Identification of EMT Indicators in Healthy and Periodontally Diseased Gingival Samples

NCT ID: NCT03462953

Last Updated: 2018-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-15
• Study Completion Date: 2019-03-15

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:.

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 .

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

individuals with healthy gingiva

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

Group Type: PLACEBO_COMPARATOR

Gingival tissue samples will be harvested

Intervention Type: PROCEDURE

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 .

periodontally diseased individuals

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

Group Type: PLACEBO_COMPARATOR

Gingival tissue samples will be harvested

Intervention Type: PROCEDURE

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 .

Interventions

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 .

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Karim wasfi wadiea

Instructor at oral biology department at Mti university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Karim ghobrial, bachelor

Role: CONTACT

karimwasfi3@gmail.com

01203346668

Other Identifiers

CEBC-CU-2018-02-28

Identifier Type: -

Identifier Source: org_study_id