Free Soft Tissue Graft in Treatment of Oral Lichen Planus (TOLP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Qazvin University Of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00737854
First received: August 18, 2008
Last updated: December 9, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Oral Lichen Planus
Procedure: Surgical resection
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Qazvin University Of Medical Sciences:

Primary Outcome Measures:
  • Relief of sign & symptoms (every 2 month up to 1 years) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Relief of sign & symptoms and no positive histopathologic features of OLP [ Time Frame: (time frame 1 years) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
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)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737854

Contacts
Contact: Farshid - Rayati, DDS farshidrayati@yahoo.com

Locations
Iran, Islamic Republic of
Qazvin University of Medical Sciences Recruiting
Qazvin, Qazvin State, Iran, Islamic Republic of, 3415759811
Contact: Farshid Rayati, DDS       farshidrayati@yahoo.com   
Sponsors and Collaborators
Qazvin University Of Medical Sciences
Investigators
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
  More Information

No publications provided

Responsible Party: Qazvin University Of Medical Sciences, Qazvin University Of Medical Sciences . Deputy of Research
ClinicalTrials.gov Identifier: NCT00737854     History of Changes
Other Study ID Numbers: ACTG022
Study First Received: August 18, 2008
Last Updated: December 9, 2008
Health Authority: Iran: Ministry of Health

Keywords provided by Qazvin University Of Medical Sciences:
OLP
Free Soft Tissue Graft
Treatment

Additional relevant MeSH terms:
Lichen Planus
Lichen Planus, Oral
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 16, 2014