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Free Soft Tissue Graft in Treatment of Oral Lichen Planus


Phase 1
40 Years
70 Years
Open (Enrolling)
Both
Oral Lichen Planus

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Trial Information

Free Soft Tissue Graft in Treatment of Oral Lichen Planus


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Farshid Rayati, DDS

Investigator Role:

Study Director

Investigator Affiliation:

Qazvin University Of Medical Sciences

Authority:

Iran: Ministry of Health

Study ID:

ACTG022

NCT ID:

NCT00737854

Start Date:

May 2008

Completion Date:

December 2010

Related Keywords:

  • Oral Lichen Planus
  • OLP
  • Free Soft Tissue Graft
  • Treatment
  • Lichen Planus
  • Lichen Planus, Oral

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