Oral Surgical ProceduresNCT00596141
Pilot Study to Evaluate the Use of OroScience Topical Oral Wound Emulsion in Post Operative Wound Healing
A study testing OroScience Topical Oral Wound Emulsion in people with Oral Surgical Procedures and Pain, run by OroScience, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Oral Surgical Procedures, Pain
- What is being tested?
- OroScience Topical Oral Wound Emulsion
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned dental treatment includes intraoral surgery involving full thickness mucoperiosteal flaps with at least one vertical releasing incision
Who cannot join
- Complicated medical history
- History of poor patient compliance
- Presence or placement of materials beneath the suture site
Trial locations and contacts
1 site in 1 country.
United States1 site
LSU School of Dentistry, Dental Clinics
New Orleans, Louisiana, 70119
About this study
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.
- Conditions
- Oral Surgical Procedures, Pain
- Being tested
- OroScience Topical Oral Wound Emulsion
- Keywords
- oral periodontal gingival intraoral mucosal mucoperiosteal, Surgery, Oral
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: OroScience Topical Oral Wound Emulsion |
| 2 | No intervention | Conventional postoperative care and instructions on dental hygiene. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visible signs of inflammation scored on a scale of 1 to 4 by three (3) blinded investigators.
Measured: Three (3) and seven (7) days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- OroScience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Louisiana State University Health Sciences Center in New Orleans
- Responsible party
- Sponsor
- Investigators
- Billie G Jeansonne, DDS, PhD, Principal investigator, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596141
- Sponsor's protocol ID
- ORO_PG_LSU_1_08
- Status last verified
- May 2013
- First submitted
- 5 Jan 2008
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Use of OroScience Topical Oral Wound Emulsion in Post Operative Wound Healing
- ClinicalTrials.gov ID
- NCT00596141
- Acronym / sponsor ID
- ORO_PG_LSU_1_08
- Conditions
- Oral Surgical Procedures, Pain
- Keywords
- oral periodontal gingival intraoral mucosal mucoperiosteal, Surgery, Oral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- OroScience, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Louisiana State University Health Sciences Center in New Orleans
- Study start
- Feb 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: OroScience Topical Oral Wound EmulsionConventional 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). |
| 2 | No intervention | –Conventional postoperative care and instructions on dental hygiene. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Planned dental treatment includes intraoral surgery involving full thickness mucoperiosteal flaps with at least one vertical releasing incision
Key exclusion criteria (3 listed)
- Complicated medical history
- History of poor patient compliance
- Presence or placement of materials beneath the suture site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OroScience Topical Oral Wound EmulsionTOWE 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. | Device | 1 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Billie G Jeansonne, DDS, PhD principal investigator
Louisiana State University Health Sciences Center in New Orleans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OroScience Topical Oral Wound Emulsion in people with Oral Surgical Procedures and Pain, run by OroScience, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2013.