Oral Lichen PlanusPhase 1TOLPNCT00737854
Free Soft Tissue Graft in Treatment of Oral Lichen Planus
A Phase 1 study testing Surgical resection in people with Oral Lichen Planus, run by Qazvin University Of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Surgical resection
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- May 2008to Dec 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Farshid - Rayati, DDS contact
Iran1 site, 1 recruiting
- Recruiting
Qazvin University of Medical Sciences
Qazvin, Qazvin State, 3415759811
Farshid Rayati, DDS, farshidrayati@yahoo.com
About this study
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.
Read the 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.
- Conditions
- Oral Lichen Planus
- Being tested
- Surgical resection
- Keywords
- OLP, Free Soft Tissue Graft, Treatment
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical resectionProcedure or surgery
Also called surgical resection of OLP
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 ARM | Experimental | Otherwise healthy patients with oral lichen planus (precancerous/erosive OLP) Receives: Procedure: Surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of sign & symptoms (every 2 month up to 1 years)
Measured: 1 year
Secondary outcomes (1)
Relief of sign & symptoms and no positive histopathologic features of OLP
Measured: (time frame 1 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Farshid Rayati, DDS, Study director, Qazvin University Of Medical SciencesTuba(Aida) Karagah, DDS, Principal investigator, QUMSFarshid Rayati, DDS, Study chair, QUMSSaeid Asefzadeh, PHD, Study chair, QUMSPoopak masumi, DDS-MS, Study director, QUMSpourya falah, student, Principal investigator, QUMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737854
- Sponsor's protocol ID
- ACTG022
- Acronym
- TOLP
- Status last verified
- Aug 2008
- First submitted
- 18 Aug 2008
- Last updated
- 11 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Free Soft Tissue Graft in Treatment of Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT00737854
- Acronym / sponsor ID
- TOLP / ACTG022
- Conditions
- Oral Lichen Planus
- Keywords
- OLP, Free Soft Tissue Graft, Treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 20 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 ARM | Experimental | Procedure: Surgical resectionOtherwise healthy patients with oral lichen planus (precancerous/erosive OLP) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical resectionAlso: surgical resection of OLP20 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. | Procedure or surgery | 1 ARM |
Primary outcome
Relief of sign & symptoms (every 2 month up to 1 years)
Time frame: 1 year
1 secondary outcome
Relief of sign & symptoms and no positive histopathologic features of OLP
Time frame: (time frame 1 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2008.
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Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farshid - Rayati, DDS contact
Farshid Rayati, DDS study director
Qazvin University Of Medical Sciences
Tuba(Aida) Karagah, DDS principal investigator
QUMS
Farshid Rayati, DDS study chair
QUMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Surgical resection in people with Oral Lichen Planus, run by Qazvin University Of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farshid - Rayati, DDS (farshidrayati@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief of sign & symptoms (every 2 month up to 1 years) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2008.