Orthognathic SurgeryNCT03687307
What Are the Three Dimensional Soft Tissue Changes That Occur After Orthognathic Surgery for Skeletal Class II Patients? Pre-test Post-test Quasi Experimental Study
An observational study of Orthognathic Surgery, run by Cairo University.
Trial summary
the aim of the study is to establish reference data that could be used for the creation of more accurate three dimensional prediction of soft tissue outcome. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Orthognathic Surgery
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Feb 2019to Aug 2021
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients with class 2 skeletal deformity, over 18 years and younger than 40
Who may be able to join
- Patients with class II skeletal deformity
- Patients must be over 18 years of age to allow for growth cessation
- Patients must not have any systemic condition which contraindicates general anaesthesia
Who cannot join
- o patients with cleft palate
- patients with syndromes affecting their craniofacial structure
- patients with facial scars
- patients with severe facial asymmetry
About this study
the aim of the study is to establish reference data that could be used for the creation of more accurate three dimensional prediction of soft tissue outcome.
Read the detailed description
in this study, 15 skeletal class 2 orthognathic patients will be selected. CBCT and proface will be done preoperatively. after the surgery and 6 months later the imaging investigations will be repeated to investigate the soft tissue changes that have resulted due to the bone movement.
- Conditions
- Orthognathic Surgery
- Keywords
- class II,, soft tissue changes, CBCT
What is being measured
The primary outcome is the main question the study is designed to answer.
3D soft-tissue changes (linear)
the changes that have occurred in the soft tissue of the face after undergoing orthognathic surgery
Measured: 6 months
Secondary outcomes (4)
Proportion of soft tissue change to hard tissue change
the distance that the soft tissue has moved compared to the underlying bone, as a percentage.
Measured: 6 months
Is the esthetic outcome as expected/imagined?
using a 100mm visual analogue scale the patient will be asked to score how the aesthetic outcome measured against his expectations. 0mm is the worst score where the changes havent met the expectations at all and 100mm is where the outcome has perfectly met the expectation.
Measured: 6 months
3D soft-tissue changes (angular)
the changes that have occurred in the soft tissue of the face after undergoing orthognathic surgery
Measured: 6 months
3D soft-tissue changes (volumetric)
the changes that have occurred in the soft tissue of the face after undergoing orthognathic surgery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study startFeb 2019 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic SurgeryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Moussa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687307
- Sponsor's protocol ID
- cebd-cu-2017-04-05
- Status last verified
- Oct 2018
- First submitted
- 26 Sep 2018
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are the Three Dimensional Soft Tissue Changes That Occur After Orthognathic Surgery for Skeletal Class II Patients? Pre-test Post-test Quasi Experimental Study
- ClinicalTrials.gov ID
- NCT03687307
- Acronym / sponsor ID
- cebd-cu-2017-04-05
- Conditions
- Orthognathic Surgery
- Keywords
- class II,, soft tissue changes, CBCT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2019 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 27 Sep 2018 (actual)
- 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 aim of the study is to establish reference data that could be used for the creation of more accurate three dimensional prediction of soft tissue outcome.
Detailed description
in this study, 15 skeletal class 2 orthognathic patients will be selected. CBCT and proface will be done preoperatively. after the surgery and 6 months later the imaging investigations will be repeated to investigate the soft tissue changes that have resulted due to the bone movement.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients with class 2 skeletal deformity, over 18 years and younger than 40
Key inclusion criteria (3 listed)
- Patients with class II skeletal deformity
- Patients must be over 18 years of age to allow for growth cessation
- Patients must not have any systemic condition which contraindicates general anaesthesia
Key exclusion criteria (4 listed)
- o patients with cleft palate
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
3D soft-tissue changes (linear)
Time frame: 6 months
the changes that have occurred in the soft tissue of the face after undergoing orthognathic surgery
4 secondary outcomes
Proportion of soft tissue change to hard tissue change
Time frame: 6 months
Is the esthetic outcome as expected/imagined?
Time frame: 6 months
3D soft-tissue changes (angular)
Time frame: 6 months
3D soft-tissue changes (volumetric)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthognathic Surgery, run by Cairo University.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Oct 2018. 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?
Results are not available in the source record.
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?
3D soft-tissue changes (linear) (time frame: 6 months). 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 4 Oct 2018.