Free Soft Tissue Graft in Treatment of Oral Lichen Planus

NCT00737854 | Unknown Phase 1 DMC

• 1 other identifier: ACTG022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Lichen Planus

Keywords

OLP; Free Soft Tissue Graft; Treatment

Outcome Measures

Primary Outcomes (1)

• Relief of sign & symptoms (every 2 month up to 1 years)

  1 year

Secondary Outcomes (1)

• Relief of sign & symptoms and no positive histopathologic features of OLP

  (time frame 1 years)

Study Arms (1)

1 ARM

EXPERIMENTAL

Otherwise healthy patients with oral lichen planus (precancerous/erosive OLP)

Procedure: Surgical resection

Interventions

Surgical resection PROCEDURE

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.

Also known as: surgical resection of OLP

1 ARM

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qazvin University Of Medical Sciences: lead

Study Sites (1)

Qazvin University of Medical Sciences

Qazvin, Qazvin State, 3415759811, Iran

RECRUITING

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

• Farshid Rayati, DDS

  Qazvin University Of Medical Sciences

  STUDY DIRECTOR

• Tuba(Aida) Karagah, DDS

  QUMS

  PRINCIPAL INVESTIGATOR

• Farshid Rayati, DDS

  QUMS

  STUDY CHAIR

• Saeid Asefzadeh, PHD

  QUMS

  STUDY CHAIR

• Poopak masumi, DDS-MS

  QUMS

  STUDY DIRECTOR

• pourya falah, student

  QUMS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farshid - Rayati, DDS

CONTACT

farshidrayati@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 18, 2008
• First Posted: August 20, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 11, 2008

Record last verified: 2008-08

Locations

IR (1)