NCT07384221

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2026

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2026

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 26, 2026

Last Update Submit

January 26, 2026

Conditions

Keywords

Pemphigus VulgarisPeriodontitisDesmogleinODSS (Oral Disease Severity Score)

Outcome Measures

Primary Outcomes (1)

  • Oral Disease Severity Score (ODSS)

    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 Outcomes (5)

  • Serum Desmoglein 1 and 3 Levels

    Baseline

  • Clinical Attachment Level (CAL)

    Baseline

  • Probing Pocket Depth (PPD)

    Baseline

  • Plaque Index (PI)

    Baseline

  • Gingival Index (GI)

    Baseline

Study Arms (1)

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.

Other: Clinical Periodontal and Oral Evaluation

Interventions

"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."

Pemphigus Vulgaris Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Gulhane Faculty of Dentistry, Department of Periodontology

Ankara, 06010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

PemphigusPeriodontal DiseasesPeriodontitis

Interventions

Diagnosis, Oral

Condition Hierarchy (Ancestors)

Skin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

  • Nuriye Işıl Saygun, Professor

    University of Health Sciences, Gulhane Faculty of Dentistry, Department of Periodontology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bilkan KARA, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Periodontology

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 3, 2026

Study Start

November 1, 2025

Primary Completion

January 30, 2026

Study Completion

February 21, 2026

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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

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