Cedar Honey in Oral Lichen Planus

Phase 1

Completed

• Conditions: Erosive and Atrophic Oral Lichen Planus
• Interventions: Drug: orally administered cedar honey

• Registration Number: NCT01974414
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Status Verified: 2013-10
• Study First Submitted: 2013-10-26
• Study First Submitted QC: 2013-10-26
• Last Update Submitted: 2013-10-26
• Study First Posted: 2013-11-01
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cedar honey	orally administered 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 .

Primary Outcome Measures

Name	Time	Method
severity of lesions	4 weeks	severity of lesions due to thong prasom criteria

Secondary Outcome Measures

Name	Time	Method
size of lesions	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.

Trial Locations

Locations (1)

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