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Identification of EMT Indicators in Healthy and Periodontally Diseased Gingival Samples

Primary Purpose

Chronic Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gingival tissue samples will be harvested
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Periodontitis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Inclusion criteria for healthy group:

    • Absence of any clinical sign of gingival inflammation
    • Probing depth ≤3 mm
    • No clinical attachment loss.

Inclusion criteria for periodontitis group:

  • Generalized presence of clinical signs of gingival inflammation
  • Generalized probing depth ≥4 mm
  • Generalized clinical attachment loss of ≥2 mm.

Exclusion Criteria:

  • • Patients with any systemic disease,

    • Smokers
    • Pregnant or lactating women,
    • Cervical/proximal/subgingival caries or restorations,
    • Periodontal or antimicrobial therapy within 3 months before sampling.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Placebo Comparator

    Arm Label

    individuals with healthy gingiva

    periodontally diseased individuals

    Arm Description

    Gingival tissue samples will be harvested during the premolar extraction (Orthodontic ttt) or third molar extraction for the healthy controls.

    Gingival tissue samples will be harvested during periodontal surgery and extraction of the periodontally hopeless tooth for the periodontitis patients.

    Outcomes

    Primary Outcome Measures

    Localization of EMT indicators TGF- β1, Vimenten, E-Cadherin
    using real time PCR the EMT indicators will be identified and quantified in all the gingival samples taken from patients of both arms of the study

    Secondary Outcome Measures

    Full Information

    First Posted
    March 4, 2018
    Last Updated
    March 9, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03462953
    Brief Title
    Identification of EMT Indicators in Healthy and Periodontally Diseased Gingival Samples
    Official Title
    Localization of Indicators for Epithelial Mesenchymal Transformation in Gingiva From Chronic Periodontitis Patients as Compared to Healthy Individuals (Case Control Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 15, 2018 (Anticipated)
    Primary Completion Date
    August 15, 2018 (Anticipated)
    Study Completion Date
    March 15, 2019 (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

    5. Study Description

    Brief Summary
    The current study focuses on the localization and quantitative assessment of growth factors and cytokines related to the EMT process found in the human gingival tissue samples taken from periodontally diseased individuals compared to other samples taken from healthy individuals. Through this investigation the correlation between the severity of the disease and the amount of these factors will be studied aiming to alleviation of the high prevalence of periodontal diseases among the Egyptian population.
    Detailed Description
    In a case control human study The existence and the amount of the indicators and cytokines for EMT in the gingival tissue samples taken from the periodontitis patients will be investigated and compared to those in healthy individuals using histopathology and real time PCR to reveal the role of these factors in periodontal disease incidence in humans. Total of 36 participants will be recruited in this study The participants will be divided according to their periodontal status into four groups (healthy, mild, moderate and severe periodontitis) 9 patients in each group. The periodontal screening of patients will be done using mouth mirror and graduated Williams's periodontal probe for the following: Gingival status will be assessed by using gingival index Periodontal pocket depth. Clinical attachment loss. Radiographic examination using panoramic technique. Screening criteria for chronic periodontitis was the presence of at least 5 sites with 4 mm horizontal alveolar bone loss on radiographs. Gingival tissue samples will be harvested during periodontal surgery and extraction of the periodontally hopeless tooth for the periodontitis patients and during the premolar extraction (Orthodontic ttt) or third molar extraction for the healthy controls. The dissected gingival samples will be washed in saline solution and fixed in 4% buffered formalin for 48 hours, dehydrated in ascending grades of ethyl alcohol, cleared in xylene and embedded in paraffin and will be subjected to the following:. Sections of 4-5 µm in thickness will be obtained, deparaffinized, rehydrated and subjected to histological staining and histomorphometric analysis. Real time- PCR for TGF-B1 ,Vimenten , E-Cadherin .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    individuals with healthy gingiva
    Arm Type
    Placebo Comparator
    Arm Description
    Gingival tissue samples will be harvested during the premolar extraction (Orthodontic ttt) or third molar extraction for the healthy controls.
    Arm Title
    periodontally diseased individuals
    Arm Type
    Placebo Comparator
    Arm Description
    Gingival tissue samples will be harvested during periodontal surgery and extraction of the periodontally hopeless tooth for the periodontitis patients.
    Intervention Type
    Procedure
    Intervention Name(s)
    Gingival tissue samples will be harvested
    Intervention Description
    Gingival tissue samples will be harvested during the premolar extraction (Orthodontic ttt) or third molar extraction for the healthy controls and during periodontal surgery or extraction of hopeless teeth with periodontal disease .. The dissected gingival samples will be washed in saline solution and fixed in 4% buffered formalin for 48 hours, dehydrated in ascending grades of ethyl alcohol, cleared in xylene and embedded in paraffin and will be subjected to the following:. Sections of 4-5 µm in thickness will be obtained, deparaffinized, rehydrated and subjected to histological staining and histomorphometric analysis. Real time- PCR for TGF-B1 ,Vimenten , E-Cadherin .
    Primary Outcome Measure Information:
    Title
    Localization of EMT indicators TGF- β1, Vimenten, E-Cadherin
    Description
    using real time PCR the EMT indicators will be identified and quantified in all the gingival samples taken from patients of both arms of the study
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Inclusion criteria for healthy group: Absence of any clinical sign of gingival inflammation Probing depth ≤3 mm No clinical attachment loss. Inclusion criteria for periodontitis group: Generalized presence of clinical signs of gingival inflammation Generalized probing depth ≥4 mm Generalized clinical attachment loss of ≥2 mm. Exclusion Criteria: • Patients with any systemic disease, Smokers Pregnant or lactating women, Cervical/proximal/subgingival caries or restorations, Periodontal or antimicrobial therapy within 3 months before sampling.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Karim ghobrial, bachelor
    Phone
    01203346668
    Email
    karimwasfi3@gmail.com

    12. IPD Sharing Statement

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    Identification of EMT Indicators in Healthy and Periodontally Diseased Gingival Samples

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