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NCT00596141 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00596141
Other study ID # ORO_PG_LSU_1_08
Secondary ID
Status Completed
Phase N/A
First received January 5, 2008
Last updated May 6, 2013
Start date February 2008
Est. completion date May 2009

Study information
Verified date May 2013
Source OroScience, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States LSU School of Dentistry, Dental Clinics New Orleans Louisiana

Sponsors (2)
Lead Sponsor Collaborator
OroScience, Inc. Louisiana State University Health Sciences Center in New Orleans

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visible signs of inflammation scored on a scale of 1 to 4 by three (3) blinded investigators. Three (3) and seven (7) days postoperatively No
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