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

This study is currently recruiting participants.

Verified by OroScience, Inc., January 2009

First Received: January 5, 2008 Last Updated: January 19, 2009 History of Changes

Sponsor:	OroScience, Inc.
Collaborator:	Louisiana State University
Information provided by:	OroScience, Inc.
ClinicalTrials.gov Identifier:	NCT00596141

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

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

Resource links provided by NLM:

MedlinePlus related topics: Surgery

U.S. FDA Resources

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:	July 2009
Estimated Primary Completion Date:	July 2009 (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.

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

No publications provided

Responsible Party:	LSU School of Dentistry Deptartment of Endodontics ( Dr. Billie Gail Jeansonne, DDS, PhD )
Study ID Numbers:	ORO_PG_LSU_1_08
Study First Received:	January 5, 2008
Last Updated:	January 19, 2009
ClinicalTrials.gov Identifier:	NCT00596141 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by OroScience, Inc.:

oral periodontal gingival intraoral mucosal mucoperiosteal
Surgery, Oral

ClinicalTrials.gov processed this record on November 30, 2009