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
About this trial
This is an interventional basic science trial for Chronic Periodontitis
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.
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
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
Learn more about this trial
Identification of EMT Indicators in Healthy and Periodontally Diseased Gingival Samples
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