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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by somayeh alirezaei, Shaheed Beheshti Medical University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01680042
First Posted: September 6, 2012
Last Update Posted: October 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
somayeh alirezaei, Shaheed Beheshti Medical University
  Purpose
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.

Condition Intervention Phase
Wound Healing Pain Drug: Phenytoin paste Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Phenytoin Mucoadhesive Paste for Wound Healing After Oral Biopsy

Resource links provided by NLM:


Further study details as provided by somayeh alirezaei, Shaheed Beheshti Medical University:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: phenytoin paste
this group receives phenytoin paste after oral biopsy
Drug: Phenytoin paste
Placebo Comparator: usual mucoadhesive paste
this group receives the usual mucoadhesive paste without phenytoin after oral biopsy
Drug: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergone oral biopsy

Exclusion Criteria:

  • systemic disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680042


Contacts
Contact: somayeh alirezaei, DDS 09123705943 dr.somayehalirezaei@gmail.com

Locations
Iran, Islamic Republic of
Shaheed Beheshti University Recruiting
Tehran, Iran, Islamic Republic of
Contact: somayeh alirezaei, resident    09190129151    somayeh_alirezaei_dentist@yahoo.com   
Principal Investigator: somayeh alirezaei, resident         
Shahid Beheshti Medical University Not yet recruiting
Tehran, Iran, Islamic Republic of
Contact: somayeh alirezaei, DDS    09123705943    dr.somayehalirezaei@gmail.com   
Principal Investigator: somayeh alirezaei, DDS         
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
  More Information

Responsible Party: somayeh alirezaei, resident, Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier: NCT01680042     History of Changes
Other Study ID Numbers: Merck-023
First Submitted: September 3, 2012
First Posted: September 6, 2012
Last Update Posted: October 2, 2012
Last Verified: October 2012

Keywords provided by somayeh alirezaei, Shaheed Beheshti Medical University:
inflammatory halo
VAS

Additional relevant MeSH terms:
Wounds and Injuries
Phenytoin
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers