Free Soft Tissue Graft in Treatment of Oral Lichen Planus (TOLP)
Recruitment status was: Recruiting
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Free Soft Tissue Graft in Treatment of Oral Lichen Planus|
- Relief of sign & symptoms (every 2 month up to 1 years) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Relief of sign & symptoms and no positive histopathologic features of OLP [ Time Frame: (time frame 1 years) ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Experimental: 1 ARM
Otherwise healthy patients with oral lichen planus (precancerous/erosive OLP)
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.
Other Name: surgical resection of OLP
Oral lesions in OLP are chronic ,rarely undergo spontaneous remission, are potentially premalignant and are often a source of morbidity. recent study does not support that non reticular OLP are more predisposed to malignant change. Moreover , immunosuppressive therapy did not influence the risk for oral cancer. in general ,all treatment should be aimed at eliminating precancerous lesions ,alleviating symptoms ,and potentially decreasing the risk of malignant transformation. Although the cause of OLP is unknown , it is generally considered to be an immunologically mediated process that microscopically resembles a hypersensitivity reaction .it is characterized by an intense T cell infiltrate localized to epithelium-connective tissue interface. the purpose of the study is to determined the efficacy of free soft tissue graft in treatment of precancerous and symptomatic lesions of OLP. so removal of the lesions up to submucosa will be 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 reepithelialization. new epithelial cell migrate over the basal membrane and appear to guide it and by proliferation ,will generate new epithelium. so 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 so the healthy graft remains free of lesions and appears clinically healthy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737854
|Iran, Islamic Republic of|
|Qazvin University of Medical Sciences|
|Qazvin, Qazvin State, Iran, Islamic Republic of, 3415759811|
|Study Director:||Farshid Rayati, DDS||Qazvin University Of Medical Sciences|
|Principal Investigator:||Tuba(Aida) Karagah, DDS||QUMS|
|Study Chair:||Farshid Rayati, DDS||QUMS|
|Study Chair:||Saeid Asefzadeh, PHD||QUMS|
|Study Director:||Poopak masumi, DDS-MS||QUMS|
|Principal Investigator:||pourya falah, student||QUMS|