Cedar Honey in Oral Lichen Planus

October 26, 2013 updated by: Pegah Mosannen Mozafari, Mashhad University of Medical Sciences

Cedar Honey in Treatment of Oral Lichen Planus: a Randomized Clinical Trial

The study aimed to evaluate the effect of cedar honey in treatment of erosive and atrophic oral lichen planus ( a common oral problem).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Khorasan Razavi
      • Mashhad, Khorasan Razavi, Iran, Islamic Republic of
        • Oral Medicine Department of Mashhad dental School,Oral and Maxillofacial diseases research center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. clinically and histopathologically confirmed oral lichen planus without dysplasia in histopathologic evaluation
  2. Severity of pain≥2 (VAS score)
  3. Severity of lesions≥2 (tong prasom criteria)
  4. absence of any treatment in the last month
  5. absence of kidney or liver diseases( due to systemic administration of fluconazole to both groups)

Exclusion Criteria:

  1. evidence of lichenoid reaction in clinical or histopathologic assessment
  2. loss of follow up
  3. pregnant patients
  4. diabetic patients
  5. any other mucosal disease
  6. any severe systemic disease
  7. patients who refuse doctor's advice
  8. any unexpected adverse effect of honey

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: cedar honey
The two study groups were provided with standard treatment(dexamethasone and Fluconazole).The Case group(A) received cedar honey, 20 ml 3 times daily by swish and swallow technique, in addition to the standard treatment .
Drug: orally administered cedar honey
No Intervention: control group
the control group (B) only received standard treatment(Dexametazone and Fluconazole).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
severity of lesions
Time Frame: 4 weeks
severity of lesions due to thong prasom criteria
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
size of lesions
Time Frame: 4 weeks
A sterile caulis was used to measure the maximum diameter of erosive and atrophic lesions and the maximum width perpendicular to the maximum diameter was recorded.
4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain of lesions
Time Frame: 4 weeks
Pain or burning sensation was assessed by using a visual analog scale (VAS). Patients marked the point from 0(no pain) to 10(extreme pain) representing their present pain perception
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Investigators

  • Study Director: Majid Sanatkhani, Assistant Professor, Mashhad University Of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 26, 2013

First Submitted That Met QC Criteria

October 26, 2013

First Posted (Estimate)

November 1, 2013

Study Record Updates

Last Update Posted (Estimate)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 26, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 900166

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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