NCT00596141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
16 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

May 8, 2013

Status Verified

May 1, 2013

Enrollment Period

1.2 years

First QC Date

January 5, 2008

Last Update Submit

May 6, 2013

Conditions

Oral Surgical ProceduresPain

Keywords

oral periodontal gingival intraoral mucosal mucoperiostealSurgery, Oral

Outcome Measures

Primary Outcomes (1)

  • Visible signs of inflammation scored on a scale of 1 to 4 by three (3) blinded investigators.

    Three (3) and seven (7) days postoperatively

Study Arms (2)

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

2

NO INTERVENTION

Conventional postoperative care and instructions on dental hygiene.

Interventions

OroScience Topical Oral Wound EmulsionDEVICE

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.

1

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Planned dental treatment includes intraoral surgery involving full thickness mucoperiosteal flaps with at least one vertical releasing incision

You may not qualify if:

  • Complicated medical history
  • History of poor patient compliance
  • Presence or placement of materials beneath the suture site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LSU School of Dentistry, Dental Clinics

New Orleans, Louisiana, 70119, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Billie G Jeansonne, DDS, PhD

    Louisiana State University Health Sciences Center in New Orleans

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2008

First Posted

January 16, 2008

Study Start

February 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

May 8, 2013

Record last verified: 2013-05

Locations

US(1)