Back to resultsCedar Honey in Oral Lichen Planus
Primary Purpose
Erosive and Atrophic Oral Lichen Planus
Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
orally administered cedar honey
Sponsored by
About this trial
This is an interventional treatment trial for Erosive and Atrophic Oral Lichen Planus focused on measuring oral lichen planus, cedar honey, atrophic, erosive, pain, treatment, clinical trial
Eligibility Criteria
Inclusion Criteria:
- clinically and histopathologically confirmed oral lichen planus without dysplasia in histopathologic evaluation
- Severity of pain≥2 (VAS score)
- Severity of lesions≥2 (tong prasom criteria)
- absence of any treatment in the last month
- absence of kidney or liver diseases( due to systemic administration of fluconazole to both groups)
Exclusion Criteria:
- evidence of lichenoid reaction in clinical or histopathologic assessment
- loss of follow up
- pregnant patients
- diabetic patients
- any other mucosal disease
- any severe systemic disease
- patients who refuse doctor's advice
- any unexpected adverse effect of honey
Sites / Locations
- Oral Medicine Department of Mashhad dental School,Oral and Maxillofacial diseases research center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
cedar honey
control group
Arm Description
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 .
the control group (B) only received standard treatment(Dexametazone and Fluconazole).
Outcomes
Primary Outcome Measures
severity of lesions
severity of lesions due to thong prasom criteria
Secondary Outcome Measures
size of lesions
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.
Full Information
NCT ID
NCT01974414
First Posted
October 26, 2013
Last Updated
October 26, 2013
Sponsor
Mashhad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01974414
Brief Title
Cedar Honey in Oral Lichen Planus
Official Title
Cedar Honey in Treatment of Oral Lichen Planus: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive and Atrophic Oral Lichen Planus
Keywords
oral lichen planus, cedar honey, atrophic, erosive, pain, treatment, clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cedar honey
Arm Type
Active Comparator
Arm Description
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 .
Arm Title
control group
Arm Type
No Intervention
Arm Description
the control group (B) only received standard treatment(Dexametazone and Fluconazole).
Intervention Type
Drug
Intervention Name(s)
orally administered cedar honey
Primary Outcome Measure Information:
Title
severity of lesions
Description
severity of lesions due to thong prasom criteria
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
size of lesions
Description
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.
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
pain of lesions
Description
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
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinically and histopathologically confirmed oral lichen planus without dysplasia in histopathologic evaluation
Severity of pain≥2 (VAS score)
Severity of lesions≥2 (tong prasom criteria)
absence of any treatment in the last month
absence of kidney or liver diseases( due to systemic administration of fluconazole to both groups)
Exclusion Criteria:
evidence of lichenoid reaction in clinical or histopathologic assessment
loss of follow up
pregnant patients
diabetic patients
any other mucosal disease
any severe systemic disease
patients who refuse doctor's advice
any unexpected adverse effect of honey
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Majid Sanatkhani, Assistant Professor
Organizational Affiliation
Mashhad University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Oral Medicine Department of Mashhad dental School,Oral and Maxillofacial diseases research center
City
Mashhad
State/Province
Khorasan Razavi
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
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Cedar Honey in Oral Lichen Planus
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