University of Health Sciences, Gulhane Faculty of Dentistry, Department of Periodontology
Ankara, 06010, Turkey (Türkiye)
Location status: Recruiting
Location contact
Bilkan KARA, Dr.
CONTACT
Nuriye Işıl SAYGUN, Professor
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT07384221
Periodontal Status and Disease Severity in Pemphigus Vulgaris Patients
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Clinical Periodontal and Oral Evaluation
Other"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."
Primary outcomes
-
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.
Secondary outcomes
-
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).
-
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.
-
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.
-
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.
-
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Saglik Bilimleri Universitesi
Other
Registry information
Official study title
Clinical Investigation of the Relationship Between Disease Severity and Periodontal Status in Patients With Pemphigus Vulgaris
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Feb 3, 2026
- Registry last updated
- Feb 3, 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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Completed
Evaluating Legit.Health Plus Support for Improving Diagnosis of Generalized Pustular Psoriasis and Other Skin Conditions Among Primary Care Physicians and Dermatologists
NCT07428915
Acne, Acne Conglobata
Bilbao, Basque Country, Spain
View Trial Details
Not Yet Recruiting
Trichoscopy as a Monitoring Tool for Activity and Remission in Pemphigus Vulgaris: A Clinical Study Supported by Immunological Evaluation.
NCT06863454
Autoimmune Diseases, Immune System Diseases
View Trial Details
Not Yet Recruiting
A Randomized Study on Pemphigus Treatment With Humanized CD38 Antibody CM313.
NCT06663943
Autoimmune Diseases, Immune System Diseases
View Trial Details
Completed
Efficacy and Safety Evaluation of Anti-CD20 Monoclonal Antibody Combined with Azathioprine and Corticosteroids in the Treatment of Pemphigus Vulgaris
NCT06654817
Autoimmune Diseases, Immune System Diseases
Fuzhou, Fujian, China
View Trial Details