Oral Lichen PlanusNCT05403216
Relationship Between Oral Lichen Planus and Autoimmune Thyroid Diseases
An observational study of Oral Lichen Planus, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Lichen Planus
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 31 Dec 2024
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Oral lichen planus (OLP) patients
Who may be able to join
- OLP patients without systemic disease
Who cannot join
- OLP patients with severe periodontal disease
Trial locations and contacts
1 site in 1 country.
China1 site
The Stomatology Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310014
About this study
Official title: Clinical Value of the Relationship Between Oral Lichen Planus and Autoimmune Thyroid Diseases
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.
Read the 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.
- Conditions
- Oral Lichen Planus
- Being tested
- no intervention
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| OLP(-) | Oral lichen planus (OLP) with negative thyroid antibody group | |
| OLP(+) | OLP with positive thyroid antibody group Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral lichen planus (OLP) lesions record
Record changes of lesions based on the symptoms and signs of the oral lichen planus patient.
Measured: 1 year
Level of thyroid function and antibody
The levels of thyroid hormone and thyroid autoantibodies in serum of OLP patients were detected.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Dec 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Dental Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qianming Chen, The Dental Hospital of Zhejiang University School of Medicine
- Investigators
- Qianming Chen, Dr., Study chair, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403216
- Sponsor's protocol ID
- I20210609
- Status last verified
- Sep 2025
- First submitted
- 13 Mar 2022
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of the Relationship Between Oral Lichen Planus and Autoimmune Thyroid Diseases
- ClinicalTrials.gov ID
- NCT05403216
- Acronym / sponsor ID
- I20210609
- Conditions
- Oral Lichen Planus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Dental Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 3 Jun 2022 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OLP(-) | – | –Oral lichen planus (OLP) with negative thyroid antibody group |
| OLP(+) | – | Other: no interventionOLP with positive thyroid antibody group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Oral lichen planus (OLP) patients
Key inclusion criteria (1 listed)
- OLP patients without systemic disease
Key exclusion criteria (1 listed)
- OLP patients with severe periodontal disease
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 |
|---|---|---|
| no intervention | Other | OLP(+) |
Primary outcome
Oral lichen planus (OLP) lesions record
Time frame: 1 year
Record changes of lesions based on the symptoms and signs of the oral lichen planus patient.
Level of thyroid function and antibody
Time frame: 1 year
The levels of thyroid hormone and thyroid autoantibodies in serum of OLP patients were detected.
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 25 Sep 2025.
- Individual participant dataSharing planned: No
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Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
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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.
Qianming Chen, Dr. study chair
Zhejiang University
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 Oral Lichen Planus, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
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 1 inclusion and 1 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 25 Sep 2025. 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 China. 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 lichen planus (OLP) lesions record (time frame: 1 year). The study lists 2 primary outcomes in all. 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 25 Sep 2025.