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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:


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.

  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