NCT01680042

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
25 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Last Updated

October 2, 2012

Status Verified

October 1, 2012

Enrollment Period

5 months

First QC Date

September 3, 2012

Last Update Submit

October 1, 2012

Conditions

Wound HealingPain

Keywords

inflammatory haloVAS

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

phenytoin paste

ACTIVE COMPARATOR

this group receives phenytoin paste after oral biopsy

Drug: Phenytoin paste

usual mucoadhesive paste

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Phenytoin pasteDRUG
phenytoin paste
PlaceboDRUG
usual mucoadhesive paste

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergone oral biopsy

You may not qualify if:

  • systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shaheed Beheshti University

Tehran, Iran

RECRUITING

Shahid Beheshti Medical University

Tehran, Iran

NOT YET RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

somayeh alirezaei, DDS

CONTACT

09123705943dr.somayehalirezaei@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

September 3, 2012

First Posted

September 6, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2013

Last Updated

October 2, 2012

Record last verified: 2012-10

Locations

IR(2)