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

Purpose

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.

Condition	Intervention
Oral Surgical Procedures Pain	Device: OroScience Topical Oral Wound Emulsion

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by OroScience, Inc.:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	20
Study Start Date:	February 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: 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).	Device: OroScience Topical Oral Wound Emulsion TOWE will be applied 3 times daily for a period of 7 days by the patient dispensing TOWE into a disposable dental tray and placing the dental tray over the dental arch and covering the surgical site.
2: No Intervention Conventional postoperative care and instructions on dental hygiene.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596141

Contacts


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

Contact: Sartirios Vastardis, DDS, MS

Locations


United States, Louisiana
	LSU School of Dentistry, Dental Clinics	Recruiting
	New Orleans, Louisiana, United States, 70119
	Sub-Investigator: Leneise Lynn, DDS, PhD
	Sub-Investigator: Sartirios Vastardis, DDS, MS

Sponsors and Collaborators

OroScience, Inc.

Louisiana State University

Investigators


Principal Investigator:	Billie G Jeansonne, DDS, PhD	Louisiana State University

More Information

Responsible Party:	LSU School of Dentistry Deptartment of Endodontics ( Dr. Billie Gail Jeansonne, DDS, PhD )
Study ID Numbers:	ORO_PG_LSU_1_08
First Received:	January 5, 2008
Last Updated:	February 11, 2008
ClinicalTrials.gov Identifier:	NCT00596141
Health Authority:	United States: Institutional Review Board

Keywords provided by OroScience, Inc.:

oral periodontal gingival intraoral mucosal mucoperiosteal

Surgery, Oral

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on August 20, 2008

Sponsors and Collaborators:	OroScience, Inc. Louisiana State University
Information provided by:	OroScience, Inc.
ClinicalTrials.gov Identifier:	NCT00596141