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Clinical Comparison of Bulk-fill Restorative and Nano-fill Resin Composite

Primary Purpose

Dental Caries

Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bulk-fill
Nano-fill
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

24 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • a need for at least two but not more than four posterior tooth-colored restorations
  • the presence of teeth to be restored in occlusion
  • teeth that were symptomless and vital
  • a normal periodontal status
  • a good likelihood of recall availability.

Exclusion Criteria:

  • partly erupted teeth
  • absence of adjacent and antagonist teeth
  • poor periodontal status
  • adverse medical history
  • potential behavioral problems

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Bulk-fill resin composite

    Nano-fill resin composite

    Arm Description

    Bulk-fill resin composite will be places with bulk technique.

    Nano-fill resin composite will be placed with 2 mm thickness layering technique.

    Outcomes

    Primary Outcome Measures

    Marginal adaptation
    Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation will evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches will be performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1: Harmonious outline Alpha 2: Marginal gap (max 100μ) with discoloration (removable) Bravo: Marginal gap (> 100μ) with discoloration (unremovable) Charlie: The restoration is fractured or missed.
    Marginal discoloration
    Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding marginal discoloration. Marginal discoloration will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches will be performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
    Retention
    Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1:Clinically excellent Alpha 2: Clinically good with slight deviations from ideal performance, correction possible without damage of tooth or restoration Bravo: Clinically sufficient with few defects, corrections or repair of the restoration possible Charlie: Restoration is partially missed Delta: Restoration is totally missed
    Anatomic form
    Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding anatomic form. Anatomic form will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha 1: Continuous with existing anatomical form Alpha 2: Slightly discontinuous due to some chipping on the proximal ridge Bravo: Discontinuous with existing anatomical form due to material loss but proximal contact still present Charlie: Proximal contact is lost with ridge fracture.
    Color change
    Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding color change. Color changes will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failedand needs to be replaced. Alpha: The restoration matches the adjacent tooth structure in color and translucency. Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 22, 2020
    Last Updated
    March 22, 2020
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04320576
    Brief Title
    Clinical Comparison of Bulk-fill Restorative and Nano-fill Resin Composite
    Official Title
    Long-term Clinical Comparison of Bulk-fill and Nano-fill Composite Restorations
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    May 1, 2013 (Actual)
    Primary Completion Date
    February 1, 2020 (Actual)
    Study Completion Date
    May 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hacettepe University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to evaluate the clinical performance of a nano-fill and a bulk fill resin composite in class II restorations.
    Detailed Description
    In accordance with a split-mouth design, 50 patients will be received at least one pair of restorations, restored with a nanofill resin composite (Filtek Ultimate [FU]) and with a bulk fill resin composite (Tetric EvoCeram Bulk Fill [TB]). Each restorative resin will be used with its respective adhesive system according to the manufacturers' instructions. A total of 104 class II restorations will be placed by two operators. The restorations will be blindly evaluated by two examiners at baseline and at 1-, 2-, 3-, 4-, 5-, 6-, 7- and 8- year using modified US Public Health Service Ryge criteria. The comparison of the two restorative materials for each category will be performed with the chi-square test (a=0.05). The baseline scores will be compared with those at the recall visits using the Cochran Q-test.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Bulk-fill resin composite
    Arm Type
    Experimental
    Arm Description
    Bulk-fill resin composite will be places with bulk technique.
    Arm Title
    Nano-fill resin composite
    Arm Type
    Active Comparator
    Arm Description
    Nano-fill resin composite will be placed with 2 mm thickness layering technique.
    Intervention Type
    Device
    Intervention Name(s)
    Bulk-fill
    Intervention Description
    Bulk-fill resin composite (bulk technique)
    Intervention Type
    Device
    Intervention Name(s)
    Nano-fill
    Intervention Description
    Nano-fill resin composite (layering technique)
    Primary Outcome Measure Information:
    Title
    Marginal adaptation
    Description
    Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation will evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches will be performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1: Harmonious outline Alpha 2: Marginal gap (max 100μ) with discoloration (removable) Bravo: Marginal gap (> 100μ) with discoloration (unremovable) Charlie: The restoration is fractured or missed.
    Time Frame
    From baseline to 8 year the change of restorations will be evaluated
    Title
    Marginal discoloration
    Description
    Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding marginal discoloration. Marginal discoloration will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches will be performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
    Time Frame
    From baseline to 8 year the change of restorations will be evaluated
    Title
    Retention
    Description
    Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1:Clinically excellent Alpha 2: Clinically good with slight deviations from ideal performance, correction possible without damage of tooth or restoration Bravo: Clinically sufficient with few defects, corrections or repair of the restoration possible Charlie: Restoration is partially missed Delta: Restoration is totally missed
    Time Frame
    From baseline to 8 year the change of restorations will be evaluated
    Title
    Anatomic form
    Description
    Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding anatomic form. Anatomic form will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha 1: Continuous with existing anatomical form Alpha 2: Slightly discontinuous due to some chipping on the proximal ridge Bravo: Discontinuous with existing anatomical form due to material loss but proximal contact still present Charlie: Proximal contact is lost with ridge fracture.
    Time Frame
    From baseline to 8 year the change of restorations will be evaluated
    Title
    Color change
    Description
    Observers will evaluate the restorations will be performed using the modified United State Public Health Service criteria regarding color change. Color changes will be evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failedand needs to be replaced. Alpha: The restoration matches the adjacent tooth structure in color and translucency. Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency.
    Time Frame
    From baseline to 8 year the change of restorations will be evaluated

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    24 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: a need for at least two but not more than four posterior tooth-colored restorations the presence of teeth to be restored in occlusion teeth that were symptomless and vital a normal periodontal status a good likelihood of recall availability. Exclusion Criteria: partly erupted teeth absence of adjacent and antagonist teeth poor periodontal status adverse medical history potential behavioral problems
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ayse R Yazici, DDS, PhD
    Organizational Affiliation
    Hacettepe University School of Dentistry
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://www.ncbi.nlm.nih.gov/pubmed/28581919
    Description
    PUBMED
    URL
    https://www.ncbi.nlm.nih.gov/pubmed/29630489
    Description
    PUBMED

    Learn more about this trial

    Clinical Comparison of Bulk-fill Restorative and Nano-fill Resin Composite

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