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Clinical and Histological Analysis of Human Gingival Phenotypes

Clinical, Histological and Immunohistochemical Characterization of Human Gingival Phenotypes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05923671
Enrollment
45
Registered
2023-06-28
Start date
2020-03-05
Completion date
2022-12-01
Last updated
2023-06-28

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

Conditions

Healthy

Keywords

gingiva, histological, immunohistochemical, periodontal, biotype, phenotype

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTHistological analysis

Histological staining of gingival biopsies with haematoxylin-eosin.

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.

Sponsors

Umeå University
CollaboratorOTHER
Aristotle University Of Thessaloniki
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Cell densityBaselineThe number of all types of cells per square millimeter of the connective tissue

Secondary

MeasureTime frameDescription
Fibroblast DensityBaselineThe number of fibroblasts per square millimeter of the connective tissue
Macrophage DensityBaselineThe number of macrophages per square millimeter of the connective tissue
Density of Ki-67-positive cellsBaselineThe number of Ki-67-positive cells per square millimeter of the connective tissue
Density of Smooth Muscle Actin positive cellsBaselineThe number of Smooth Muscle Actin positive cells per square millimeter of the connective tissue
Elastin area ratioBaselineThe percentage of the area of the connective tissue which is occupied by Elastin
Hyaluronic acid area ratioBaselineThe percentage of the area of the connective tissue which is occupied by Hyaluronic acid
Collagen I area ratioBaselineThe percentage of the area of the connective tissue which is occupied by Collagen I
Collagen V area ratioBaselineThe percentage of the area of the connective tissue which is occupied by Collagen V

Other

MeasureTime frameDescription
Keratinized tissue widthBaselineThe 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
Gingival thicknessBaselineThe 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

Countries

Greece

Outcome results

None listed

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