Erosive and Atrophic Oral Lichen Planus Clinical Trial
Official title:
Cedar Honey in Treatment of Oral Lichen Planus: a Randomized Clinical Trial
| Verified date | October 2013 |
| Source | Mashhad University of Medical Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Iran: Ministry of Health |
| Study type | Interventional |
The study aimed to evaluate the effect of cedar honey in treatment of erosive and atrophic oral lichen planus ( a common oral problem).
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | December 2012 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Iran, Islamic Republic of | Oral Medicine Department of Mashhad dental School,Oral and Maxillofacial diseases research center | Mashhad | Khorasan Razavi |
| Lead Sponsor | Collaborator |
|---|---|
| Mashhad University of Medical Sciences |
Iran, Islamic Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | pain of lesions | 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 | No |
| Primary | severity of lesions | severity of lesions due to thong prasom criteria | 4 weeks | No |
| Secondary | 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. | 4 weeks | No |