Gum health and disease severity in pemphigus vulgaris patients
Clinical Investigation of the Relationship Between Disease Severity and Periodontal Status in Patients With Pemphigus Vulgaris
This will see if pemphigus vulgaris severity in adults is linked to gum disease by comparing oral lesion scores and desmoglein blood levels with dental exam measurements.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Saglik Bilimleri Universitesi Academic / other |
| Locations | 1 site (Ankara) |
| Trial ID | NCT07384221 on ClinicalTrials.gov |
What this trial studies
This is an observational, cross-sectional study of adults with clinically and histopathologically confirmed pemphigus vulgaris who have at least 10 natural teeth. Researchers will score oral disease activity using the Oral Disease Severity Score (ODSS), draw blood to measure serum desmoglein 1 and 3 levels, and perform a full periodontal exam recording pocket depths and clinical attachment levels. Clinical and biochemical measures will be compared to determine relationships between pemphigus activity and periodontal status. Participants with recent antibiotic use, recent periodontal treatment, or who are pregnant or lactating will be excluded to avoid confounding factors.
Who should consider this trial
Good fit: Adults (18+) with a confirmed diagnosis of pemphigus vulgaris, at least 10 natural teeth, who can give informed consent and attend in-person dental and blood-draw visits are ideal candidates.
Not a fit: People without pemphigus vulgaris, those with fewer than 10 natural teeth, or those recently on antibiotics or who recently had periodontal treatment or who are pregnant/lactating are unlikely to benefit from joining this study.
Why it matters
Potential benefit: If a clear link is found, results could help clinicians identify patients at higher risk for periodontal problems and prompt earlier dental monitoring or treatment.
How similar studies have performed: Previous reports have documented oral involvement in pemphigus vulgaris but few studies have directly correlated desmoglein serum levels with detailed periodontal measurements, so this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ankara
- University of Health Sciences, Gulhane Faculty of Dentistry, Department of Periodontology — Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Nuriye Işıl Saygun, Professor — University of Health Sciences, Gulhane Faculty of Dentistry, Department of Periodontology
- Study coordinator: Bilkan KARA, Dr.
- Email: bilkankara@gmail.com
- Phone: +905383781679
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.