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

NCT ID: NCT00596141

Last Updated: 2013-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Oral Surgical Procedures Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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).

Group Type EXPERIMENTAL

OroScience Topical Oral Wound Emulsion

Intervention Type DEVICE

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

Conventional postoperative care and instructions on dental hygiene.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role collaborator

OroScience, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Billie G Jeansonne, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Louisiana State University Health Sciences Center in New Orleans

Locations

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LSU School of Dentistry, Dental Clinics

New Orleans, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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ORO_PG_LSU_1_08

Identifier Type: -

Identifier Source: org_study_id

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