Cedar Honey in Oral Lichen Planus

Overview

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

Full Title of Study: “Cedar Honey in Treatment of Oral Lichen Planus: a Randomized Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: September 2012

Interventions

  • Drug: orally administered cedar honey

Arms, Groups and Cohorts

  • 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 .
  • No Intervention: control group
    • the control group (B) only received standard treatment(Dexametazone and Fluconazole).

Clinical Trial Outcome Measures

Primary Measures

  • severity of lesions
    • Time Frame: 4 weeks
    • severity of lesions due to thong prasom criteria

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mashhad University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Pegah Mosannen Mozafari, Assistant professor of Oral medicine – Mashhad University of Medical Sciences
  • Overall Official(s)
    • Majid Sanatkhani, Assistant Professor, Study Director, Mashhad University of Medical Sciences

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