Evaluation of Desmoglein-3 Autoantibodies in the Tissues of Oral Lichen Planus and Correlation with Disease Severity

NCT06652477 | Not Yet Recruiting

• 1 other identifier: Dsg3 in oral lichen planus
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.evaluate the level of Dsg3 autoantibodies in tissue biopsy of Atrophic/Bullous Erosive (A/BE) OLP (Primary Objective).
2. 2.correlate the severity of the disease with the level of tissue Dsg3 autoantibodies (Secondary Objective).

Conditions

Lichen Planus, Oral

Outcome Measures

Primary Outcomes (1)

• evaluate the level of Dsg3 autoantibodies in tissue biopsy of Atrophic/Bullous Erosive oral lichen planus

  valuate the level of Dsg3 autoantibodies by ELISA kit trying to elucidate the actual role of Dsg3 autoantibodies in the etiopathogenesis of OLP.

  baseline

Secondary Outcomes (1)

• correlate the severity of the disease with the level of tissue Dsg3 autoantibodies

  baseline

Study Arms (2)

groupe A

patients with atrophic boullos erosive oral lichen planus

Diagnostic Test: ELISA

groupe B

healthy patients

Diagnostic Test: ELISA

Interventions

ELISA DIAGNOSTIC_TEST

ElISA kit to detect autoantibodies against desmoglein 3 in tissues of oral lichen planus lesions

groupe A; groupe B

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study is designed to be a case-control study with a convenience sample size of (20) Participants, will be recruited from the Out-patient Clinic of Oral Medicine, Periodontology and Oral Diagnosis Department, Faculty of Dentistry Ain-Shams University or referred to it. The participants who will meet the eligibility criteria will be enrolled into one of the following groups • Group A: (10) participants suffering from oral lichen planus (atrophic bullous erosive pattern). • Group B: (10) healthy control participants. Tissue samples from the control group will be obtained from excess tissue from periodontal surgeries, mainly crown lengthening surgeries and implant placement surgeries (avoiding any periodontally affected teeth)

You may qualify if:

• \. Males or females suffering from A/BE OLP. 2. Proven diagnosis of oral lichen planus based on criteria of WHO (World Health Organization) which is a clinical criteria, clinically proven painful A/BE form of OLP confirmed by the presence of red or erythematous changes, or shallow ulcerations with fine lacy lines at the periphery of the lesion accentuated by stretching and not eliminated by rubbing (Wickham's striae).
• Histopathologically, proven Bullous/erosive or reticular forms of OLP confirmed by the presence of accepted histopathological criteria for lichen planus; basal cell liquefaction, band-like lymphocytic infiltrate at the epithelial-stromal junction with degeneration of basal cell region.

You may not qualify if:

• \. History of drug-induced lichenoid lesions. 2. Presence of systemic conditions such as serious active or recurrent infections, malignancy, diabetes mellitus, hypertension, or significant heart, liver, or renal diseases.
• \. Pregnancy or breastfeeding. 4. History of previous treatments potentially effective on OLP such as antimalarial agents, retinoids, corticosteroids, or immunosuppressive drugs from less than 2 weeks for topical medications, and 4 weeks for systemic medications prior to starting the study.
• \. Loss of pliability or flexibility in the tissues involved by the oral lesions of lichen planus.
• \. Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites.
• \. Patient refuses to participate in the study. 8. Vulnerable groups (handicapped, orphans, and prisoners).

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (4)

• Roopashree MR, Gondhalekar RV, Shashikanth MC, George J, Thippeswamy SH, Shukla A. Pathogenesis of oral lichen planus--a review. J Oral Pathol Med. 2010 Nov;39(10):729-34. doi: 10.1111/j.1600-0714.2010.00946.x. Epub 2010 Oct 4.

  PMID: 20923445 BACKGROUND

• Vahide L, Zahra H, Forugh G, Nazi S. Autoantibodies to desmogleins 1 and 3 in patients with lichen planus. Arch Dermatol Res. 2017 Sep;309(7):579-583. doi: 10.1007/s00403-017-1756-x. Epub 2017 Jul 3.

  PMID: 28674915 BACKGROUND

• Lukac J, Brozovic S, Vucicevic-Boras V, Mravak-Stipetic M, Malenica B, Kusic Z. Serum autoantibodies to desmogleins 1 and 3 in patients with oral lichen planus. Croat Med J. 2006 Feb;47(1):53-8.

  PMID: 16489697 BACKGROUND

• Abdelwadood D, Fouad YA, El-Khazragy N, Amr AEH. Desmoglein-3 autoantibodies in tissues of oral lichen planus patients and its correlation with disease severity: case-control study. BMC Oral Health. 2025 Jun 6;25(1):930. doi: 10.1186/s12903-025-06303-9.

  PMID: 40481453 DERIVED

MeSH Terms

Conditions

Lichen Planus, Oral

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ahmed Amr

  ain shamsh university

  PRINCIPAL INVESTIGATOR

• yasmeen foaad

  ain shamsh university

  STUDY DIRECTOR

Central Study Contacts

Doaa Abd Elwadood Mohamed, master's degree student

CONTACT

01118066148; Dr.doaa55@gmail.com

doaa abdElwadood Mohamed

CONTACT

01119220036; doaaabdelwadood55@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's degree student, Faculty of Dentistry, Ain Shams University.

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 22, 2024
• Study Start: November 5, 2024
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share