Periodontal Status and Disease Severity in Pemphigus Vulgaris Patients

January 26, 2026 updated by: NURIYE ISIL SAYGUN, Saglik Bilimleri Universitesi

Clinical Investigation of the Relationship Between Disease Severity and Periodontal Status in Patients With Pemphigus Vulgaris

The aim of this study is to evaluate the relationship between the severity of Pemphigus Vulgaris (a chronic autoimmune skin disease) and periodontal (gum) health. Researchers will assess disease activity using the Oral Disease Severity Score (ODSS) for mouth lesions and measure serum Desmoglein 1 and 3 levels through blood tests. These findings will be compared with clinical gum measurements, such as pocket depth and attachment levels. The study intends to determine how the clinical and biochemical severity of Pemphigus Vulgaris impacts periodontal tissues and overall oral health.

Study Overview

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

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

Study Contact

Study Locations

      • Ankara, Turkey (Türkiye), 06010
        • Recruiting
        • University of Health Sciences, Gulhane Faculty of Dentistry, Department of Periodontology
        • Contact:
        • Principal Investigator:
          • Nuriye Işıl SAYGUN, Professor

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 adult patients diagnosed with Pemphigus Vulgaris who are receiving treatment or follow-up at the dermatology clinic.

Description

Inclusion Criteria:

  • Patients aged 18 years and older.
  • Clinically and histopathologically confirmed diagnosis of Pemphigus Vulgaris.
  • Presence of at least 10 natural teeth.
  • Willingness to participate and signed informed consent.

Exclusion Criteria:

  • Pregnancy or lactation.
  • Use of systemic antibiotics or anti-inflammatory drugs within the last 3 months.
  • Periodontal treatment received within the last 6 months.

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
Pemphigus Vulgaris Group
A comprehensive oral examination including ODSS scoring and periodontal measurements (PPD, CAL, PI, GI). Additionally, serum Desmoglein 1 and 3 levels will be retrieved from the patients' medical records for biochemical correlation.
"Participants will undergo a comprehensive oral examination. The severity of oral mucosal involvement will be recorded using the Oral Disease Severity Score (ODSS). Clinical periodontal parameters, including Probing Pocket Depth (PPD) and Clinical Attachment Level (CAL), will be measured at six sites per tooth using a periodontal probe. Additionally, current serum Desmoglein 1 and 3 levels will be retrieved from the patients' medical records for clinical correlation."

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Disease Severity Score (ODSS)
Time Frame: Baseline
A clinical scoring system used to assess the severity of oral mucosal involvement in patients with Pemphigus Vulgaris. It evaluates the site and extent of lesions in the oral cavity.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Desmoglein 1 and 3 Levels
Time Frame: Baseline
Anti-desmoglein 1 and anti-desmoglein 3 autoantibody titers as recorded in the patients' medical laboratory results. Values are measured in Relative Units per milliliter (RU/mL).
Baseline
Clinical Attachment Level (CAL)
Time Frame: Baseline
Measurement of the distance from the cemento-enamel junction to the base of the periodontal pocket in millimeters. Higher values indicate greater attachment loss.
Baseline
Probing Pocket Depth (PPD)
Time Frame: Baseline
Measurement of the distance from the gingival margin to the base of the periodontal pocket in millimeters using a periodontal probe.
Baseline
Plaque Index (PI)
Time Frame: Baseline
An index used to assess the thickness of plaque at the gingival margin. It evaluates oral hygiene status on a scale from 0 to 3 for each tooth surface, measured according to the criteria of Silness and Löe.
Baseline
Gingival Index (GI)
Time Frame: Baseline
A clinical index used to assess the severity of gingival inflammation and bleeding tendency. It evaluates the color, consistency, and bleeding of the gums on a scale from 0 to 3, measured according to the criteria of Silness and Löe.
Baseline

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Nuriye Işıl Saygun, Professor, University of Health Sciences, Gulhane Faculty of Dentistry, Department of Periodontology

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)

November 1, 2025

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

February 21, 2026

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To protect participant privacy and maintain confidentiality, there are no plans to share individual participant data.

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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