Dentofacial DeformityNCT01530100
Lower Laser Therapy in Orthognathics Surgery
An observational study of Dentofacial Deformity, run by Universidade Federal de Goias.
Trial summary
This study will examine the use of lower laser therapy to reduce edema and pain in orthognathics surgery. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dentofacial Deformity
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to May 2013
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: community sample
Who may be able to join
- Dentofacial deformity
- Healthy
- Mandibular surgery
- no medication use
Who cannot join
None listed.
About this study
Official title: Lower Laser Therapy in Orthognathics Surgery - Double Blind Study.
This study will examine the use of lower laser therapy to reduce edema and pain in orthognathics surgery.
- Conditions
- Dentofacial Deformity
- Keywords
- Edema, Pain, Lower laser therapy, orthognathics surgery
- Medical subject headings
- Dentofacial Deformities, Edema, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
edema, pain and neurosensory disturbancy
edema, pain and neurosensory disturbancy, response to lasr therapy
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dentofacial DeformityStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Goias
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Gasperini, Universidade Federal de Goias
- Investigators
- Giovanni Gasperini, master, Principal investigator, UFG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530100
- Sponsor's protocol ID
- LLTOS
- Status last verified
- Feb 2012
- First submitted
- 6 Feb 2012
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gasperini G, Rodrigues de Siqueira IC, Rezende Costa L. Does low-level laser therapy decrease swelling and pain resulting from orthognathic surgery? Int J Oral Maxillofac Surg. 2014 Jul;43(7):868-73. doi: 10.1016/j.ijom.2014.02.015. Epub 2014 Mar 25.
PubMed 24679851Gasperini G, de Siqueira IC, Costa LR. Lower-level laser therapy improves neurosensory disorders resulting from bilateral mandibular sagittal split osteotomy: a randomized crossover clinical trial. J Craniomaxillofac Surg. 2014 Jul;42(5):e130-3. doi: 10.1016/j.jcms.2013.07.009. Epub 2013 Sep 4.
PubMed 24011464
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Laser Therapy in Orthognathics Surgery - Double Blind Study.
- ClinicalTrials.gov ID
- NCT01530100
- Acronym / sponsor ID
- LLTOS
- Conditions
- Dentofacial Deformity
- Keywords
- Edema, Pain, Lower laser therapy, orthognathics surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 9 Feb 2012 (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.
This study will examine the use of lower laser therapy to reduce edema and pain in orthognathics surgery.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- community sample
Key inclusion criteria (4 listed)
- Dentofacial deformity
- Healthy
- Mandibular surgery
- no medication use
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
edema, pain and neurosensory disturbancy
Time frame: 2 months
edema, pain and neurosensory disturbancy, response to lasr therapy
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 2 Dec 2014.
- Derived from this study: PubMed 24679851Gasperini G, Rodrigues de Siqueira IC, Rezende Costa L. Does low-level laser therapy decrease swelling and pain resulting from orthognathic surgery? Int J Oral Maxillofac Surg. 2014 Jul;43(7):868-73. doi: 10.1016/j.ijom.2014.02.015. Epub 2014 Mar 25.
- Derived from this study: PubMed 24011464Gasperini G, de Siqueira IC, Costa LR. Lower-level laser therapy improves neurosensory disorders resulting from bilateral mandibular sagittal split osteotomy: a randomized crossover clinical trial. J Craniomaxillofac Surg. 2014 Jul;42(5):e130-3. doi: 10.1016/j.jcms.2013.07.009. Epub 2013 Sep 4.
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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.
Giovanni Gasperini, master principal investigator
UFG
Questions about this trial
What is this clinical trial studying?
An observational study of Dentofacial Deformity, run by Universidade Federal de Goias.
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 4 inclusion and 0 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 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
edema, pain and neurosensory disturbancy (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01530100, which also lists 2 linked publications.
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 2 Dec 2014.