- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01680042
Clinical Effect of Phenytoin Mucoadhesive Paste on Wound Healing After Oral Biopsy
October 1, 2012 updated by: somayeh alirezaei, Shahid Beheshti University of Medical Sciences
Phase 1 Study of Phenytoin Mucoadhesive Paste for Wound Healing After Oral Biopsy
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: somayeh alirezaei, DDS
- Phone Number: 09123705943
- Email: dr.somayehalirezaei@gmail.com
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Recruiting
- Shaheed Beheshti University
-
Contact:
- somayeh alirezaei, resident
- Phone Number: 09190129151
- Email: somayeh_alirezaei_dentist@yahoo.com
-
Principal Investigator:
- somayeh alirezaei, resident
-
Tehran, Iran, Islamic Republic of
- Not yet recruiting
- Shahid beheshti medical University
-
Contact:
- somayeh alirezaei, DDS
- Phone Number: 09123705943
- Email: dr.somayehalirezaei@gmail.com
-
Principal Investigator:
- somayeh alirezaei, DDS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients undergone oral biopsy
Exclusion Criteria:
- systemic disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: phenytoin paste
this group receives phenytoin paste after oral biopsy
|
|
Placebo Comparator: usual mucoadhesive paste
this group receives the usual mucoadhesive paste without phenytoin after oral biopsy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
healing biopsy wound
Time Frame: 7 days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Anticipated)
March 1, 2013
Study Registration Dates
First Submitted
September 3, 2012
First Submitted That Met QC Criteria
September 5, 2012
First Posted (Estimate)
September 6, 2012
Study Record Updates
Last Update Posted (Estimate)
October 2, 2012
Last Update Submitted That Met QC Criteria
October 1, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Merck-023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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