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Trial record 11 of 18 for:    Atrophic Lichen Planus

Use of Injectable Platelet Rich Fibrin in Lichen Planus

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: NCT03265093
Recruitment Status : Unknown
Verified September 2017 by Bezmialem Vakif University.
Recruitment status was:  Recruiting
First Posted : August 29, 2017
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):
Bezmialem Vakif University

Brief Summary:

Platelet Rich Fibrine (PRF), which promotes wound healing by supporting angiogenesis, immunity and epithelial proliferation phases. over a decade has since past since PRF was developed and many clinicians now point to the potential use of a liquid version of PRF. a liquid injectable-platelet-rich fibrin (i-PRF) was developed by modifying spin centrifugation forces. At lower centrifugation speeds and by utilizing non-glass centrifugation tubes, the fibrin coagulation could be slowed down at early time points thus generating an injectable PRF. Much like traditional PRF, i-PRF contains an increase in leukocyte number and is further able to stimulate growth factor release.

Lichen planus is a common chronic mucocutaneous inflammatory disorder which generally affect s middle aged adults. Therapeutic methods including topical and systemic corticosteroids for the treatment of oral lichen planus (OLP) are suggested. However, long

-term use of corticosteroids may be associated with local and systemic complications, and moreover, some patients may not be responsive.

The investigators aimed to apply a treatment of autogenous origin (including no foreign products), considering the side effects of our corticosteroids. The study was designed as a split mouth.

The investigators planned to administer I-PRF to one side and intralesional corticosteroid therapy to the other side at patients with bilateral atrophic / erosive oral lichen planus lesions


Condition or disease Intervention/treatment Phase
Lichen Planus Other: Platelet Rich Fibrin Injection Drug: Corticosteroid Not Applicable

Detailed Description:
Lichen planus diagnosis will be made histopathologically. Intraoral photographs and measurements will be taken at the beginning of the treatment and 2 months after the treatment is finished.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Blinded, Parallel group, randomized controlled trial
Masking: Single (Investigator)
Masking Description: Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Current Approach in the Treatment of Lichen Planus: Injectable Platelet Rich Fibrin ((İ-PRF)
Actual Study Start Date : May 3, 2017
Estimated Primary Completion Date : August 24, 2018
Estimated Study Completion Date : December 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Active Comparator: experimental; Corticosteroid
Intralesional corticosteroid administration
Drug: Corticosteroid
Corticosteroid injection

Experimental: Experimental; Injectable Platelet rich fibrin
Injectable Platelet rich fibrin
Other: Platelet Rich Fibrin Injection
Venous blood will be taken from the patient every session and I-PRF will be created in the centrifuge. I- prf will be injected on one side and corticosteroid will be injected on the other side in patients with bilateral oral lichen planus. Once a week in the first month after treatment and one time at the end of the second month, the patient will be called to the control.




Primary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: 3 months ]
    Patients were asked to grade the severity of their symptoms in numbers from 1(very mild pain) to 100 (very sever pain) on the visual analog scale in each visit.

  2. Objective evaluation [ Time Frame: 3 months ]
    The lesions were evaluated according to Thongprasom sign scoring system

  3. Quality of life [ Time Frame: 3 months ]
    The oral health quality of life index (OHQoL-16) Grid in mm.


Secondary Outcome Measures :
  1. Oral Hygiene Index [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Oral erosive lesions were diagnosed according to Andreasen classification.
  2. Histological confirmation of erosive OLP according to the World Health Organization's clinicopathological diagnostic criteria for OLP.
  3. No previous treatment of oral lichen planus at least 3 months.
  4. Willingness and ability to complete the present clinical trial.
  5. Patients of ages above 18 years old without skin involvement.

Exclusion Criteria:

  1. Histological signs of dysplasia.
  2. Using drugs associated with lichenoid reaction.
  3. Pregnant, lactating and smoker patients.
  4. Patient with systemic diseases such as diabetes mellitus, immunodysfunction, hematological and hepatological patients or had photosensitivity history.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265093


Contacts
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Contact: Ebru Sağlam, PhD +905052604617 saglam.ebru@yahoo.com
Contact: Zeliha Betül Özsağır +905076699794 betulozsagir@hotmail.com

Locations
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Turkey
Ebru SAĞLAM Recruiting
İstanbul, Fatih, Turkey, 34093
Contact: Ebru Sağlam, PhD    +905052604617    saglam.ebru@yahoo.com   
Contact: Zeliha Betül Özsağır    +905076699794    betulozsagir@hotmail.com   
Principal Investigator: Mustafa Tunalı, Assoc.Prof.         
Principal Investigator: .Ebru Sağlam, PhD         
Principal Investigator: Tuğba Ünver, PhD         
Principal Investigator: Zeliha Betül Özsağır         
Sponsors and Collaborators
Bezmialem Vakif University
Investigators
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Study Chair: Ebru Sağlam, PhD Bezmialem Vakif University
Study Director: Mustafa Tunalı, Assoc. prof. Bezmialem VakifUniversity
Principal Investigator: Tuğba Ünver, PhD Bezmialem Vakif University
Principal Investigator: Zeliha Betül Özsağır Bezmialem Vakif University

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Responsible Party: Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT03265093     History of Changes
Other Study ID Numbers: EbSAGLAM2
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bezmialem Vakif University:
Pain Measurement
Platelet Activation
Quality of Life
Additional relevant MeSH terms:
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Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases