NCT07551310

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 18, 2026

Last Update Submit

April 18, 2026

Conditions

Keywords

Lymphocyte SubpopulationsImmunohistochemistryGingival TissueOral PathologyPeriodontal DiseaseInflammatory Lesions

Outcome Measures

Primary Outcomes (1)

  • 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.

    At the time of tissue analysis (baseline)

Secondary Outcomes (1)

  • CD4/CD8 Ratio

    At the time of tissue analysis (baseline)

Study Arms (2)

PGCG Tissue

Biopsy samples obtained from peripheral giant cell granuloma lesions during surgical excision.

Diagnostic Test: Immunohistochemical Analysis

Healthy Gingival Tissue

Biopsy samples obtained from adjacent healthy gingival tissues of the same patients.

Diagnostic Test: Immunohistochemical Analysis

Interventions

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 TissuePGCG Tissue

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Faculty of Dentistry

Erzurum, Malatya, 5444155691, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    RESULT

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival tissue biopsy samples obtained from peripheral giant cell granuloma lesions and adjacent healthy gingival tissues are retained and used for immunohistochemical analysis.

MeSH Terms

Conditions

Granuloma, Giant CellGingival HyperplasiaPeriodontal Diseases

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesGingival DiseasesMouth DiseasesGranulomaPathologic ProcessesPathological Conditions, Signs and SymptomsGingival Overgrowth

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 18, 2026

First Posted

April 24, 2026

Study Start

January 1, 2026

Primary Completion

March 1, 2026

Study Completion

March 30, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations