Skip to content

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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03462953
Enrollment
36
Registered
2018-03-13
Start date
2018-04-15
Completion date
2019-03-15
Last updated
2018-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis

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 .

Interventions

PROCEDUREGingival 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 .

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Localization of EMT indicators TGF- β1, Vimenten, E-Cadherinone yearusing 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

Contacts

Primary ContactKarim ghobrial, bachelor
karimwasfi3@gmail.com01203346668

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026