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Identification of EMT Indicators in Healthy and Periodontally Diseased Gingival Samples

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ClinicalTrials.gov Identifier: NCT03462953
Recruitment Status : Not yet recruiting
First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Karim wasfi wadiea, Cairo University

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Procedure: Gingival tissue samples will be harvested Not Applicable

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:.

  1. Sections of 4-5 µm in thickness will be obtained, deparaffinized, rehydrated and subjected to histological staining and histomorphometric analysis.
  2. Real time- PCR for TGF-B1 ,Vimenten , E-Cadherin .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Localization of Indicators for Epithelial Mesenchymal Transformation in Gingiva From Chronic Periodontitis Patients as Compared to Healthy Individuals (Case Control Study)
Estimated Study Start Date : April 15, 2018
Estimated Primary Completion Date : August 15, 2018
Estimated Study Completion Date : March 15, 2019

Arm Intervention/treatment
Placebo Comparator: individuals with healthy gingiva
Gingival tissue samples will be harvested during the premolar extraction (Orthodontic ttt) or third molar extraction for the healthy controls.
Procedure: Gingival tissue samples will be harvested

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:.

  1. Sections of 4-5 µm in thickness will be obtained, deparaffinized, rehydrated and subjected to histological staining and histomorphometric analysis.
  2. Real time- PCR for TGF-B1 ,Vimenten , E-Cadherin .

Placebo Comparator: periodontally diseased individuals
Gingival tissue samples will be harvested during periodontal surgery and extraction of the periodontally hopeless tooth for the periodontitis patients.
Procedure: Gingival tissue samples will be harvested

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:.

  1. Sections of 4-5 µm in thickness will be obtained, deparaffinized, rehydrated and subjected to histological staining and histomorphometric analysis.
  2. Real time- PCR for TGF-B1 ,Vimenten , E-Cadherin .




Primary Outcome Measures :
  1. Localization of EMT indicators TGF- β1, Vimenten, E-Cadherin [ Time Frame: one year ]
    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



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462953


Contacts
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Contact: Karim ghobrial, bachelor 01203346668 karimwasfi3@gmail.com

Sponsors and Collaborators
Cairo University

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Responsible Party: Karim wasfi wadiea, Instructor at oral biology department at Mti university, Cairo University
ClinicalTrials.gov Identifier: NCT03462953     History of Changes
Other Study ID Numbers: CEBC-CU-2018-02-28
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases