Free Soft Tissue Graft in Treatment of Oral Lichen Planus

NCT00737854 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2008-12-11

No results posted yet for this study

Summary

Oral lichen planus is a common chronic mucocutaneous disease with various clinical forms. Erosive-ulcerative forms usually cause symptoms of pain and discomfort. The most important complication of OLP is development of oral squamous cell carcinoma, although this is a very controversial matter. various treatments have been suggested for OLP but their results are unsatisfactory. Through the experiences of the investigators, corticosteroids (in any form)is not a wise option for treating OLP and has many side effects . More over, immunosuppressive therapy did not influence the risk for oral cancer. The purpose of the study is to determine the efficacy of free soft tissue graft in the treatment of precancerous and symptomatic lesions of OLP. Removal of the lesions up to submucosa has been done. The graft sliced from healthy mucosa also up to submucosa. Then graft will be sutured in position.

According to other authors, basal epithelial layers of the graft remain intact and represent the focus of re-epithelization. New epithelial cells migrate over the basal membrane and appear to guide it by proliferation, will generate new epithelium. The wound is re-epithelialized by proliferation of surrounding healthy epithelial cell, therefore, not contaminated by modified antigens of the cell membrane that are theoretically responsible for lymphocyte aggression. The healthy graft remains free of lesions and appears clinically healthy.

Conditions

  • Oral Lichen Planus

Interventions

PROCEDURE

Surgical resection

20 patients with OLP will be selected for this study. Before this routine treatment modalities had been attempted. Removal of possible triggering drug was also considered. Local ethical committee approval will be obtained before the trial starts. Surgical procedure includes: removal of the tissue up to submucosa (containing antigenic properties that caused OLP). A specimen will be sent for histopathologic analysis. The graft sliced from healthy mucosa also up to submucosa. Then the graft trimmed on a gauze soaked in saline and adapted to recipient site. The graft was sutured in position. Checking will be done after 1 week and every two months up to 1 year. Punch biopsy will be done in 1 year after surgery for histopathologic investigations.

Sponsors & Collaborators

  • Qazvin University Of Medical Sciences

    lead OTHER

Principal Investigators

  • Farshid Rayati, DDS · Qazvin University Of Medical Sciences

  • Tuba(Aida) Karagah, DDS · QUMS

  • Farshid Rayati, DDS · QUMS

  • Saeid Asefzadeh, PHD · QUMS

  • Poopak masumi, DDS-MS · QUMS

  • pourya falah, student · QUMS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-05-31
Completion
2010-12-31

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00737854 on ClinicalTrials.gov