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Clinical Evaluation of Two Low-shrinkage Composites

Primary Purpose

Tooth Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Restorative materials- Filtek Silorane
Restorative materials-Kalore
Preparation-Er,Cr:YSGG Laser
Preparation- Diamond Bur
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Diseases

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. age range will be 18 to 60
  2. patients should have at least 4 occlusal caries lesions require restoration
  3. healty periodontal status
  4. a good likelihood of recall availability

Exclusion Criteria:

  1. poor gingival health
  2. adverse medical history
  3. potential behavioral problems

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Filtek Silorane-Er,Cr:YSGG Laser

    Filtek Silorane- Diamond Bur

    Kalore- Er,Cr:YSGG Laser

    Kalore- Diamond Bur

    Arm Description

    Outcomes

    Primary Outcome Measures

    Clinical performance of different low-shrinkage composites and preparations
    Evaluations according to FDI criteria

    Secondary Outcome Measures

    Full Information

    First Posted
    October 14, 2018
    Last Updated
    October 22, 2018
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03708510
    Brief Title
    Clinical Evaluation of Two Low-shrinkage Composites
    Official Title
    Clinical Evaluation of Two Low-shrinkage Composites After Different Preparation Techniques
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2011 (Actual)
    Primary Completion Date
    September 1, 2011 (Actual)
    Study Completion Date
    September 1, 2021 (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
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Patients with 4 occlusal lesions in molar teeth will be included. Occlusal cavities will be prepared either by Er,Cr:YSGG laser (LS) or conventional diamond bur (BR). Cavities will be restored with Filtek Silorane (3M-ESPE) (SR) and with Kalore (GC) (KR) according to the manufacturers' instructions. All restorative procedures will be performed by one operator and the restorations will be examined by two evaluators according to the FDI (World Dental Federation) criteria at baseline and at 6-month, 1-, 2-,3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-year. Patients' satisfaction about the preparation methods will be evaluated with a survey. Pearson Chi-Square test will be used for statistical analyze(p=0.05).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Filtek Silorane-Er,Cr:YSGG Laser
    Arm Type
    Experimental
    Arm Title
    Filtek Silorane- Diamond Bur
    Arm Type
    Experimental
    Arm Title
    Kalore- Er,Cr:YSGG Laser
    Arm Type
    Experimental
    Arm Title
    Kalore- Diamond Bur
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Restorative materials- Filtek Silorane
    Intervention Description
    Filtek Silorane
    Intervention Type
    Device
    Intervention Name(s)
    Restorative materials-Kalore
    Intervention Description
    Kalore
    Intervention Type
    Device
    Intervention Name(s)
    Preparation-Er,Cr:YSGG Laser
    Intervention Description
    Er,Cr:YSGG Laser
    Intervention Type
    Device
    Intervention Name(s)
    Preparation- Diamond Bur
    Intervention Description
    Bur
    Primary Outcome Measure Information:
    Title
    Clinical performance of different low-shrinkage composites and preparations
    Description
    Evaluations according to FDI criteria
    Time Frame
    10 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age range will be 18 to 60 patients should have at least 4 occlusal caries lesions require restoration healty periodontal status a good likelihood of recall availability Exclusion Criteria: poor gingival health adverse medical history potential behavioral problems

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Evaluation of Two Low-shrinkage Composites

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