Pemphigus Vulgaris (PV)NCT07384221
Periodontal Status and Disease Severity in Pemphigus Vulgaris Patients
An observational study of Pemphigus Vulgaris (PV) and Periodontal Diseases, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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, and to compare the findings with those of a systemically healthy control group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pemphigus Vulgaris (PV), Periodontal Diseases
- What is being tested?
- Clinical Periodontal and Oral Evaluation
- Type of treatment
- Pill or oral medicine
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 21 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of adult patients diagnosed with Pemphigus Vulgaris who are receiving treatment or follow-up at the dermatology clinic.
Who may be able to join
- Patients aged 18 years and older.
- Clinically and histopathologically confirmed diagnosis of pemphigus vulgaris (PV) (for the Pemphigus Vulgaris group).
- Presence of at least 10 natural teeth.
- Willingness to participate and signed informed consent.
Who cannot join
- Pregnancy or lactation.
- Use of systemic antibiotics or anti-inflammatory drugs within the last 3 months.
- Periodontal treatment received within the last 6 months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Gulhane Faculty of Dentistry, Department of Periodontology
Ankara, 06010
About this study
Official title: 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, and to compare the findings with those of a systemically healthy control group. Researchers will assess disease activity using the Oral Disease Severity Score (ODSS) for oral lesions and measure serum Desmoglein 1 and 3 levels through blood tests. These findings will be compared with clinical periodontal parameters, such as probing pocket depth and clinical attachment levels, in both groups. The study intends to determine how the clinical and biochemical severity of Pemphigus Vulgaris impacts periodontal tissues and overall oral health, as well as identify potential differences in periodontal status between patients with Pemphigus Vulgaris and systemically healthy individuals.
- Conditions
- Pemphigus Vulgaris (PV), Periodontal Diseases
- Being tested
- Clinical Periodontal and Oral Evaluation
- Keywords
- Pemphigus Vulgaris, Periodontitis, Desmoglein, ODSS (Oral Disease Severity Score)
- Medical subject headings
- Pemphigus, Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Periodontal and Oral EvaluationOther
"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."
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Clinical Periodontal and Oral Evaluation | |
| Systemically Healthy Control Group | Systemically healthy individuals without a diagnosis of Pemphigus Vulgaris will be included in the control group. Participants will undergo a clinical periodontal examination, including assessment of probing pocket depth, clinical attachment level, and other relevant periodontal parameters. The periodontal status of the control group will be compared with that of patients with Pemphigus Vulgaris to evaluate differences in periodontal health. No therapeutic intervention will be administered as part of the study. Receives: Other: Clinical Periodontal and Oral Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (5)
Serum Desmoglein 1 and 3 Levels
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).
Measured: Baseline
Clinical Attachment Level (CAL)
Measurement of the distance from the cemento-enamel junction to the base of the periodontal pocket in millimeters. Higher values indicate greater attachment loss.
Measured: Baseline
Probing Pocket Depth (PPD)
Measurement of the distance from the gingival margin to the base of the periodontal pocket in millimeters using a periodontal probe.
Measured: Baseline
Plaque Index (PI)
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.
Measured: Baseline
Gingival Index (GI)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Nov 2025
- Primary completion30 May 2026
- Study completion21 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pemphigus Vulgaris (PV)Studies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NURIYE ISIL SAYGUN, Saglik Bilimleri Universitesi
- Investigators
- Nuriye Işıl Saygun, Professor, Principal investigator, University of Health Sciences, Gulhane Faculty of Dentistry, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384221
- Sponsor's protocol ID
- 2026-199
- Status last verified
- Oct 2026
- First submitted
- 26 Jan 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect participant privacy and maintain confidentiality, there are no plans to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Relationship Between Disease Severity and Periodontal Status in Patients With Pemphigus Vulgaris
- ClinicalTrials.gov ID
- NCT07384221
- Acronym / sponsor ID
- 2026-199
- Conditions
- Pemphigus Vulgaris (PV), Periodontal Diseases
- Keywords
- Pemphigus Vulgaris, Periodontitis, Desmoglein, ODSS (Oral Disease Severity Score)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, and to compare the findings with those of a systemically healthy control group. Researchers will assess disease activity using the Oral Disease Severity Score (ODSS) for oral lesions and measure serum Desmoglein 1 and 3 levels through blood tests. These findings will be compared with clinical periodontal parameters, such as probing pocket depth and clinical attachment levels, in both groups. The study intends to determine how the clinical and biochemical severity of Pemphigus Vulgaris impacts periodontal tissues and overall oral health, as well as identify potential differences in periodontal status between patients with Pemphigus Vulgaris and systemically healthy individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pemphigus Vulgaris Group | – | Other: Clinical Periodontal and Oral EvaluationA 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. |
| Systemically Healthy Control Group | – | Other: Clinical Periodontal and Oral EvaluationSystemically healthy individuals without a diagnosis of Pemphigus Vulgaris will be included in the control group. Participants will undergo a clinical periodontal examination, including assessment of probing pocket depth, clinical attachment level, and other relevant periodontal parameters. The periodontal status of the control group will be compared with that of patients with Pemphigus Vulgaris to evaluate differences in periodontal health. No therapeutic intervention will be administered as part of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients diagnosed with Pemphigus Vulgaris who are receiving treatment or follow-up at the dermatology clinic.
Key inclusion criteria (4 listed)
- Patients aged 18 years and older.
- Clinically and histopathologically confirmed diagnosis of pemphigus vulgaris (PV) (for the Pemphigus Vulgaris group).
- Presence of at least 10 natural teeth.
- Willingness to participate and signed informed consent.
Key exclusion criteria (3 listed)
- Pregnancy or lactation.
- Use of systemic antibiotics or anti-inflammatory drugs within the last 3 months.
- Periodontal treatment received within the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Periodontal and Oral Evaluation"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." | Other | Pemphigus Vulgaris Group, Systemically Healthy Control Group |
Primary outcome
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.
5 secondary outcomes
Serum Desmoglein 1 and 3 Levels
Time frame: Baseline
Clinical Attachment Level (CAL)
Time frame: Baseline
Probing Pocket Depth (PPD)
Time frame: Baseline
Plaque Index (PI)
Time frame: Baseline
Gingival Index (GI)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No. To protect participant privacy and maintain confidentiality, there are no plans to share individual participant data.
Related trials for Pemphigus Vulgaris (PV)
RecruitingPhase 1/2
A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV)
Pemphigus Vulgaris
Not yet recruitingObservational study
Trichoscopy as a Monitoring Tool for Activity and Remission in Pemphigus Vulgaris: A Clinical Study Supported by Immunological Evaluation.
Pemphigus Vulgaris (PV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuriye Işıl Saygun, Professor principal investigator
University of Health Sciences, Gulhane Faculty of Dentistry, Department of Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pemphigus Vulgaris (PV) and Periodontal Diseases, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Disease Severity Score (ODSS) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.