Free Soft Tissue Graft in Treatment of Oral Lichen Planus (TOLP)
Primary Purpose
Oral Lichen Planus
Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Surgical resection
Sponsored by
About this trial
This is an interventional treatment trial for Oral Lichen Planus focused on measuring OLP, Free Soft Tissue Graft, Treatment
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
Sites / Locations
- Qazvin University of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1 ARM
Arm Description
Otherwise healthy patients with oral lichen planus (precancerous/erosive OLP)
Outcomes
Primary Outcome Measures
Relief of sign & symptoms (every 2 month up to 1 years)
Secondary Outcome Measures
Relief of sign & symptoms and no positive histopathologic features of OLP
Full Information
NCT ID
NCT00737854
First Posted
August 18, 2008
Last Updated
December 9, 2008
Sponsor
Qazvin University Of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00737854
Brief Title
Free Soft Tissue Graft in Treatment of Oral Lichen Planus
Acronym
TOLP
Official Title
Free Soft Tissue Graft in Treatment of Oral Lichen Planus
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Qazvin University Of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus
Keywords
OLP, Free Soft Tissue Graft, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 ARM
Arm Type
Experimental
Arm Description
Otherwise healthy patients with oral lichen planus (precancerous/erosive OLP)
Intervention Type
Procedure
Intervention Name(s)
Surgical resection
Other Intervention Name(s)
surgical resection of OLP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Relief of sign & symptoms (every 2 month up to 1 years)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Relief of sign & symptoms and no positive histopathologic features of OLP
Time Frame
(time frame 1 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Farshid - Rayati, DDS
Email
farshidrayati@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farshid Rayati, DDS
Organizational Affiliation
Qazvin University Of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tuba(Aida) Karagah, DDS
Organizational Affiliation
QUMS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Farshid Rayati, DDS
Organizational Affiliation
QUMS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Saeid Asefzadeh, PHD
Organizational Affiliation
QUMS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Poopak masumi, DDS-MS
Organizational Affiliation
QUMS
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
pourya falah, student
Organizational Affiliation
QUMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qazvin University of Medical Sciences
City
Qazvin
State/Province
Qazvin State
ZIP/Postal Code
3415759811
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farshid Rayati, DDS
Email
farshidrayati@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Free Soft Tissue Graft in Treatment of Oral Lichen Planus
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