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Completed

NCT Number: NCT05923671

Clinical and Histological Analysis of Human Gingival Phenotypes

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aristotle University of Thessaloniki

Thessaloniki, Macedonia, 54124, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Histological analysis

Diagnostic Test

Histological staining of gingival biopsies with haematoxylin-eosin.

Immunohistochemical analysis

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.

Primary outcomes

  1. Cell density

    Time frame: Baseline

    The number of all types of cells per square millimeter of the connective tissue

Secondary outcomes

  1. Fibroblast Density

    Time frame: Baseline

    The number of fibroblasts per square millimeter of the connective tissue

  2. Macrophage Density

    Time frame: Baseline

    The number of macrophages per square millimeter of the connective tissue

  3. Density of Ki-67-positive cells

    Time frame: Baseline

    The number of Ki-67-positive cells per square millimeter of the connective tissue

  4. Density of Smooth Muscle Actin positive cells

    Time frame: Baseline

    The number of Smooth Muscle Actin positive cells per square millimeter of the connective tissue

  5. Collagen I area ratio

    Time frame: Baseline

    The percentage of the area of the connective tissue which is occupied by Collagen I

  6. Collagen V area ratio

    Time frame: Baseline

    The percentage of the area of the connective tissue which is occupied by Collagen V

  7. Elastin area ratio

    Time frame: Baseline

    The percentage of the area of the connective tissue which is occupied by Elastin

  8. Hyaluronic acid area ratio

    Time frame: Baseline

    The percentage of the area of the connective tissue which is occupied by Hyaluronic acid

Other outcomes

  1. Keratinized tissue width

    Time frame: Baseline

    The length (millimeters) of the line that connects the mucogingival junction and the gingival margin, at the middle of the facial surface of the maxillary central incisor

  2. Gingival thickness

    Time frame: Baseline

    The thickness (millimeters) of the gingiva, measured with an ultrasonic biometer (PIROP Biometric scanner, ECHO-SON S.A., Poland) at the middle of the line that connects the mucogingival junction and the gingival margin, at the middle of the facial surface of the maxillary central incisor

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • Umeå University

Registry information

Official study title

Clinical, Histological and Immunohistochemical Characterization of Human Gingival Phenotypes

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2023
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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