Dental DeformityNCT07511296
Orthognathic Surgery With Clear Aligners vs Conventional Brackets
An observational study of Dental Deformity and Malocclusion, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
This retrospective single-center observational study compared perioperative and early postoperative outcomes in patients undergoing orthognathic surgery after orthodontic preparation with either conventional fixed brackets or clear aligners. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Dental Deformity, Malocclusion, Orthognathic Surgery
- What is being tested?
- Conventional fixed orthodontic appliances and Clear aligner therapy
- Type of treatment
- Medical device
- How many people
- 420 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 3 Sep 2025
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients treated for dentofacial deformities requiring orthognathic surgery at a single tertiary referral center in France.
Who may be able to join
- Patients undergoing orthognathic surgery at the study center during the study period.
- Orthodontic preparation with either conventional fixed brackets or clear aligners.
- Age 16 years or older.
- Available perioperative clinical records and required imaging data.
Who cannot join
- Missing perioperative data required for the analysis.
- Missing preoperative or postoperative imaging required for assessment.
- Explicit opposition to the reuse of data, if applicable.
- Syndromic conditions.
- Cleft-related deformities.
- Distraction osteogenesis.
- Secondary surgery.
- Follow-up < 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Outcomes in Orthognathic Surgery With Clear Aligners Versus Conventional Brackets: A Retrospective Comparative Study
This retrospective single-center observational study compared perioperative and early postoperative outcomes in patients undergoing orthognathic surgery after orthodontic preparation with either conventional fixed brackets or clear aligners. The objective was to assess whether aligner-based preparation was associated with differences in intraoperative occlusal management, including fixation stability, technical difficulties, need for additional intraoperative adaptations, and early occlusal outcomes.
- Conditions
- Dental Deformity, Malocclusion, Orthognathic Surgery
- Being tested
- Conventional fixed orthodontic appliances, Clear aligner therapy
- Medical subject headings
- Tooth Abnormalities, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional fixed orthodontic appliancesDevice
Orthodontic preparation with fixed multi-bracket appliances in place at the time of surgery, providing conventional anchorage for intermaxillary fixation and intraoperative occlusal control.
Clear aligner therapyDevice
Orthodontic preparation with clear aligners and no fixed brackets at the time of surgery. Alternative intraoperative strategies may be required to achieve planned occlusal positioning and stabilization.
| Study group | Role | What they receive |
|---|---|---|
| Conventional brackets group | Not described Receives: Device: Conventional fixed orthodontic appliances | |
| Clear aligners group | Not described Receives: Device: Clear aligner therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite perioperative occlusal management event
Number of composite perioperative occlusal management event for each patient
Measured: From surgery to the immediate postoperative assessment
Secondary outcomes (2)
Stable intermaxillary fixation
Number of stable intermaxilary fixation or not for each patient
Measured: From begining to the end of the surgery
Surgical revision after surgery
Number of patient with postoperative complications 6 months after surgery
Measured: After surgery and the next 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 Jan 2020
- Primary completion3 Sep 2025
- Study completion3 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511296
- Sponsor's protocol ID
- 26IUFC02
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 6 Apr 2026
- 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Outcomes in Orthognathic Surgery With Clear Aligners Versus Conventional Brackets: A Retrospective Comparative Study
- ClinicalTrials.gov ID
- NCT07511296
- Acronym / sponsor ID
- 26IUFC02
- Conditions
- Dental Deformity, Malocclusion, Orthognathic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 6 Apr 2026 (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.
This retrospective single-center observational study compared perioperative and early postoperative outcomes in patients undergoing orthognathic surgery after orthodontic preparation with either conventional fixed brackets or clear aligners. The objective was to assess whether aligner-based preparation was associated with differences in intraoperative occlusal management, including fixation stability, technical difficulties, need for additional intraoperative adaptations, and early occlusal outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional brackets group | – | Device: Conventional fixed orthodontic appliances |
| Clear aligners group | – | Device: Clear aligner therapy |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients treated for dentofacial deformities requiring orthognathic surgery at a single tertiary referral center in France.
Key inclusion criteria (4 listed)
- Patients undergoing orthognathic surgery at the study center during the study period.
- Orthodontic preparation with either conventional fixed brackets or clear aligners.
- Age 16 years or older.
- Available perioperative clinical records and required imaging data.
Key exclusion criteria (8 listed)
- Missing perioperative data required for the analysis.
- Missing preoperative or postoperative imaging required for assessment.
- Explicit opposition to the reuse of data, if applicable.
- Syndromic conditions.
- Cleft-related deformities.
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 |
|---|---|---|
| Conventional fixed orthodontic appliancesOrthodontic preparation with fixed multi-bracket appliances in place at the time of surgery, providing conventional anchorage for intermaxillary fixation and intraoperative occlusal control. | Device | Conventional brackets group |
| Clear aligner therapyOrthodontic preparation with clear aligners and no fixed brackets at the time of surgery. Alternative intraoperative strategies may be required to achieve planned occlusal positioning and stabilization. | Device | Clear aligners group |
Primary outcome
Composite perioperative occlusal management event
Time frame: From surgery to the immediate postoperative assessment
Number of composite perioperative occlusal management event for each patient
2 secondary outcomes
Stable intermaxillary fixation
Time frame: From begining to the end of the surgery
Surgical revision after surgery
Time frame: After surgery and the next 6 months
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 6 Apr 2026.
Related trials for Dental Deformity
Recruiting
Dental Implant Healing With TNF-Alpha Inhibitors
Dental Implants, TNF-alpha Inhibitors
Not yet recruiting
Esthetic Impact of Different Minimally Invasive Approaches on Hypomineralized Permanent Anterior Teeth
Enamel Hypomineralization, Dental
Not yet recruiting
Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in MIH-Affected Permanent First Molars
Molar-Incisor Hypomineralization (MIH)
Recruiting
Nanohydroxyapatite Versus Sodium Fluoride Varnish in Remineralizing MIH Anterior Teeth
Fluoride Varnishes, Molar Incisor Hypomineralisation
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
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 Dental Deformity and Malocclusion, run by Centre Hospitalier Universitaire de Nice 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 4 inclusion and 8 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 6 Apr 2026. 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?
Composite perioperative occlusal management event (time frame: From surgery to the immediate postoperative assessment). 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 6 Apr 2026.