Clinical and Histological Analysis of Human Gingival Phenotypes
NCT ID: NCT05923671
Last Updated: 2023-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
45 participants
OBSERVATIONAL
2020-03-05
2022-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Biomarkers Levels in Gingival Crevicular Fluid, Saliva and Serum for Different Periodontal Diseases
NCT05435131
Evaluation of GCF And Salivary Ferritin, ALP And MMP-8 Levels of Individuals With Different Periodontal Diseases
NCT06561802
Serum A.Actinomycetemcomitans Antibodies and Periodontitis
NCT04417322
Cytokine and MMP Levels in Gingival Crevicular Fluid in the Treatment of Localized Gingival Recessions
NCT02380872
Identification of EMT Indicators in Healthy and Periodontally Diseased Gingival Samples
NCT03462953
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Thin Phenotype
Participants with transparent free gingiva of the maxillary central incisor
Histological analysis
Histological staining of gingival biopsies with haematoxylin-eosin.
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.
Thick Phenotype
Participants with non-transparent free gingiva of the maxillary central incisor
Histological analysis
Histological staining of gingival biopsies with haematoxylin-eosin.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Histological analysis
Histological staining of gingival biopsies with haematoxylin-eosin.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Umeå University
OTHER
Aristotle University Of Thessaloniki
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sotiris Kalfas, Professor
Role: STUDY_DIRECTOR
Aristotle University Of Thessaloniki
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aristotle University of Thessaloniki
Thessaloniki, Macedonia, Greece
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1399
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.