Skip to main content
OpenTrials
Completed

NCT Number: NCT07551310

Lymphocyte Subpopulations in Peripheral Giant Cell Granuloma

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ataturk University Faculty of Dentistry

Erzurum, Malatya, 5444155691, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunohistochemical analysis

Diagnostic 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Immunohistochemical Evaluation of Lymphocyte Subpopulations in Peripheral Giant Cell Granuloma and Healthy Gingival Tissues: A Within-Subject Controlled Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.