Pilot Study to Evaluate the Use of OroScience Topical Oral Wound Emulsion in Post Operative Wound Healing - Tabular View

Tracking Information

First Received Date ^ICMJE

January 5, 2008

Last Updated Date

January 19, 2009

Start Date ^ICMJE

February 2008

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Visible signs of inflammation scored on a scale of 1 to 4 by three (3) blinded investigators. [ Time Frame: Three (3) and seven (7) days postoperatively ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00596141 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Pilot Study to Evaluate the Use of OroScience Topical Oral Wound Emulsion in Post Operative Wound Healing

Official Title ^ICMJE

Pilot Study to Evaluate the Use of OroScience Topical Oral Wound Emulsion in Post Operative Wound Healing

Brief Summary

The purpose of this pilot study is to determine if Topical Oral Wound Emulsion (TOWE) assists with dental wound healing and relieves pain from oral wounds.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Oral Surgical Procedures
Pain

Intervention ^ICMJE

Device: OroScience Topical Oral Wound Emulsion

Study Arms / Comparison Groups

Experimental: Conventional postoperative care and instructions on dental hygiene will be provided along with the TOWE treatment which consists of the patient dispensing TOWE into a disposable dental tray and placing the dental tray over the dental arch and covering the surgical site 3 times daily for a period of 7 days. At three (3) days and seven (7) days postoperatively, photographs will be taken of all vertical releasing incisions (before suture removal).
No Intervention: Conventional postoperative care and instructions on dental hygiene.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2009

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Planned dental treatment includes intraoral surgery involving full thickness mucoperiosteal flaps with at least one vertical releasing incision

Exclusion Criteria:

Complicated medical history
History of poor patient compliance
Presence or placement of materials beneath the suture site

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Billie G Jeansonne, DDS, PhD	504-941-8395	BJeans@lsuhsc.edu
Contact: Sartirios Vastardis, DDS, MS

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00596141

Responsible Party

Dr. Billie Gail Jeansonne, DDS, PhD, LSU School of Dentistry Deptartment of Endodontics

Study ID Numbers ^ICMJE

ORO_PG_LSU_1_08

Study Sponsor ^ICMJE

OroScience, Inc.

Collaborators ^ICMJE

Louisiana State University

Investigators ^ICMJE

Principal Investigator:

Billie G Jeansonne, DDS, PhD

Louisiana State University

Information Provided By

OroScience, Inc.

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP