Back to resultsPilot Study to Evaluate the Use of OroScience Topical Oral Wound Emulsion in Post Operative Wound Healing
Primary Purpose
Oral Surgical Procedures, Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OroScience Topical Oral Wound Emulsion
Sponsored by
About this trial
This is an interventional treatment trial for Oral Surgical Procedures focused on measuring oral periodontal gingival intraoral mucosal mucoperiosteal, Surgery, Oral
Eligibility 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
Sites / Locations
- LSU School of Dentistry, Dental Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
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).
Conventional postoperative care and instructions on dental hygiene.
Outcomes
Primary Outcome Measures
Visible signs of inflammation scored on a scale of 1 to 4 by three (3) blinded investigators.
Secondary Outcome Measures
Full Information
NCT ID
NCT00596141
First Posted
January 5, 2008
Last Updated
May 6, 2013
Sponsor
OroScience, Inc.
Collaborators
Louisiana State University Health Sciences Center in New Orleans
1. Study Identification
Unique Protocol Identification Number
NCT00596141
Brief Title
Pilot Study to Evaluate the Use of OroScience Topical Oral Wound Emulsion in Post Operative Wound Healing
Official Title
Pilot Study to Evaluate the Use of OroScience Topical Oral Wound Emulsion in Post Operative Wound Healing
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OroScience, Inc.
Collaborators
Louisiana State University Health Sciences Center in New Orleans
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Surgical Procedures, Pain
Keywords
oral periodontal gingival intraoral mucosal mucoperiosteal, Surgery, Oral
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
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).
Arm Title
2
Arm Type
No Intervention
Arm Description
Conventional postoperative care and instructions on dental hygiene.
Intervention Type
Device
Intervention Name(s)
OroScience Topical Oral Wound Emulsion
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Billie G Jeansonne, DDS, PhD
Organizational Affiliation
Louisiana State University Health Sciences Center in New Orleans
Official's Role
Principal Investigator
Facility Information:
Facility Name
LSU School of Dentistry, Dental Clinics
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Study to Evaluate the Use of OroScience Topical Oral Wound Emulsion in Post Operative Wound Healing
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