- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07384221
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
Status
Recruiting
Conditions
Intervention / Treatment
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
- Name: Bilkan KARA, Dr.
- Phone Number: +905383781679
- Email: bilkankara@gmail.com
Study Locations
-
-
-
Ankara, Turkey (Türkiye), 06010
- Recruiting
- University of Health Sciences, Gulhane Faculty of Dentistry, Department of Periodontology
-
Contact:
- Bilkan KARA, Dr.
- Phone Number: +905383781679
- Email: bilkankara@gmail.com
-
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-161
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.
Clinical Trials on Periodontal Diseases
-
Tel Aviv UniversityRecruitingPeriodontal Disease | Periodontal Attachment Loss | Periodontal PocketsIsrael
-
Riga Stradins UniversityUniversity of TurkuRecruitingPeriodontitis | Periodontal Diseases | Periodontal Bone Loss | Periodontal Disease | Periodontal Regeneration | Periodontal Healing | Periodontal Granulation Tissue | Vertical Periodontal Bone DefectsLatvia
-
Ohio State UniversityNot yet recruitingPeriodontal Disease | Periodontal SurgeryUnited States
-
G. d'Annunzio UniversityRecruitingPeriodontal Diseases | Intrabony Periodontal Defect | Periodontal Attachment Loss | Pocket, PeriodontalAlbania
-
University of Roma La SapienzaActive, not recruitingPeriodontal Disease | Periodontal Disease, AVDC Stage 3 | Periodontal Disease Stage 2Italy
-
Saglik Bilimleri UniversitesiRecruitingPeriodontitis | Periodontal Diseases | Periodontal Bone Loss | Intrabony Periodontal Defect | Periodontal DefectTurkey (Türkiye)
-
Siddharth ShanbhagUniversidad Complutense de MadridNot yet recruitingPeriodontal Disease | Intrabony Periodontal DefectsNorway, Spain
-
Kafrelsheikh UniversityActive, not recruitingPeriodontal Diseases | Periodontal Attachment LossEgypt
-
Krishnadevaraya College of Dental Sciences & HospitalCompletedPeriodontitis | Periodontal Attachment Loss | Periodontal Inflammation | Pocket, PeriodontalIndia
-
University of BeykentCompletedPeriodontal Diseases | Periodontal Attachment Loss | Periodontal Inflammation | Periodontal Disease, AVDC Stage 3 | Periodontal Disease, AVDC Stage 4Turkey
Clinical Trials on Clinical Periodontal and Oral Evaluation
-
Abant Izzet Baysal UniversityRecruitingPeriodontitis | Gingivitis and Periodontal DiseasesTurkey (Türkiye)
-
Necmettin Erbakan UniversityEnrolling by invitationPeriodontitis | GingivitisTurkey
-
University of Campinas, BrazilEnrolling by invitationPeriodontitis | Periodontal DiseasesBrazil
-
University of FlorenceCompleted
-
University of Sao Paulo General HospitalActive, not recruitingSjogren's SyndromeBrazil
-
Inonu UniversityCompletedPeri-implantitis | Peri-implant Mucositis | Dental ImplantsTurkey (Türkiye)
-
Dr. Mehmet Selim YildizCompletedDental Implantation | Peri-implant Mucositis | Orthodontic Anchorage Procedures | Gingival Inflammation and BleedingTurkey
-
Abant Izzet Baysal UniversityActive, not recruitingPeriodontal DiseaseTurkey (Türkiye)
-
Aydin Adnan Menderes UniversityCompleted
-
Shanghai Ninth People's Hospital Affiliated to...RecruitingPeriodontitis | GingivitisChina