Clinical trial NCT00737854: Free Soft Tissue Graft in Treatment of Oral Lichen Planus
Official title: Free Soft Tissue Graft in Treatment of Oral Lichen Planus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Oral Lichen Planus
Keywords: OLP
Free Soft Tissue Graft
Treatment
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2008-08-20
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Biopsy confirmed symptomatic oral lichen planus: WHO histological criteria in combination with clinical appearance will be used for diagnosis
* Previous routine treatment modalities has been attempted including steroids and immunomodulatory or antioxidant agents. i.e patients who had resistant lesions to routine treatment .removal of possible triggering drugs was also considered.
* Patients of both sexes between 40 to 70 year's old
* Patients who have symptoms such as burning sensation, pain
* Patients who have localized precancerous lesions such as atrophic-erosive/plaque like lichen planus with diameter lesser than 2 cm
* Patients who agree to this treatment
* Patients who are willing for evaluation in first week after surgery and every two month for 1 years
* Patients who agree to final punch biopsy for histopathologic evaluation

Exclusion criteria:

* Patients who unable to undergo oral surgery
* Patients suffering from any localized or systemic disease
* Pregnant patients
* Smokers
* Patients who can not continue the study for private or social reasons
* Patients with generalized oral lichen planus

Primary outcomes:
measure: Relief of sign & symptoms (every 2 month up to 1 years)
timeFrame: 1 year
Secondary outcomes:
measure: Relief of sign & symptoms and no positive histopathologic features of OLP
timeFrame: (time frame 1 years)
Other outcomes:
Locations:
city: Qazvin
country: Iran, Islamic Republic of
facility: Qazvin University of Medical Sciences
state: Qazvin State
Study officials:
affiliation: Qazvin University Of Medical Sciences
name: Farshid Rayati, DDS
role: STUDY_DIRECTOR
affiliation: QUMS
name: Tuba(Aida) Karagah, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: QUMS
name: Farshid Rayati, DDS
role: STUDY_CHAIR
affiliation: QUMS
name: Saeid Asefzadeh, PHD
role: STUDY_CHAIR
affiliation: QUMS
name: Poopak masumi, DDS-MS
role: STUDY_DIRECTOR
affiliation: QUMS
name: pourya falah, student
role: PRINCIPAL_INVESTIGATOR
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