Identification of EMT Indicators in Healthy and Periodontally Diseased Gingival Samples
Localization of Indicators for Epithelial Mesenchymal Transformation in Gingiva From Chronic Periodontitis Patients as Compared to Healthy Individuals (Case Control Study)
Study Overview
Status
Conditions
Intervention / Treatment
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 .
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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:.
|
|
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.
|
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:.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
one year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEBC-CU-2018-02-28
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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