Identification of EMT Indicators in Healthy and Periodontally Diseased Gingival Samples

NCT03462953 | Unknown

• 1 other identifier: CEBC-CU-2018-02-28
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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

  one year

Study Arms (2)

individuals with healthy gingiva

PLACEBO COMPARATOR

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

periodontally diseased individuals

PLACEBO COMPARATOR

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

Interventions

Gingival tissue samples will be harvested 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 .

individuals with healthy gingiva; periodontally diseased individuals

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Karim ghobrial, bachelor

CONTACT

01203346668; karimwasfi3@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor at oral biology department at Mti university

Study Record Dates

• First Submitted: March 4, 2018
• First Posted: March 13, 2018
• Study Start: April 15, 2018
• Primary Completion: August 15, 2018
• Study Completion: March 15, 2019
• Last Updated: March 13, 2018

Record last verified: 2018-03