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Evaluation of Marginal Integrity of Hydroxyapatite Nano-Fiber Reinforced Flowable Composite Versus Conventional Resin-Based Flowable Composite in Initially Demineralized Pits and Fissure: A One Year, Randomized Clinical Trial

Primary Purpose

Marginal Integrity of Hydroxyapatite Nanofiber Reinforced Flowable Composite

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conventional resin-based flowable composite
Hydroxyapatite Nanofiber reinforced flowable composite
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Marginal Integrity of Hydroxyapatite Nanofiber Reinforced Flowable Composite

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients should be over 18 Years old.
  • Patient should have good oral hygiene and general health
  • With at least 2 non-cavitated initial occlusal carious lesion first and/or Second molar teeth in each quadrant of maxilla or mandible

Exclusion Criteria:

  • Known allergy to any of the resins used,
  • Clinically detectable caries,
  • Previously placed sealants or restorations,
  • Bruxism or malocclusion

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    conventional resin-based flowable composite

    Hydroxyapatite Nanofiber reinforced flowable composite

    Arm Description

    Outcomes

    Primary Outcome Measures

    marginal integrity of both restorations
    restorations will be reviewed after 12 months by two investigators who are blinded to the material used for the restorations. All restorations will be evaluated by calibrated examiners following the FDI criteria Data will be explored for normality using Kolmogrov-Smirnov test and Shapirowilk test. Comparisons between before and after treatment for normally distributed numeric variables will be done by Wilcoxon sign test. Comparisons between categorical variables will be performed using the chi square test Mcnemar test. A p-value less than or equal to 0.05 will be considered statistically significance. All tests will be two tailed.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 31, 2017
    Last Updated
    August 7, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03242291
    Brief Title
    Evaluation of Marginal Integrity of Hydroxyapatite Nano-Fiber Reinforced Flowable Composite Versus Conventional Resin-Based Flowable Composite in Initially Demineralized Pits and Fissure: A One Year, Randomized Clinical Trial
    Official Title
    Evaluation of Marginal Integrity of Hydroxyapatite Nano-Fiber Reinforced Flowable Composite Versus Conventional Resin-Based Flowable Composite in Initially Demineralized Pits and Fissure: A One Year, Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2017 (Anticipated)
    Primary Completion Date
    June 2018 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo 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
    This study will be conducted to evaluate the Marginal integrity of Hydroxyapatite Nanofiber reinforced flowable composite compared to a conventional resin-based flowable composite during management of initial carious lesion in adult population over a one year period.
    Detailed Description
    A total of 26 volunteer patients with at least 2 non-cavitated molar teeth will be assigned in this study. Patients will be divided into two groups according to type of flowable composite (R) where groups R1 the pits and fissure will be sealed with Hydroxyapatite Nanofiber reinforced flowable composite while groups R2 the pits and fissure will be sealed with conventional resin-based flowable composite. Each restoration will be assessed after one week, six and twelve months Both materials will be applied according to manufacturer's instructions where teeth should be cleaned to remove surface stains, then select appropriate shade of the flowable composite, A rubber dam is the preferred method of isolation, etch and rinse adhesive system is applied, where acid etching will be applied for 15 seconds then rinse and dry followed by application of adhesive then light cure 10 seconds, then place and cure in 2 mm increments of the flowable composite for 20 s., gently remove oxygen inhibition layer after light cure with slurry of pumice or polishing paste All restorations were reviewed after 1 week, 6, 12 months by two investigators who were blinded to the material used for the restorations. All restorations were be evaluated by calibrated examiners following the FDI criteria

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Marginal Integrity of Hydroxyapatite Nanofiber Reinforced Flowable Composite

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    26 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    conventional resin-based flowable composite
    Arm Type
    Active Comparator
    Arm Title
    Hydroxyapatite Nanofiber reinforced flowable composite
    Arm Type
    Other
    Intervention Type
    Other
    Intervention Name(s)
    Conventional resin-based flowable composite
    Intervention Description
    assessment of marginal integrity of Conventional resin-based flowable composite
    Intervention Type
    Other
    Intervention Name(s)
    Hydroxyapatite Nanofiber reinforced flowable composite
    Intervention Description
    assessment of marginal integrity of Hydroxyapatite Nanofiber reinforced flowable composite
    Primary Outcome Measure Information:
    Title
    marginal integrity of both restorations
    Description
    restorations will be reviewed after 12 months by two investigators who are blinded to the material used for the restorations. All restorations will be evaluated by calibrated examiners following the FDI criteria Data will be explored for normality using Kolmogrov-Smirnov test and Shapirowilk test. Comparisons between before and after treatment for normally distributed numeric variables will be done by Wilcoxon sign test. Comparisons between categorical variables will be performed using the chi square test Mcnemar test. A p-value less than or equal to 0.05 will be considered statistically significance. All tests will be two tailed.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients should be over 18 Years old. Patient should have good oral hygiene and general health With at least 2 non-cavitated initial occlusal carious lesion first and/or Second molar teeth in each quadrant of maxilla or mandible Exclusion Criteria: Known allergy to any of the resins used, Clinically detectable caries, Previously placed sealants or restorations, Bruxism or malocclusion
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    donia mamdouh elshafey, master
    Phone
    01008820027
    Ext
    002
    Email
    doniaelshafey90@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    mohamed mostafa radwan, PHD
    Phone
    01005148901
    Ext
    002
    Email
    mohamedmostafa23@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Evaluation of Marginal Integrity of Hydroxyapatite Nano-Fiber Reinforced Flowable Composite Versus Conventional Resin-Based Flowable Composite in Initially Demineralized Pits and Fissure: A One Year, Randomized Clinical Trial

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