Clinical and Histological Analysis of Human Gingival Phenotypes

NCT05923671 | Completed

• 1 other identifier: 1399
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

gingiva; histological; immunohistochemical; periodontal; biotype; phenotype

Outcome Measures

Primary Outcomes (1)

• Cell density

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

  Baseline

Secondary Outcomes (8)

• Fibroblast Density

  Baseline

• Macrophage Density

  Baseline

• Density of Ki-67-positive cells

  Baseline

• Density of Smooth Muscle Actin positive cells

  Baseline

• Collagen I area ratio

  Baseline

Other Outcomes (2)

• Keratinized tissue width

  Baseline

• Gingival thickness

  Baseline

Study Arms (2)

Thin Phenotype

Participants with transparent free gingiva of the maxillary central incisor

Diagnostic Test: Histological analysis; Diagnostic Test: Immunohistochemical analysis

Thick Phenotype

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

Diagnostic Test: Histological analysis; Diagnostic Test: Immunohistochemical analysis

Interventions

Histological analysis DIAGNOSTIC_TEST

Histological staining of gingival biopsies with haematoxylin-eosin.

Thick Phenotype; Thin Phenotype

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.

Thick Phenotype; Thin Phenotype

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy volunteers referred to the Department of Preventive Dentistry, Periodontology and Implant Biology of the Dental School of the Aristotle University of Thessaloniki.

You may qualify if:

• Healthy adults

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Umeå University: collaborator

Study Sites (1)

Aristotle University of Thessaloniki

Thessaloniki, Macedonia, 54124, Greece

Location

Study Officials

• Sotiris Kalfas, Professor

  Aristotle University Of Thessaloniki

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: June 28, 2023
• Study Start: March 5, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 28, 2023

Record last verified: 2023-06

Locations

GR (1)