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Three-Year Clinical Evaluation of Class II Posterior Composite Restorations

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aelite Flo
x-tra base
Sponsored by
Ondokuz Mayıs University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring composite resin, bulk-fill, teeth endodontically-treated

Eligibility Criteria

19 Years - 41 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Permanent premolars and molars without any restorations were included in the study. Every tooth included in the study had neighboring teeth and were in occlusion to antagonistic teeth.

Exclusion Criteria:

  • Patients were excluded who needed indirect restorations due to significant loss of tooth structure, known allergies to product ingredients, had poor oral hygiene and a history of bruxism.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Aelite Flo

    x-tra base

    Arm Description

    Microhybrid flowable composite

    Bulk-fill flowable composite

    Outcomes

    Primary Outcome Measures

    Clinical performance evaluation of different composite resin restorations with USPHS criteria
    Every year in three years period

    Secondary Outcome Measures

    Full Information

    First Posted
    July 26, 2016
    Last Updated
    August 3, 2016
    Sponsor
    Ondokuz Mayıs University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02858947
    Brief Title
    Three-Year Clinical Evaluation of Class II Posterior Composite Restorations
    Official Title
    Three-Year Clinical Evaluation of Class II Posterior Composite Restorations Placed With Different Techniques and Flowable Composite Linings in Endodontically Treated Teeth
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study was to investigate the clinical effectiveness of direct resin composite restorations placed with different placement techniques (incremental or bulk) and with different flowable linings (conventional or bulk-fill flowable) used in open-sandwich technique, in endodontically treated Class II cavities (mesio-occlusal or disto-occlusal), in a randomized controlled comparison.
    Detailed Description
    Forty-seven pairs Class II (mesio-occlusal or disto-occlusal) composite restorations were placed in 37 patients. In all cavities, Adper Single Bond 2 was used. In one of the cavities of each pair, a conventional flowable composite, Aelite Flo, was applied in approximately 2mm thick, and the remaining cavity was restored incrementally with GrandioSO. In the second cavity, a bulk-fill flowable composite, x-tra base, was applied in approximately 4 mm thick in bulk increments and the remaining 2mm occlusal part of the cavity was restored with GrandioSO. All cavities were restored with open-sandwich technique by the same operator. At baseline and after 6-month, 1-, 2- and 3-year follow-up visits, restorations were evaluated by Modified USPHS criteria.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries
    Keywords
    composite resin, bulk-fill, teeth endodontically-treated

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Aelite Flo
    Arm Type
    Active Comparator
    Arm Description
    Microhybrid flowable composite
    Arm Title
    x-tra base
    Arm Type
    Active Comparator
    Arm Description
    Bulk-fill flowable composite
    Intervention Type
    Procedure
    Intervention Name(s)
    Aelite Flo
    Other Intervention Name(s)
    1000006652
    Intervention Description
    Microhybrid flowable composite
    Intervention Type
    Procedure
    Intervention Name(s)
    x-tra base
    Other Intervention Name(s)
    1145403
    Intervention Description
    Bulk-fill flowable composite
    Primary Outcome Measure Information:
    Title
    Clinical performance evaluation of different composite resin restorations with USPHS criteria
    Description
    Every year in three years period
    Time Frame
    three years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    41 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Permanent premolars and molars without any restorations were included in the study. Every tooth included in the study had neighboring teeth and were in occlusion to antagonistic teeth. Exclusion Criteria: Patients were excluded who needed indirect restorations due to significant loss of tooth structure, known allergies to product ingredients, had poor oral hygiene and a history of bruxism.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Three-Year Clinical Evaluation of Class II Posterior Composite Restorations

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