Facial AsymmetryNCT01879969
Computer Assisted Orthognathic Surgery. Facial Asymmetry
A study testing classic procedure of planning and computer assisted orthognathic planning and surgery of asymmetric patients in people with Facial Asymmetry, run by Università degli Studi di Sassari at 1 site in Italy.
Trial summary
The specific aims of the study were to measure and compare the rates of alignment and cant reduction of the dental and facial midlines among the two groups. Read more about this study
- Who is it for?
- Ages 21 to 54 years
- Conditions the study is for
- Facial Asymmetry
- What is being tested?
- classic procedure of planning and computer assisted orthognathic planning and surgery of asymmetric patients
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2009to Jan 2012
- 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 to 54 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- facial asymmetry or mandibular deviation (cant of the occlusal plane > 3° and/or midline discrepancies > 2.5 mm)
- presence of all central incisors,
- pre- and postoperative radiographs and plaster casts (group 1)
- cranial CBCT images (group 2)
- pre- and postoperative digital photographs.
Who cannot join
- previous trauma involving the hard or soft facial tissues
- functional deviation of the mandible
- incomplete records (CBCT, radiographs, casts or digital photographs).
Trial locations and contacts
1 site in 1 country.
About this study
The specific aims of the study were to measure and compare the rates of alignment and cant reduction of the dental and facial midlines among the two groups.
Read the detailed description
The purpose of this randomized, controlled, clinical study, was to evaluate the most accurate procedure for orthognathic correction of facial asymmetry. The investigators compared two different methods of surgical planning: classical (esthetic analysis of the face, cephalometric study of the skull in lateral and posteroanterior cephalograms, analysis and surgical simulation of plaster casts mounted in semi-individual articulators, development of a surgical acrylic resin intermediate splint) and digital planning (cone-beam computed tomography, data acquisition, software-assisted virtual surgery -Maxilim; Medicim, Mechelen, Belgium- and CAD/CAM processing of the surgical intermediate splint).
- Conditions
- Facial Asymmetry
- Being tested
- classic procedure of planning, computer assisted orthognathic planning and surgery of asymmetric patients
- Keywords
- computer-assisted orthognathic surgery; facial asymmetry
- Medical subject headings
- Facial Asymmetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
classic procedure of planningProcedure or surgery
analysis of pictures, 2D radiographs and aesthetics; model surgery and acrylic splint
computer assisted orthognathic planning and surgery of asymmetric patientsProcedure or surgery
Also called CBCT, data acquisition and processing; virtual surgery and CAD/CAM intermediate splint
| Study group | Role | What they receive |
|---|---|---|
| asymmetric patients, classic procedure | Experimental | random selected Receives: Procedure: classic procedure of planning |
| asymmetric patients, computer assisted | Experimental | random selected Receives: Procedure: computer assisted orthognathic planning and surgery of asymmetric patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in linear measures
More specifically were measured: distance from the upper interincisal point to the facial midline; distance from the lower interincisal point to the facial midline; distance between interincisal points; distance from skeletal menton to the facial midline; distance from soft tissue menton to the facial midline;
Measured: Preoperative (baseline)-Postoperative (up to 1 month)
Change in angular measures
More specifically were measured:distance from the maxillary sagittal plane to the facial mid-sagittal plane; distance from the mandibular sagittal plane to the facial mid-sagittal plane.
Measured: Preoperative (baseline)- Postoperative (up to one month)
Secondary outcomes (4)
age of patients
age at surgery
Measured: Preoperative (baseline)
Type of surgery needed
How many patients had genioplasty added to the standard bimaxillary surgery plan
Measured: Preoperative (baseline)
sample size
number of patients
Measured: Preoperative (baseline)
gender
male/female
Measured: Preoperative (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startDec 2009
- Primary completionNov 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial AsymmetryStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Sassari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvio Mario Meloni, Università degli Studi di Sassari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879969
- Sponsor's protocol ID
- IDM 06/06/13
- Status last verified
- Jun 2013
- First submitted
- 6 Jun 2013
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Assisted Orthognathic Surgery. Facial Asymmetry
- ClinicalTrials.gov ID
- NCT01879969
- Acronym / sponsor ID
- IDM 06/06/13
- Conditions
- Facial Asymmetry
- Keywords
- computer-assisted orthognathic surgery; facial asymmetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Università degli Studi di SassariUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 18 Jun 2013 (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 specific aims of the study were to measure and compare the rates of alignment and cant reduction of the dental and facial midlines among the two groups.
Detailed description
The purpose of this randomized, controlled, clinical study, was to evaluate the most accurate procedure for orthognathic correction of facial asymmetry. The investigators compared two different methods of surgical planning: classical (esthetic analysis of the face, cephalometric study of the skull in lateral and posteroanterior cephalograms, analysis and surgical simulation of plaster casts mounted in semi-individual articulators, development of a surgical acrylic resin intermediate splint) and digital planning (cone-beam computed tomography, data acquisition, software-assisted virtual surgery -Maxilim; Medicim, Mechelen, Belgium- and CAD/CAM processing of the surgical intermediate splint).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| asymmetric patients, classic procedure | Experimental | Procedure: classic procedure of planningrandom selected |
| asymmetric patients, computer assisted | Experimental | Procedure: computer assisted orthognathic planning and surgery of asymmetric patientsrandom selected |
Who may qualify
- Ages
- 21 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- facial asymmetry or mandibular deviation (cant of the occlusal plane > 3° and/or midline discrepancies > 2.5 mm)
- presence of all central incisors,
- pre- and postoperative radiographs and plaster casts (group 1)
- cranial CBCT images (group 2)
- pre- and postoperative digital photographs.
Key exclusion criteria (3 listed)
- previous trauma involving the hard or soft facial tissues
- functional deviation of the mandible
- incomplete records (CBCT, radiographs, casts or digital photographs).
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 |
|---|---|---|
| classic procedure of planninganalysis of pictures, 2D radiographs and aesthetics; model surgery and acrylic splint | Procedure or surgery | asymmetric patients, classic procedure |
| computer assisted orthognathic planning and surgery of asymmetric patientsAlso: CBCT, data acquisition and processing; virtual surgery and CAD/CAM intermediate splint | Procedure or surgery | asymmetric patients, computer assisted |
Primary outcome
Change in linear measures
Time frame: Preoperative (baseline)-Postoperative (up to 1 month)
More specifically were measured: distance from the upper interincisal point to the facial midline; distance from the lower interincisal point to the facial midline; distance between interincisal points; distance from skeletal menton to the facial midline; distance from soft tissue menton to the facial midline;
Change in angular measures
Time frame: Preoperative (baseline)- Postoperative (up to one month)
More specifically were measured:distance from the maxillary sagittal plane to the facial mid-sagittal plane; distance from the mandibular sagittal plane to the facial mid-sagittal plane.
4 secondary outcomes
age of patients
Time frame: Preoperative (baseline)
Type of surgery needed
Time frame: Preoperative (baseline)
sample size
Time frame: Preoperative (baseline)
gender
Time frame: Preoperative (baseline)
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 19 Jun 2013.
Related trials for Facial Asymmetry
RecruitingObservational study
Driving Time and Facial Skin Hydration Asymmetry in Florida Drivers
Skin Diseases, Photoaging
Recruiting
Treatment for "Asymmetric Crying Facies"
Hemifacial Microsomia, Facial Nerve Paralysis
Recruiting
Combined Effects of Proprioceptive Neuromuscular Facilitation (PNF) and Neural Mobilization on Improving Facial Symmetry in Patients With Bells Palsy
Bell's Palsy, Facial Paralysis
RecruitingPhase 4
Evaluation of Filler Injection for Chin Profile Enhancement
Chin Regression, Chin Asymmetry
Recruiting
Clinical Evaluation of Patient-Specific 3D-Printed Titanium Implants for Facial Reconstruction.
Hemifacial Microsomia, Mucormycosis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing classic procedure of planning and computer assisted orthognathic planning and surgery of asymmetric patients in people with Facial Asymmetry, run by Università degli Studi di Sassari at 1 site in Italy.
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 5 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 19 Jun 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 Italy. 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?
Change in linear measures (time frame: Preoperative (baseline)-Postoperative (up to 1 month)). The study lists 2 primary outcomes in all. 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 19 Jun 2013.