Relationship Between Oral Lichen Planus and Autoimmune Th... | NCT05403216

Studies
Relationship Between Oral Lichen Planus and Autoimmune Thyroid Diseases

NCT05403216

Sponsor

The Dental Hospital of Zhejiang University School of Medicine

Status

Completed

Last Update Posted

Sep 25, 2025Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Oral Lichen Planus

Interventions

no intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2022Actual

Primary Completion Date

Dec 31, 2024Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

Mar 13, 2022

First Submission Date that Met QC Criteria

May 30, 2022

First Posted Date

Jun 3, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2025

Last Update Posted Date

Sep 25, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Qianming Chen, professor, The Dental Hospital of Zhejiang University School of MedicinePrincipal Investigator

Lead Sponsor

The Dental Hospital of Zhejiang University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

On the basis of previous studies, a validation cohort will be established to explore the relationship between oral lichen planus and autoimmune thyroid diseases, and a disease efficacy prediction strategy can be formed.

Detailed Description

For oral lichen planus patients, the prevalence of Hashimoto's thyroiditis will be investigated and the relationship between levels of anti-TG, anti-TPO antibodies and severity of oral lichen planus will be determined.

Besides, for patients with Hashimoto's thyroiditis, the prevalence of oral lichen planus will be investigated and the relationship between levels of anti-TG, anti-TPO antibodies and severity of oral lichen planus will be determined.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OLP(-)		Oral lichen planus (OLP) with negative thyroid antibody group
OLP(+)		OLP with positive thyroid antibody group	Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other		OLP(+)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oral lichen planus (OLP) lesions record	Record changes of lesions based on the symptoms and signs of the oral lichen planus patient.	1 year
Level of thyroid function and antibody	The levels of thyroid hormone and thyroid autoantibodies in serum of OLP patients were detected.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

OLP patients without systemic disease

Exclusion Criteria:

OLP patients with severe periodontal disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Oral lichen planus (OLP) patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Qianming Chen, Dr.	Zhejiang University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Stomatology Hospital, Zhejiang University School of Medicine		Hangzhou	Zhejiang	310014	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017676	Lichen Planus, Oral

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D008010	Lichen Planus
D017512	Lichenoid Eruptions

Browse Leaves

Not provided

Browse Branches

Not provided