Clinical and Histological Analysis of Human Gingival Phenotypes

NCT ID: NCT05923671

Last Updated: 2023-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-05

Study Completion Date

2022-12-01

Brief Summary

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The goal of this observational study is to compare the composition of the human gingiva in different gingival phenotypes. The main questions to answer are:

* Is there any difference in the cellular composition of the gingiva between thin and thick gingival phenotype?
* Is there any difference in the molecular composition of the gingiva between thin and thick gingival phenotype?

The participants were divided in two groups (thin and thick phenotype) and a biopsy of healthy gingiva was obtained from each one them. The biopsies were analyzed histologically and the collected data will be analyzed statistically in order to identify possible differences between the gingival phenotypes.

Detailed Description

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Healthy volunteers were assigned in one of two groups:

* Group 1: Thin gingiva, when the free gingiva was evaluated as transparent, after the insertion of a periodontal probe (Hu-Friedy XP-23/QW, Hu-Friedy,Chicago,IL,USA) in the middle of the facial dentogingival sulcus of a maxillary central incisor
* Group 2: Thick gingiva: when the free gingiva was evaluated as non-transparent, using the same methodology.

A full thickness sample of the oral mucosa of each one of the participants was collected under local anaesthesia. The sample had a rectangular shape, with a length of 4 millimeters and a width of 1 millimeter. It had a vertical orientation and it was expanding at the both sides of the mucogingival junction.

The oral mucosa samples were processed for histological and immunohistochemical analysis. Staining with haematoxylin-eosin was performed in order to describe the tissue histologically and also calculate the total number of the cells it contained. Immunohistochemical staining with anti-Vimentin,anti-Cluster of Differentiation 68, anti-Ki-67 and anti-Smooth Muscle Actin antibodies was applied for the calculation of the numbers of fibroblasts, macrophages, Ki-67-positive cells and Smooth muscle actin positive cells respectively. Immunohistochemical staining was also performed in order to determine the levels of expression of Collagen I, Collagen V, Elastin and Hyaluronic acid.

Whole slide images of the specimens were acquired with the use of the NanoZoomer 2.0HT (Hamamatsu Pho-tonics K.K., Hamamatsu, Japan). Cell counting will be performed automatically using an image analysis software (QuPath 3.0). The levels of molecular expression will be assessed with the use of the same software and will be expressed as a percentage of the area of the connective tissue that is occupied by the investigated molecules.

Conditions

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Healthy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Thin Phenotype

Participants with transparent free gingiva of the maxillary central incisor

Histological analysis

Intervention Type DIAGNOSTIC_TEST

Histological staining of gingival biopsies with haematoxylin-eosin.

Immunohistochemical analysis

Intervention Type DIAGNOSTIC_TEST

Immunohistochemical staining of gingival biopsies using anti-Vimentin, anti-Collagen I, anti-Collagen V, anti-Elastin, anti-Hyaluronic acid, anti-Smooth muscle actin, anti-Cluster of Differentiation 68 and anti-ki67 antibodies.

Thick Phenotype

Participants with non-transparent free gingiva of the maxillary central incisor

Histological analysis

Intervention Type DIAGNOSTIC_TEST

Histological staining of gingival biopsies with haematoxylin-eosin.

Immunohistochemical analysis

Intervention Type DIAGNOSTIC_TEST

Immunohistochemical staining of gingival biopsies using anti-Vimentin, anti-Collagen I, anti-Collagen V, anti-Elastin, anti-Hyaluronic acid, anti-Smooth muscle actin, anti-Cluster of Differentiation 68 and anti-ki67 antibodies.

Interventions

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Histological analysis

Histological staining of gingival biopsies with haematoxylin-eosin.

Intervention Type DIAGNOSTIC_TEST

Immunohistochemical analysis

Immunohistochemical staining of gingival biopsies using anti-Vimentin, anti-Collagen I, anti-Collagen V, anti-Elastin, anti-Hyaluronic acid, anti-Smooth muscle actin, anti-Cluster of Differentiation 68 and anti-ki67 antibodies.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Healthy adults

Exclusion Criteria

* Attachment loss or Probing depths greater than 2 millimeters at the maxillary central incisors
* Altered passive eruption of the maxillary incisors
* Previous surgery or orthodontic treatment in the anterior maxilla
* Medical conditions or medication affecting soft tissue metabolism
* Tooth crowding or abnormal angulation or abrasion of the maxillary incisors
* Restorations at the buccal surface of the maxillary central incisors
* Smoking
* Pregnancy or lactation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Umeå University

OTHER

Sponsor Role collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sotiris Kalfas, Professor

Role: STUDY_DIRECTOR

Aristotle University Of Thessaloniki

Locations

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Aristotle University of Thessaloniki

Thessaloniki, Macedonia, Greece

Site Status

Countries

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Greece

Other Identifiers

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1399

Identifier Type: -

Identifier Source: org_study_id

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