HealthyNCT05923671
Clinical and Histological Analysis of Human Gingival Phenotypes
An observational study of Healthy, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Histological analysis and Immunohistochemical analysis
- How many people
- 45 participants
- Where
- 1 siteGreece
- Study dates
- 5 Mar 2020to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Healthy adults
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
Aristotle University of Thessaloniki
Thessaloniki, Macedonia, 54124
About this study
Official title: Clinical, Histological and Immunohistochemical Characterization 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Histological analysis, Immunohistochemical analysis
- Keywords
- gingiva, histological, immunohistochemical, periodontal, biotype, phenotype
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histological analysisDiagnostic test
Histological staining of gingival biopsies with haematoxylin-eosin.
Immunohistochemical analysisDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Thin Phenotype | Participants with transparent free gingiva of the maxillary central incisor Receives: Diagnostic Test: Histological analysis; Diagnostic Test: Immunohistochemical analysis | |
| Thick Phenotype | Participants with non-transparent free gingiva of the maxillary central incisor Receives: Diagnostic Test: Histological analysis; Diagnostic Test: Immunohistochemical analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell density
The number of all types of cells per square millimeter of the connective tissue
Measured: Baseline
Secondary outcomes (8)
Fibroblast Density
The number of fibroblasts per square millimeter of the connective tissue
Measured: Baseline
Macrophage Density
The number of macrophages per square millimeter of the connective tissue
Measured: Baseline
Density of Ki-67-positive cells
The number of Ki-67-positive cells per square millimeter of the connective tissue
Measured: Baseline
Density of Smooth Muscle Actin positive cells
The number of Smooth Muscle Actin positive cells per square millimeter of the connective tissue
Measured: Baseline
Collagen I area ratio
The percentage of the area of the connective tissue which is occupied by Collagen I
Measured: Baseline
Collagen V area ratio
The percentage of the area of the connective tissue which is occupied by Collagen V
Measured: Baseline
Elastin area ratio
The percentage of the area of the connective tissue which is occupied by Elastin
Measured: Baseline
Hyaluronic acid area ratio
The percentage of the area of the connective tissue which is occupied by Hyaluronic acid
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start5 Mar 2020
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- Umeå University
- Responsible party
- Sponsor
- Investigators
- Sotiris Kalfas, Professor, Study director, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923671
- Sponsor's protocol ID
- 1399
- Status last verified
- Jun 2023
- First submitted
- 22 Mar 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Histological and Immunohistochemical Characterization of Human Gingival Phenotypes
- ClinicalTrials.gov ID
- NCT05923671
- Acronym / sponsor ID
- 1399
- Conditions
- Healthy
- Keywords
- gingiva, histological, immunohistochemical, periodontal, biotype, phenotype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Umeå University
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thin Phenotype | – | Diagnostic Test: Histological analysis, Diagnostic Test: Immunohistochemical analysisParticipants with transparent free gingiva of the maxillary central incisor |
| Thick Phenotype | – | Diagnostic Test: Histological analysis, Diagnostic Test: Immunohistochemical analysisParticipants with non-transparent free gingiva of the maxillary central incisor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Histological analysisHistological staining of gingival biopsies with haematoxylin-eosin. | Diagnostic test | Thick Phenotype, Thin Phenotype |
| Immunohistochemical analysisImmunohistochemical 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. | Diagnostic test | Thick Phenotype, Thin Phenotype |
Primary outcome
Cell density
Time frame: Baseline
The number of all types of cells per square millimeter of the connective tissue
8 secondary outcomes
Fibroblast Density
Time frame: Baseline
Macrophage Density
Time frame: Baseline
Density of Ki-67-positive cells
Time frame: Baseline
Density of Smooth Muscle Actin positive cells
Time frame: Baseline
Collagen I area ratio
Time frame: Baseline
Collagen V area ratio
Time frame: Baseline
Elastin area ratio
Time frame: Baseline
Hyaluronic acid area ratio
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sotiris Kalfas, Professor study director
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cell density (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.