Oral Lichen PlanusNCT06033105
Vitamin D Deficiency As a Risk Factor for the Development and Malignant Transformation of Oral Lichen Planus
An observational study of Oral Lichen Planus and Vitamin D Deficiency, run by Fayoum University at 1 site in Egypt.
Trial summary
To examine how a lack of vitamin D may increase the risk of developing oral lichen planus and its malignant progression while accounting for sex, food habits, sunlight, socioeconomic level, and psychological variables. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oral Lichen Planus, Vitamin D Deficiency
- What is being tested?
- ELISA
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 24 Aug 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients presenting with a clinical picture and histological findings that confirm the diagnosis of OLP (Group A) and age, sex, and dietary habits matched healthy controls (Group B).
Who may be able to join
- (Group A) patients presenting with a clinical picture and histological findings that confirm the diagnosis of OLP
- (Group B) age, sex, and dietary habits matched healthy controls.
Who cannot join
- (1) subjects who have been receiving any kind of VD supplements, multivitamins, or any drug that may affect VD measurements
- (2) patients with suspected restoration-related or smokeless tobacco-related lesions.
- (3) patients with any systemic medical condition or pregnant females.
- (4) patients with VD toxicity (VD≥100 ng/ml).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D Deficiency As a Risk Factor for the Development and Malignant Transformation of Oral Lichen Planus: a Case-control Study
To examine how a lack of vitamin D may increase the risk of developing oral lichen planus and its malignant progression while accounting for sex, food habits, sunlight, socioeconomic level, and psychological variables.
- Conditions
- Oral Lichen Planus, Vitamin D Deficiency
- Being tested
- ELISA
- Medical subject headings
- Lichen Planus, Oral, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISADevice
Enzyme-linked immunosorbent assay (ELISA) was used following manufacturer's instructions. This test uses a competitive ELISA-based technique that was designed to quantitatively determine the concentration of 1,25-dihydroxyvitamin D3/D2 in human serum.
| Study group | Role | What they receive |
|---|---|---|
| Group A | 35 OLP patients Receives: Device: ELISA | |
| Group B | 35 healthy controls. Receives: Device: ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum vitamin D level in OLP
measured by ELISA
Measured: 1 month
Secondary outcomes (3)
serum vitamin D level in correlation with sex, dietary habits and sun exposure.
Questionnaire, measured in proportions
Measured: 1 month
serum vitamin D level in correlation with socioeconomic status
Kuppuswamy's socioeconomic status scale
Measured: 1 month
serum vitamin D level in correlation with Psychological factors
Depression Anxiety and Stress Scale 21 (DASS-21)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Aug 2023
- Primary completion24 Aug 2023
- Study completion24 Aug 2023
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salsabeel A Afifi, PhD, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033105
- Sponsor's protocol ID
- 2191982
- Status last verified
- Sep 2023
- First submitted
- 2 Sep 2023
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon Request
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Deficiency As a Risk Factor for the Development and Malignant Transformation of Oral Lichen Planus: a Case-control Study
- ClinicalTrials.gov ID
- NCT06033105
- Acronym / sponsor ID
- 2191982
- Conditions
- Oral Lichen Planus, Vitamin D Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 13 Sep 2023 (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.
To examine how a lack of vitamin D may increase the risk of developing oral lichen planus and its malignant progression while accounting for sex, food habits, sunlight, socioeconomic level, and psychological variables.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: ELISA35 OLP patients |
| Group B | – | Device: ELISA35 healthy controls. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients presenting with a clinical picture and histological findings that confirm the diagnosis of OLP (Group A) and age, sex, and dietary habits matched healthy controls (Group B).
Key inclusion criteria (2 listed)
- (Group A) patients presenting with a clinical picture and histological findings that confirm the diagnosis of OLP
- (Group B) age, sex, and dietary habits matched healthy controls.
Key exclusion criteria (4 listed)
- (1) subjects who have been receiving any kind of VD supplements, multivitamins, or any drug that may affect VD measurements
- (2) patients with suspected restoration-related or smokeless tobacco-related lesions.
- (3) patients with any systemic medical condition or pregnant females.
- (4) patients with VD toxicity (VD≥100 ng/ml).
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 |
|---|---|---|
| ELISAEnzyme-linked immunosorbent assay (ELISA) was used following manufacturer's instructions. This test uses a competitive ELISA-based technique that was designed to quantitatively determine the concentration of 1,25-dihydroxyvitamin D3/D2 in human serum. | Device | Group A, Group B |
Primary outcome
serum vitamin D level in OLP
Time frame: 1 month
measured by ELISA
3 secondary outcomes
serum vitamin D level in correlation with sex, dietary habits and sun exposure.
Time frame: 1 month
serum vitamin D level in correlation with socioeconomic status
Time frame: 1 month
serum vitamin D level in correlation with Psychological factors
Time frame: 1 month
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 20 Nov 2024.
- Individual participant dataSharing planned: Undecided. Upon Request
Related trials for 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Vitamin D Deficiency, run by Fayoum University at 1 site in Egypt.
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 2 inclusion and 4 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 20 Nov 2024. 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 Egypt. 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?
serum vitamin D level in OLP (time frame: 1 month). 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 20 Nov 2024.