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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00737854
Recruitment Status : Unknown
Verified August 2008 by Qazvin University Of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : August 20, 2008
Last Update Posted : December 11, 2008
Sponsor:
Information provided by:
Qazvin University Of Medical Sciences

Tracking Information
First Submitted Date  ICMJE August 18, 2008
First Posted Date  ICMJE August 20, 2008
Last Update Posted Date December 11, 2008
Study Start Date  ICMJE May 2008
Estimated Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2008)
Relief of sign & symptoms (every 2 month up to 1 years) [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2008)
Relief of sign & symptoms and no positive histopathologic features of OLP [ Time Frame: (time frame 1 years) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Free Soft Tissue Graft in Treatment of Oral Lichen Planus
Official Title  ICMJE Free Soft Tissue Graft in Treatment of Oral Lichen Planus
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Oral Lichen Planus
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: 1 ARM
Otherwise healthy patients with oral lichen planus (precancerous/erosive OLP)
Intervention: Procedure: Surgical resection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 19, 2008)
20
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2010
Estimated Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00737854
Other Study ID Numbers  ICMJE ACTG022
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Qazvin University Of Medical Sciences, Qazvin University Of Medical Sciences . Deputy of Research
Study Sponsor  ICMJE Qazvin University Of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Qazvin University Of Medical Sciences
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP