Peripheral Giant Cell GranulomaNCT07551310
Lymphocyte Subpopulations in Peripheral Giant Cell Granuloma
An observational study of Peripheral Giant Cell Granuloma and Gingival Lesions, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Peripheral giant cell granuloma (PGCG) is a non-neoplastic inflammatory lesion of gingival tissues. This study aims to evaluate and compare lymphocyte subpopulations in PGCG tissues and adjacent healthy gingival tissues obtained from the same individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peripheral Giant Cell Granuloma, Gingival Lesions, Gingival Enlargement
- What is being tested?
- Immunohistochemical Analysis
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 30 Mar 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of 28 systemically healthy, non-smoking patients diagnosed with peripheral giant cell granuloma (PGCG).
Who may be able to join
- Systemically healthy individuals
- Non-smokers
- Patients diagnosed with peripheral giant cell granuloma
- Individuals requiring surgical excision of PGCG
- Patients providing written informed consent
Who cannot join
- Presence of systemic diseases
- Smoking habit
- Use of medications associated with gingival enlargement
- History of periodontal treatment within the last 6 months
- Pregnant or lactating individuals
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Faculty of Dentistry
Erzurum, Malatya, 5444155691
About this study
Official title: Immunohistochemical Evaluation of Lymphocyte Subpopulations in Peripheral Giant Cell Granuloma and Healthy Gingival Tissues: A Within-Subject Controlled Study
Peripheral giant cell granuloma (PGCG) is a non-neoplastic inflammatory lesion of gingival tissues. This study aims to evaluate and compare lymphocyte subpopulations in PGCG tissues and adjacent healthy gingival tissues obtained from the same individuals.
A total of 28 systemically healthy, non-smoking patients diagnosed with PGCG are included in this study. Biopsy samples are collected during surgical excision of PGCG lesions, and corresponding healthy gingival tissues are obtained from the same patients.
Immunohistochemical analysis is performed to assess lymphocyte subpopulations, including CD3, CD4, CD8, CD20, and CD79a. The proportions of these cells are compared between diseased and healthy tissues.
Read the detailed description
Peripheral giant cell granuloma (PGCG) is a relatively common non-neoplastic inflammatory lesion of the gingiva characterized by multinucleated giant cells within a vascularized stroma. Lymphocyte subpopulations, including T- and B-cells, play a significant role in the immunopathogenesis of gingival and periodontal diseases.
The evaluation of lymphocyte subpopulations in gingival tissues is an established method for understanding local immune responses. However, limited data are available regarding lymphocyte profiles in PGCG lesions. Therefore, this study aims to investigate and compare lymphocyte subpopulations in PGCG and healthy gingival tissues.
This study is designed as a within-subject controlled observational study including 28 systemically healthy and non-smoking patients diagnosed with PGCG. Biopsy samples are obtained from PGCG lesions during surgical excision, and corresponding healthy gingival tissues are collected from the same individuals.
Tissue specimens are processed using standard histological procedures and analyzed by immunohistochemical methods. The presence and proportion of CD3, CD4, CD8, CD20, and CD79a positive cells are evaluated. The proportion of positively stained cells is calculated as the percentage of positive cells relative to the total number of counted cells.
The results are compared between PGCG tissues and healthy gingival tissues to identify differences in lymphocyte subpopulations and to better understand the immunopathological characteristics of PGCG.
- Being tested
- Immunohistochemical Analysis
- Keywords
- Lymphocyte Subpopulations, Immunohistochemistry, Gingival Tissue, Oral Pathology, Periodontal Disease, Inflammatory Lesions
- Medical subject headings
- Granuloma, Giant Cell, Gingival Hyperplasia, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunohistochemical AnalysisDiagnostic test
Immunohistochemical staining is performed on gingival tissue samples to evaluate lymphocyte subpopulations, including CD3, CD4, CD8, CD20, and CD79a. The proportion of positively stained cells is determined by calculating the percentage of positive cells relative to the total number of counted cells.
| Study group | Role | What they receive |
|---|---|---|
| PGCG Tissue | Biopsy samples obtained from peripheral giant cell granuloma lesions during surgical excision. Receives: Diagnostic Test: Immunohistochemical Analysis | |
| Healthy Gingival Tissue | Biopsy samples obtained from adjacent healthy gingival tissues of the same patients. Receives: Diagnostic Test: Immunohistochemical Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Lymphocyte Subpopulations
The proportion of CD3, CD4, CD8, CD20, and CD79a positive cells is determined by calculating the percentage of positively stained cells relative to the total number of counted cells in gingival tissue samples.
Measured: At the time of tissue analysis (baseline)
Secondary outcomes (1)
CD4/CD8 Ratio
The ratio of CD4 positive cells to CD8 positive cells is calculated to evaluate differences in lymphocyte subpopulations.
Measured: At the time of tissue analysis (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Jan 2026
- Primary completion1 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Giant Cell GranulomaStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alparslan Dilsiz, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551310
- Sponsor's protocol ID
- ATAUNI-PGCG-2026
- Status last verified
- May 2026
- First submitted
- 18 Apr 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy concerns and the sensitive nature of patient-derived tissue samples. The dataset is limited in size and contains potentially identifiable information.
Publications
Dilsiz A, Gürsan N, Aydın T. Immunohistochemical analysis of lymphocyte subpopulation in normal gingiva and peripheral giant cell granuloma. Journal of Clinical Periodontology. 2012;39(Suppl 13):97.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunohistochemical Evaluation of Lymphocyte Subpopulations in Peripheral Giant Cell Granuloma and Healthy Gingival Tissues: A Within-Subject Controlled Study
- ClinicalTrials.gov ID
- NCT07551310
- Acronym / sponsor ID
- ATAUNI-PGCG-2026
- Keywords
- Lymphocyte Subpopulations, Immunohistochemistry, Gingival Tissue, Oral Pathology, Periodontal Disease, Inflammatory Lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 24 Apr 2026 (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.
Peripheral giant cell granuloma (PGCG) is a non-neoplastic inflammatory lesion of gingival tissues. This study aims to evaluate and compare lymphocyte subpopulations in PGCG tissues and adjacent healthy gingival tissues obtained from the same individuals.
A total of 28 systemically healthy, non-smoking patients diagnosed with PGCG are included in this study. Biopsy samples are collected during surgical excision of PGCG lesions, and corresponding healthy gingival tissues are obtained from the same patients.
Immunohistochemical analysis is performed to assess lymphocyte subpopulations, including CD3, CD4, CD8, CD20, and CD79a. The proportions of these cells are compared between diseased and healthy tissues.
Detailed description
Peripheral giant cell granuloma (PGCG) is a relatively common non-neoplastic inflammatory lesion of the gingiva characterized by multinucleated giant cells within a vascularized stroma. Lymphocyte subpopulations, including T- and B-cells, play a significant role in the immunopathogenesis of gingival and periodontal diseases.
The evaluation of lymphocyte subpopulations in gingival tissues is an established method for understanding local immune responses. However, limited data are available regarding lymphocyte profiles in PGCG lesions. Therefore, this study aims to investigate and compare lymphocyte subpopulations in PGCG and healthy gingival tissues.
This study is designed as a within-subject controlled observational study including 28 systemically healthy and non-smoking patients diagnosed with PGCG. Biopsy samples are obtained from PGCG lesions during surgical excision, and corresponding healthy gingival tissues are collected from the same individuals.
Tissue specimens are processed using standard histological procedures and analyzed by immunohistochemical methods. The presence and proportion of CD3, CD4, CD8, CD20, and CD79a positive cells are evaluated. The proportion of positively stained cells is calculated as the percentage of positive cells relative to the total number of counted cells.
The results are compared between PGCG tissues and healthy gingival tissues to identify differences in lymphocyte subpopulations and to better understand the immunopathological characteristics of PGCG.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PGCG Tissue | – | Diagnostic Test: Immunohistochemical AnalysisBiopsy samples obtained from peripheral giant cell granuloma lesions during surgical excision. |
| Healthy Gingival Tissue | – | Diagnostic Test: Immunohistochemical AnalysisBiopsy samples obtained from adjacent healthy gingival tissues of the same patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of 28 systemically healthy, non-smoking patients diagnosed with peripheral giant cell granuloma (PGCG).
Key inclusion criteria (5 listed)
- Systemically healthy individuals
- Non-smokers
- Patients diagnosed with peripheral giant cell granuloma
- Individuals requiring surgical excision of PGCG
- Patients providing written informed consent
Key exclusion criteria (5 listed)
- Presence of systemic diseases
- Smoking habit
- Use of medications associated with gingival enlargement
- History of periodontal treatment within the last 6 months
- Pregnant or lactating individuals
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 |
|---|---|---|
| Immunohistochemical AnalysisImmunohistochemical staining is performed on gingival tissue samples to evaluate lymphocyte subpopulations, including CD3, CD4, CD8, CD20, and CD79a. The proportion of positively stained cells is determined by calculating the percentage of positive cells relative to the total number of counted cells. | Diagnostic test | Healthy Gingival Tissue, PGCG Tissue |
Primary outcome
Proportion of Lymphocyte Subpopulations
Time frame: At the time of tissue analysis (baseline)
The proportion of CD3, CD4, CD8, CD20, and CD79a positive cells is determined by calculating the percentage of positively stained cells relative to the total number of counted cells in gingival tissue samples.
1 secondary outcome
CD4/CD8 Ratio
Time frame: At the time of tissue analysis (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 18 May 2026.
- Results publicationDilsiz A, Gürsan N, Aydın T. Immunohistochemical analysis of lymphocyte subpopulation in normal gingiva and peripheral giant cell granuloma. Journal of Clinical Periodontology. 2012;39(Suppl 13):97.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns and the sensitive nature of patient-derived tissue samples. The dataset is limited in size and contains potentially identifiable information.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Peripheral Giant Cell Granuloma and Gingival Lesions, run by Ataturk University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 18 May 2026. 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 Turkey (Türkiye). 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?
Proportion of Lymphocyte Subpopulations (time frame: At the time of tissue analysis (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07551310, which also lists 1 linked publication.
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 18 May 2026.