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

Primary Purpose

Wound Healing, Pain

Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Phenytoin paste
Placebo
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Healing focused on measuring inflammatory halo, VAS

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients undergone oral biopsy

Exclusion Criteria:

  • systemic disease

Sites / Locations

  • Shaheed Beheshti UniversityRecruiting
  • Shahid Beheshti Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

phenytoin paste

usual mucoadhesive paste

Arm Description

this group receives phenytoin paste after oral biopsy

this group receives the usual mucoadhesive paste without phenytoin after oral biopsy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 3, 2012
Last Updated
October 1, 2012
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01680042
Brief Title
Clinical Effect of Phenytoin Mucoadhesive Paste on Wound Healing After Oral Biopsy
Official Title
Phase 1 Study of Phenytoin Mucoadhesive Paste for Wound Healing After Oral Biopsy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing, Pain
Keywords
inflammatory halo, VAS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
phenytoin paste
Arm Type
Active Comparator
Arm Description
this group receives phenytoin paste after oral biopsy
Arm Title
usual mucoadhesive paste
Arm Type
Placebo Comparator
Arm Description
this group receives the usual mucoadhesive paste without phenytoin after oral biopsy
Intervention Type
Drug
Intervention Name(s)
Phenytoin paste
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
healing biopsy wound
Description
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
Time Frame
7 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients undergone oral biopsy Exclusion Criteria: systemic disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
somayeh alirezaei, DDS
Phone
09123705943
Email
dr.somayehalirezaei@gmail.com
Facility Information:
Facility Name
Shaheed Beheshti University
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
somayeh alirezaei, resident
Phone
09190129151
Email
somayeh_alirezaei_dentist@yahoo.com
First Name & Middle Initial & Last Name & Degree
somayeh alirezaei, resident
Facility Name
Shahid Beheshti Medical University
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
somayeh alirezaei, DDS
Phone
09123705943
Email
dr.somayehalirezaei@gmail.com
First Name & Middle Initial & Last Name & Degree
somayeh alirezaei, DDS

12. IPD Sharing Statement

Learn more about this trial

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

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