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Compariing a Bioactive Resin Material Used As A Fissure Sealant To A Conventional Resin

Primary Purpose

Demineralization, Tooth, Demineralization, Fissure, Non-Cavitated Caries

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fissure sealing
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Demineralization, Tooth

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with good oral hygiene
  • Co-operative patients with initially demineralized fissures in permanent molars of the maxilla or mandible

Exclusion Criteria:

  • Medical Problems or Pregnancy
  • Lack of patient's approval and compliance
  • Presence of abnormal oral, medical, or mental condition
  • Known allergy of resin-based materials
  • Previous placements of sealants or restorations
  • Bruxism or mal-occlusion

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Bioactive resin (Giomer)

    Conventional resin

    Arm Description

    This group of patients will receive a bioactive resin "Beautifil flow plus X (Shofu Dental)" for treatment of their demineralized fissures

    This group of patients will receive a conventional resin "Filtek Z350xt Flowable composite (3M ESPE)" for treatment of their demineralized fissures

    Outcomes

    Primary Outcome Measures

    Retention
    The sealing materials will be assessed for complete, partial or no retention. The assessment will be carried out by visual and tactile assessments and calculated as a percentage of the total sample.

    Secondary Outcome Measures

    Marginal integrity
    The materials margins will be assessed for their marginal seal using FDI criteria using a WHO probe. Scoring will be made from 1-5 by FDI criteria then statistically analyzed
    Caries progression
    The demineralized fissures will be monitored for caries arrest or progression. The assessment will be made by ICDAS II criteria comparing the scores from baseline.

    Full Information

    First Posted
    August 5, 2019
    Last Updated
    August 9, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04052802
    Brief Title
    Compariing a Bioactive Resin Material Used As A Fissure Sealant To A Conventional Resin
    Official Title
    The Efficacy Of A Bioactive Resin Material Used As A Fissure Sealant As Compared To A Conventional Resin Regarding Its Retention, Marginal Integrity And Prevention Of Lesion Progression. A Randomized Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 30, 2019 (Anticipated)
    Primary Completion Date
    March 30, 2021 (Anticipated)
    Study Completion Date
    April 30, 2021 (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
    The aim of this study is to investigate the retention, marginal integrity and potential to prevent lesion progression of a bioactive resin material compared to a conventional resin-based flowable composite during management of initial carious lesion in adult population over an 18 months period.
    Detailed Description
    Bio-active resin materials aim to possess the mechanical properties of resin materials in terms of higher wear resistance and dimensional stability over time. They also aim to mimic the biological activity of glass ionomers in terms of ion recharge and release. These new bio-active resin materials, with their lower particle size and better adaptability and polishability, might offer a substantial addition as fissure sealants if they fulfil the requisities satisfactory mechanical properties of resins and of ion recharge and release of glass ionomers. The study will be conducted on demineralized fissures of permanent molars by application of a newly introduced giomer in one group while the other group will recieve a conventional resin material where they will be assessed for retention, marginal integrity and caries progression.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Demineralization, Tooth, Demineralization, Fissure, Non-Cavitated Caries

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Bioactive resin (Giomer)
    Arm Type
    Experimental
    Arm Description
    This group of patients will receive a bioactive resin "Beautifil flow plus X (Shofu Dental)" for treatment of their demineralized fissures
    Arm Title
    Conventional resin
    Arm Type
    Experimental
    Arm Description
    This group of patients will receive a conventional resin "Filtek Z350xt Flowable composite (3M ESPE)" for treatment of their demineralized fissures
    Intervention Type
    Other
    Intervention Name(s)
    Fissure sealing
    Intervention Description
    The materials will be applied to the demineralized fissures as stated in manufacturer's instructions
    Primary Outcome Measure Information:
    Title
    Retention
    Description
    The sealing materials will be assessed for complete, partial or no retention. The assessment will be carried out by visual and tactile assessments and calculated as a percentage of the total sample.
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    Marginal integrity
    Description
    The materials margins will be assessed for their marginal seal using FDI criteria using a WHO probe. Scoring will be made from 1-5 by FDI criteria then statistically analyzed
    Time Frame
    18 months
    Title
    Caries progression
    Description
    The demineralized fissures will be monitored for caries arrest or progression. The assessment will be made by ICDAS II criteria comparing the scores from baseline.
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with good oral hygiene Co-operative patients with initially demineralized fissures in permanent molars of the maxilla or mandible Exclusion Criteria: Medical Problems or Pregnancy Lack of patient's approval and compliance Presence of abnormal oral, medical, or mental condition Known allergy of resin-based materials Previous placements of sealants or restorations Bruxism or mal-occlusion

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The data will be assessed collectively for ll participants and statistically analyzed and published with the results. Other data can be provided apon request if ethically approved.

    Learn more about this trial

    Compariing a Bioactive Resin Material Used As A Fissure Sealant To A Conventional Resin

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