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Clinical Trials/CTRI/2013/09/004029
CTRI/2013/09/004029RecruitingNot Applicable

EFFICACY OF TOPICAL ALOEVERA IN THE TREATMENT OF ORAL LICHENPLANUS - A CLINICAL TRIAL WITH QUASI EXPERIMENTAL DESIGN

PMS College of Dental Sciences and research1 site in 1 country40 target enrollmentStarted: October 1, 2013Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
It is measured as yes or no on the basis of reduction in size of the lesion clinically and by comparing pre and post treatment photographs. Assessing reduction in burning sensation/ pain using Visual Analog Scale

Study Overview

Brief Summary

Introduction: Oral lichen planus[ OLP] is a chronic inflammatory mucocutaneous disease characterized by outbreaks or flares.1 It affects 0.2-1.9%of the population.2,3Although etiology is unknown, pathogenesis of oral lichenplanus is known to involve an immune disorder,with epithelial damage caused by cytotoxic CD8+lymphocytes1,2,3,4.The disease can produce considerable morbidity and alter patient quality of life,particularly in the presence of ulcerative lesions4,5. A variety of treatments have been proposed for Oral lichen planus:topical or systemic corticosteroids,cyclosporine,retinoids,azathioprine,tacrolimus, pimecrolimus,photochemotherapy and surgery4,5.The main inconvenience of these treatments is represented by the sideeffects they usually produce.3,4 Aloe vera(AV) (Aloe barbadensis miller) is a member of the liliaceae family6 It is widely used as a natural  alternative therapy for various types of diseases, and several studies have suggested the healing ,cosmetic & nutritional benefits of this plant6 .Aloe vera  exerts anti-inflammatory effects through the reduction of leucocyte adhesion &TNF- levels7,8,9  and the effect of topical aloe vera in Oral lichen planus has been studied and reported by Hayes 10 and Choonhakarn et al.11xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Objectives**:** To observe the efficacy of topical aloe vera in oral lichen planus by,

1)  assessing the reduction in size of the lesion by clinical examination

2)assessing  the reduction in burning sensation  using visual analog scale

Materials and Methods: Patients who are diagnosed clinically and histopathologically as having  oral lichen planus will be treated with topical aloe vera .Duration  of  this  study  will be  approximately  1 yr from (june 2012- june 2013) Aloe vera gel will be used here which contains about  70% concentration of  aloe vera .It  is mainly the leaf pulp of  this  plant.Instructions should be given to relieve  stress  by patient councelling & reassuarance  after informed consent.Biopsy will be done under local anesthesia in patients who are clinically diagnosed as having Oral Lichen planus in Department of Oral Medicine & Radiology .Pre treatment photographs will be taken  as well as size of the lesion will  be measured every week.Biopsy specimen will be send to the Department of Oral pathology  & Microbiology  for histopathological investigations.After confirming the diagnosis,  treatment  of Oral lichen planus will be carried out  in Oral Medicine department  by topical  aloe vera preparation .Aloe vera gel of 70% concentration will be used [ from Hiran Agroceuticals Pvt Ltd, Madurai, India ].Duration of study/treatment is approximately 1yr.Method  of  application  is topical by using a gauze spatula thrice daily  for 12 weeks.It is allowed to remain in the mouth for 1 minute.After 1minute  patient is asked to swish & spit.Patients will be reviewed  on a weekly basis.On every recall visits  size of lesion will be measured clinically which will be well supported by pre & post treatment photographs .Degree of  burning sensation will be measured  using the Visual analog scale.

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Not Applicable

Eligibility Criteria

Ages
10.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients willing to undergo treatment and participate in the study.Patients clinically and histopathologically diagnosed with oral lichenplanus.

Exclusion Criteria

  • Patients above 70 yrs.
  • Pregnancy and lactating mothers.
  • Mentally challenged patients.
  • Allergic patients.
  • Patients taking drugs capable of producing lichenoid reactions.
  • Presence of dysplasia in histopathologic examination.
  • Patients with other dermatologic lesions.

Outcomes

Primary Outcomes

It is measured as yes or no on the basis of reduction in size of the lesion clinically and by comparing pre and post treatment photographs. Assessing reduction in burning sensation/ pain using Visual Analog Scale

Time Frame: Patients are reviewed weekly for three months.

Secondary Outcomes

  • There will be reduction in pain which will be assessed by the VAS.(Patients are reviewed weekly for 3 months and follow up for 6 months)

Investigators

Sponsor
PMS College of Dental Sciences and research
Sponsor Class
Research institution and hospital

Study Sites (1)

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