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Cedar Honey in Oral Lichen Planus

NCT ID: NCT01974414

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Erosive and Atrophic Oral Lichen Planus

Keywords

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oral lichen planus cedar honey atrophic erosive pain treatment clinical trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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 .

Group Type ACTIVE_COMPARATOR

orally administered cedar honey

Intervention Type DRUG

control group

the control group (B) only received standard treatment(Dexametazone and Fluconazole).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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orally administered cedar honey

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Pegah Mosannen Mozafari

Assistant professor of Oral medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Majid Sanatkhani, Assistant Professor

Role: STUDY_DIRECTOR

Mashhad University of Medical Sciences

Locations

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Oral Medicine Department of Mashhad dental School,Oral and Maxillofacial diseases research center

Mashhad, Khorasan Razavi, Iran

Site Status

Countries

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Iran

Other Identifiers

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900166

Identifier Type: -

Identifier Source: org_study_id