Maxillofacial AbnormalitiesSASCWatchNCT06183853
Evaluation of the Long-term Results of Extended Supra-basillary Genioplasty of the "Chin Wing" Type Without Bone Graft
An observational study of Maxillofacial Abnormalities, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The correction of maxillomandibular dysmorphoses, responsible for both functional discomfort (lip incompetence, ventilation disorders, periodontal disease) but also aesthetic, calls in particular for genioplasty, of which there are several techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maxillofacial Abnormalities
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2022to 5 Jun 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Major subject (≥ 18 years old) having undergone "Chin Wing" type genioplasty surgery in the maxillofacial surgery department of Strasbourg between October 1, 2012 and June 30, 2022.
Who may be able to join
- Major subject (≥ 18 years old)
- having undergone "Chin Wing" type genioplasty surgery in the maxillofacial surgery department of Strasbourg between October 1, 2012 and June 30, 2022.
- Subject who has not expressed his opposition to the reuse of his data for scientific research purposes.
Who cannot join
- Subject having expressed their opposition to the reuse of their data for scientific research purposes
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Plastique, Reconstructrice, Esthétique et Maxillo-faciale - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Official title: Evaluation of the Long-term Results of Extended Supra-basillary Genioplasty of the "Chin Wing" Type Without Bone Graft: Aesthetic and Functional Satisfaction, Sensory Recovery and Bone Healing
The correction of maxillomandibular dysmorphoses, responsible for both functional discomfort (lip incompetence, ventilation disorders, periodontal disease) but also aesthetic, calls in particular for genioplasty, of which there are several techniques. One of these chin repositioning techniques, called "Chin Wing", cuts the bone to optimize the functional and aesthetic result. While all genioplasty techniques expose the risk of nerve damage and lack of bone consolidation, these parameters are only rarely addressed in the literature in the specific context of this extensive bone cutting.
The objective of this work is to assess the satisfaction of patients who have benefited from chin advancement surgery using the "Chin Wing" technique.
- Conditions
- Maxillofacial Abnormalities
- Keywords
- Dysmorphoses, Maxillofacial Abnormalities, Maxillomandibular, Lip incompetence, Ventilation disorders, Genioplasty
- Medical subject headings
- Maxillofacial Abnormalities
What is being measured
The primary outcome is the main question the study is designed to answer.
Aesthetic and functional satisfaction of the patients' results of surgery
Aesthetic and functional satisfaction of the patients who have benefited from chin advancement surgery using the "Chin Wing" technique.
This satisfaction is assessed by a satisfaction questionnaire of 10 questions. Single answer out of 4 items proposed per question.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start5 Sep 2022
- Primary completion5 Jun 2023
- Study completion5 Jun 2023
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.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Other
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183853
- Sponsor's protocol ID
- 8702
- Acronym
- SASCWatch
- Status last verified
- Dec 2023
- First submitted
- 14 Sep 2022
- Last updated
- 20 Aug 2024
- 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 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Long-term Results of Extended Supra-basillary Genioplasty of the "Chin Wing" Type Without Bone Graft: Aesthetic and Functional Satisfaction, Sensory Recovery and Bone Healing
- ClinicalTrials.gov ID
- NCT06183853
- Acronym / sponsor ID
- SASCWatch / 8702
- Conditions
- Maxillofacial Abnormalities
- Keywords
- Dysmorphoses, Maxillofacial Abnormalities, Maxillomandibular, Lip incompetence, Ventilation disorders, Genioplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 28 Dec 2023 (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 correction of maxillomandibular dysmorphoses, responsible for both functional discomfort (lip incompetence, ventilation disorders, periodontal disease) but also aesthetic, calls in particular for genioplasty, of which there are several techniques. One of these chin repositioning techniques, called "Chin Wing", cuts the bone to optimize the functional and aesthetic result. While all genioplasty techniques expose the risk of nerve damage and lack of bone consolidation, these parameters are only rarely addressed in the literature in the specific context of this extensive bone cutting.
The objective of this work is to assess the satisfaction of patients who have benefited from chin advancement surgery using the "Chin Wing" technique.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major subject (≥ 18 years old) having undergone "Chin Wing" type genioplasty surgery in the maxillofacial surgery department of Strasbourg between October 1, 2012 and June 30, 2022.
Key inclusion criteria (3 listed)
- Major subject (≥ 18 years old)
- having undergone "Chin Wing" type genioplasty surgery in the maxillofacial surgery department of Strasbourg between October 1, 2012 and June 30, 2022.
- Subject who has not expressed his opposition to the reuse of his data for scientific research purposes.
Key exclusion criteria (1 listed)
- Subject having expressed their opposition to the reuse of their data for scientific research purposes
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
Aesthetic and functional satisfaction of the patients' results of surgery
Time frame: 6 months after surgery
Aesthetic and functional satisfaction of the patients who have benefited from chin advancement surgery using the "Chin Wing" technique. This satisfaction is assessed by a satisfaction questionnaire of 10 questions. Single answer out of 4 items proposed per question.
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 20 Aug 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maxillofacial Abnormalities, run by University Hospital, Strasbourg, France at 1 site in France.
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 1 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 20 Aug 2024. 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 France. 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?
Aesthetic and functional satisfaction of the patients' results of surgery (time frame: 6 months after surgery). 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 20 Aug 2024.