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NCT01680042 Clinical Trial

Clinical Effect of Phenytoin Mucoadhesive Paste on Wound Healing After Oral Biopsy

Pain Clinical Trial

Official title:
Phase 1 Study of Phenytoin Mucoadhesive Paste for Wound Healing After Oral Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01680042
Other study ID # Merck-023
Secondary ID
Status Recruiting
Phase Phase 1
First received September 3, 2012
Last updated October 1, 2012
Start date October 2012

Study information
Verified date October 2012
Source hahid Beheshti University of Medical Sciences
Contact somayeh alirezaei, DDS
Phone 09123705943
Email dr.somayehalirezaei@gmail.com
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

several studies have investigated healing effect of phenytoin.In this study we investigate healing effect of phenytoin mucoadhesive paste comparing to the usual mucoadhesive paste after oral biopsy.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- patients undergone oral biopsy

Exclusion Criteria:

- systemic disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Phenytoin paste

• Placebo

Locations
Country Name City State
Iran, Islamic Republic of Shaheed Beheshti University Tehran
Iran, Islamic Republic of Shahid Beheshti Medical University Tehran

Sponsors (1)
Lead Sponsor Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary healing biopsy wound patient recieves phenytoin mucoadhesive paste after oral biopsy and the diameter of inflammatory halo is determined in 1,3,5and the 7th days.pain measurment is also assesed by VAS score 7 days No
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