Maxillofacial AbnormalitiesNCT04895319
Adherence to Computer-assisted Maxillofacial Reconstructions
An observational study of Maxillofacial Abnormalities and Computer-assisted Surgery, run by KU Leuven.
Trial summary
The study was approved by the Local Ethics Committee and was conducted in compliance with the World Medical Association Declaration of Helsinki on medical research. A total of 335 patients who underwent oral and maxillofacial reconstruction were recorded from Jan 2014 to Jun 2020. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Maxillofacial Abnormalities, Computer-assisted Surgery, Virtual Surgical Planning
- What is being tested?
- Computer-assisted surgery
- Type of treatment
- Medical device
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Mar 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 100 years
- All sexes
- Adult, Older adult
Study population: 136 patients who undergone computer-assisted maxillofacial reconstructive surgeries that conducted from June 2014 to June 2020.
Who may be able to join
- Maxillofacial reconstruction with CAS, including virtual surgical planning, CAD-CAM surgical guides/templates and pre-bent plates on 3D printed models.
- Reasons for reconstruction were oncologic, osteoradionecrosis, trauma and osteoporosis.
Who cannot join
- Patients undergoing computer-assisted implant surgery were excluded.
- Patients undergoing computer-assisted orthognathic surgery were excluded.
About this study
Official title: Adherence to Computer-assisted Surgical Planning in 136 Maxillofacial Reconstructions
The study was approved by the Local Ethics Committee and was conducted in compliance with the World Medical Association Declaration of Helsinki on medical research. A total of 335 patients who underwent oral and maxillofacial reconstruction were recorded from Jan 2014 to Jun 2020. Reconstruction with computer-assisted surgery ( CAS), which included, virtual surgical planning, computer-aided design-computer-aided manufacturing (CAD-CAM) surgical guides/templates and pre-bent plates on 3D printed models. Reasons for tissue defect were oncologic, osteoradionecrosis, trauma and osteoporosis. Patients undergoing dental implant placement and orthognathic surgery were excluded. Finally, 136 patients were selected and the reasons for partial or abandon surgical plan performance were described and analyzed.
Read the detailed description
computer-aided design
- Being tested
- Computer-assisted surgery
- Keywords
- Computer-Assisted Surgery, Treatment Adherence and Compliance, Patient-Specific Modelling
- Medical subject headings
- Maxillofacial Abnormalities, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-assisted surgeryDevice
The reconstruction was performed with the help of virtual surgical plan and 3D printed models.
What is being measured
The primary outcome is the main question the study is designed to answer.
The adherence of computer-assisted surgery
The original plans were classified as completely executed, partially executed or abandoned.
Measured: The outcome were recorded preoperatively or intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start1 Jan 2014
- Primary completion1 Jun 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillofacial AbnormalitiesStudies 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongyang Ma, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895319
- Sponsor's protocol ID
- S63615-3
- Status last verified
- May 2021
- First submitted
- 17 May 2021
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Computer-assisted Surgical Planning in 136 Maxillofacial Reconstructions
- ClinicalTrials.gov ID
- NCT04895319
- Acronym / sponsor ID
- S63615-3
- Keywords
- Computer-Assisted Surgery, Treatment Adherence and Compliance, Patient-Specific Modelling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 20 May 2021 (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 study was approved by the Local Ethics Committee and was conducted in compliance with the World Medical Association Declaration of Helsinki on medical research. A total of 335 patients who underwent oral and maxillofacial reconstruction were recorded from Jan 2014 to Jun 2020. Reconstruction with computer-assisted surgery ( CAS), which included, virtual surgical planning, computer-aided design-computer-aided manufacturing (CAD-CAM) surgical guides/templates and pre-bent plates on 3D printed models. Reasons for tissue defect were oncologic, osteoradionecrosis, trauma and osteoporosis. Patients undergoing dental implant placement and orthognathic surgery were excluded. Finally, 136 patients were selected and the reasons for partial or abandon surgical plan performance were described and analyzed.
Detailed description
computer-aided design
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 136 patients who undergone computer-assisted maxillofacial reconstructive surgeries that conducted from June 2014 to June 2020.
Key inclusion criteria (2 listed)
- Maxillofacial reconstruction with CAS, including virtual surgical planning, CAD-CAM surgical guides/templates and pre-bent plates on 3D printed models.
- Reasons for reconstruction were oncologic, osteoradionecrosis, trauma and osteoporosis.
Key exclusion criteria (2 listed)
- Patients undergoing computer-assisted implant surgery were excluded.
- Patients undergoing computer-assisted orthognathic surgery were excluded.
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 |
|---|---|---|
| Computer-assisted surgeryThe reconstruction was performed with the help of virtual surgical plan and 3D printed models. | Device | – |
Primary outcome
The adherence of computer-assisted surgery
Time frame: The outcome were recorded preoperatively or intraoperatively
The original plans were classified as completely executed, partially executed or abandoned.
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 21 May 2021.
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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 Maxillofacial Abnormalities and Computer-assisted Surgery, run by KU Leuven.
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 2 inclusion and 2 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 21 May 2021. 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?
The adherence of computer-assisted surgery (time frame: The outcome were recorded preoperatively or intraoperatively). 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 21 May 2021.