears to match the shade and translucency of adjacent tooth structure.

    B = The restoration does not match the shade and translucency of adjacent tooth structure, but the mismatch is within the normal range of tooth shades and translucency.

    C = The restoration does not match the shade and translucency of the adjacent tooth structure, and the mismatch is outside the normal range of tooth shades and translucency.


  8. Color Match [ Time Frame: 3 Year ]

    A = The restoration appears to match the shade and translucency of adjacent tooth structure.

    B = The restoration does not match the shade and translucency of adjacent tooth structure, but the mismatch is within the normal range of tooth shades and translucency.

    C = The restoration does not match the shade and translucency of the adjacent tooth structure, and the mismatch is outside the normal range of tooth shades and translucency.


  9. Margin Adaptation [ Time Frame: 6 Month ]

    A = No visible evidence of a crevice along the margin into which the explorer will penetrate.

    B = Visible evidence of a crevice, and dentin or base is exposed. C = Explorer penetrates into crevice, and dentin or base is exposed. D = Restoration is mobile, fractured or missing.


  10. Margin Adaptation [ Time Frame: 1 Year ]

    A = No visible evidence of a crevice along the margin into which the explorer will penetrate.

    B = Visible evidence of a crevice, and dentin or base is exposed. C = Explorer penetrates into crevice, and dentin or base is exposed. D = Restoration is mobile, fractured or missing.


  11. Margin Adaptation [ Time Frame: 2 Year ]

    A = No visible evidence of a crevice along the margin into which the explorer will penetrate.

    B = Visible evidence of a crevice, and dentin or base is exposed. C = Explorer penetrates into crevice, and dentin or base is exposed. D = Restoration is mobile, fractured or missing.


  12. Margin Adaptation [ Time Frame: 3 Year ]

    A = No visible evidence of a crevice along the margin into which the explorer will penetrate.

    B = Visible evidence of a crevice, and dentin or base is exposed. C = Explorer penetrates into crevice, and dentin or base is exposed. D = Restoration is mobile, fractured or missing.


  13. Margin Discoloration [ Time Frame: 6 Month ]

    A = There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color the adjacent tooth structure.

    B = There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction.

    C = There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has penetrated along the restoration in a pulpal direction.


  14. Margin Discoloration [ Time Frame: 1 Year ]

    A = There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color the adjacent tooth structure.

    B = There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction.

    C = There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has penetrated along the restoration in a pulpal direction.


  15. Margin Discoloration [ Time Frame: 2 Year ]

    A = There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color the adjacent tooth structure.

    B = There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction.

    C = There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has penetrated along the restoration in a pulpal direction.


  16. Margin Discoloration [ Time Frame: 3 Year ]

    A = There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color the adjacent tooth structure.

    B = There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction.

    C = There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has penetrated along the restoration in a pulpal direction.


  17. Proximal Contacts [ Time Frame: 6 Months ]
    A = Tight proximal contacts evaluated with dental floss. B = Proximal contacts are weak but present. C = No proximal contacts but not visibly open. D = Visibly open contacts.

  18. Proximal Contacts [ Time Frame: 1 Year ]
    A = Tight proximal contacts evaluated with dental floss. B = Proximal contacts are weak but present. C = No proximal contacts but not visibly open. D = Visibly open contacts.

  19. Proximal Contacts [ Time Frame: 2 Year ]
    A = Tight proximal contacts evaluated with dental floss. B = Proximal contacts are weak but present. C = No proximal contacts but not visibly open. D = Visibly open contacts.

  20. Proximal Contacts [ Time Frame: 3 Year ]
    A = Tight proximal contacts evaluated with dental floss. B = Proximal contacts are weak but present. C = No proximal contacts but not visibly open. D = Visibly open contacts.

  21. Caries [ Time Frame: 6 Months ]
    A = Absent B = Present

  22. Caries [ Time Frame: 1 Year ]
    A = Absent B = Present

  23. Caries [ Time Frame: 2 Year ]
    A = Absent B = Present

  24. Caries [ Time Frame: 3 Year ]
    A = Absent B = Present

  25. Sensitivity [ Time Frame: 6 Months ]
    Visual to Analog scale; 0=no pain, 10=maximum pain

  26. Sensitivity [ Time Frame: 1 Year ]
    Visual to Analog scale; 0=no pain, 10=maximum pain

  27. Sensitivity [ Time Frame: 2 Year ]
    Visual to Analog scale; 0=no pain, 10=maximum pain

  28. Sensitivity [ Time Frame: 3 Year ]
    Visual to Analog scale; 0=no pain, 10=maximum pain



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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • must have given written informed consent to participate in the trial
  • must need at least three posterior dental fillings
  • replacement restorations due to caries or an esthetic replacement with or without caries are acceptable.
  • must be available for the required post-operative follow-up visits
  • restorations must be in contact with opposing natural or crowned teeth with at least at least one occlusal contact in habitual closure
  • Class II restorations must have at least one proximal contact
  • restorations must have a buccal to lingual/palatal width no greater than 1/3 the distance from buccal to lingual/palatal cusp tips
  • all restorations must Class II with a proximal contact with a natural or artificial tooth

Exclusion Criteria:

  • have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or immunocompromised) and disabilities who may not be able to tolerate the time required to complete the restorations or to provide adequate oral hygiene
  • have xerostomia either by taking medications known to produce xerostomia or those with radiation induced or Sjogren's syndrome patients
  • have chronic periodontitis, rampant caries or poor oral hygiene which may require extraction of the teeth to be restored
  • are unavailable for long term recall
  • cannot tolerate the rubber dam required for isolation of the tooth during preparation and restoration.
  • do not meet all inclusion criteria
  • present with any systemic or local disorders that contra-indicate the dental procedures included in this study
  • have an unstable occlusion
  • have severe bruxing or clenching or in need of TMJ related therapy
  • have teeth with periapical pathology or expected pulp exposures
  • have teeth that are non-vital or that exhibit signs of pulpal pathology
  • are pregnant.

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): NCT02889835


Contacts
Contact: LaTara Rogers 205-996-5747 mztara@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Dental School Recruiting
Birmingham, Alabama, United States, 35233-2005
Contact: LaTara Rogers    205-996-5747    mztara@uab.edu   
Sponsors and Collaborators
3M

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT02889835     History of Changes
Other Study ID Numbers: CR16-005
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by 3M:
Class II
molar and premolar
resin composite
adult
restoration

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