Lymphocyte Subpopulations in Peripheral Giant Cell Granuloma

May 14, 2026 updated by: Alparslan Dilsiz, Ataturk University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Malatya
      • Erzurum, Malatya, Turkey (Türkiye), 5444155691
        • Ataturk University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of 28 systemically healthy, non-smoking patients diagnosed with peripheral giant cell granuloma (PGCG).

Description

Inclusion Criteria:

  • Systemically healthy individuals
  • Non-smokers
  • Patients diagnosed with peripheral giant cell granuloma
  • Individuals requiring surgical excision of PGCG
  • Patients providing written informed consent

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PGCG Tissue
Biopsy samples obtained from peripheral giant cell granuloma lesions during surgical excision.
Diagnostic test: Immunohistochemical Analysis
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.
Healthy Gingival Tissue
Biopsy samples obtained from adjacent healthy gingival tissues of the same patients.
Diagnostic test: Immunohistochemical Analysis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the time of tissue analysis (baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD4/CD8 Ratio
Time Frame: At the time of tissue analysis (baseline)
The ratio of CD4 positive cells to CD8 positive cells is calculated to evaluate differences in lymphocyte subpopulations.
At the time of tissue analysis (baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Actual)

March 1, 2026

Study Completion (Actual)

March 30, 2026

Study Registration Dates

First Submitted

April 18, 2026

First Submitted That Met QC Criteria

April 18, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATAUNI-PGCG-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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