Maxilla; HypoplasiaNCT03511989
Transverse Maxillary Expansion With a Segmental Le Fort I Osteotomy or Surgically Assisted Rapid Maxillary Expansion (SARME)
A study testing Bone borne distractor, Tooth borne distractor and Segmental LF1 Osteotomy group 1 in people with Maxilla; Hypoplasia, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
To assess transverse dental and skeletal expansion and stability after SLFIO with no fixation of the palatal vault compared to stabilization of the palatal vault with an autogenous bone block graft or fixation of the palatal osteotomy site with a biodegradable plate. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Maxilla; Hypoplasia
- What is being tested?
- Bone borne distractor, Tooth borne distractor and Segmental LF1 Osteotomy group 1
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2016to 1 Aug 2025
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mature non-syndromic patients scheduled for transverse expansion of the maxilla
Who cannot join
- Previous orthognathic surgery involving the maxilla Congenital maxillofacial deformities
Trial locations and contacts
1 site in 1 country.
Tue L Blæhr, DDS contact
Thomas Starch-jensen, DDS contact
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, 9000
Tue L Blæhr, DDS, t.blaehr@rn.dk
About this study
To assess transverse dental and skeletal expansion and stability after SLFIO with no fixation of the palatal vault compared to stabilization of the palatal vault with an autogenous bone block graft or fixation of the palatal osteotomy site with a biodegradable plate.
To assess transverse maxillary dental and skeletal expansion and stability after SARME with a TB distraction appliance compared to a BB distraction appliance.
Read the detailed description
Background: Surgical correction of transverse maxillary hypoplasia, in adolescents and adults is considered the least stable orthognathic procedure. Different surgical techniques have been advocated to improve the transverse stability. However, the pattern of transverse dental and skeletal expansion and long-term stability after segmental Le Fort I osteotomy (SLFIO) and surgically assisted rapid maxillary expansion (SARME) have never been compared systematically with different fixation techniques or distraction appliances.
Purpose: Test the H0-hypothesis of no difference in transverse stability after SLFIO without fixation of the palatal vault compared to stabilizing with either a bone block graft or a biodegradable plate. Moreover, test the H0-hypothesis of no difference in transverse maxillary dental and skeletal expansion and stability after SARME with either a tooth-borne (TB) or a bone-borne (BB) distraction appliance.
Method: 60 patients scheduled for SLFIO are included in a randomized clinical trial and allocated into 3 groups; I) stabilization of the palatal vault with a bone block graft, II) fixation of the palatal vault with a biodegradable plate and III) no fixation of the palatal vault. Moreover, 30 patients undergoing SARME are randomly allocated to either a TB or a BB distraction appliance. Transverse expansion and stability is assessed by clinical and radiographic measurements evaluating differences between dental and skeletal expansion, the pattern of skeletal expansion and the long-term stability.
Primary impact goal: Long-term transverse maxillary stability after SLFIO and SARME.
- Conditions
- Maxilla; Hypoplasia
- Being tested
- Bone borne distractor, Tooth borne distractor, Segmental LF1 Osteotomy group 1, Segmental LF1 Osteotomy group 2, Segmental LF1 Osteotomy group 3
- Medical subject headings
- Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone borne distractorDevice
Bone borne distraction device
Tooth borne distractorDevice
Tooth borne distraction device
Segmental LF1 Osteotomy group 1Procedure or surgery
Segmental LF1 Osteotomy group 2Procedure or surgery
Segmental LF1 Osteotomy group 3Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Bone Borne distractor | Active comparator | The device being investigated, Boneborne distraction appliance Receives: Device: Bone borne distractor |
| Tooth borne distractor | Other | The control device Toothborne distraction appliance Receives: Device: Tooth borne distractor |
| Segmental LF1 osteotomy group 1 | No intervention | Control Group, no stabilization of palatal vault |
| Segmental LF1 osteotomy group 2 | Active comparator | Testgroup, biodegradable plate at osteotomy site in palate Receives: Procedure: Segmental LF1 Osteotomy group 1; Procedure: Segmental LF1 Osteotomy group 3 |
| Segmental LF1 osteotomy group 3 | Active comparator | Testgroup, autologous bonegraft at palatal osteotomy site Receives: Procedure: Segmental LF1 Osteotomy group 1; Procedure: Segmental LF1 Osteotomy group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal relapse
Relapse in milimeters
Measured: 2 years
Secondary outcomes (1)
Dental relapse
Relapse in milimeters
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start1 Aug 2016
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxilla; HypoplasiaStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tue Lindberg Blæhr, Aalborg University Hospital
- Investigators
- Tue Blæhr, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511989
- Sponsor's protocol ID
- N-20160057
- Status last verified
- Jan 2020
- First submitted
- 26 Oct 2017
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transverse Maxillary Expansion With a Segmental Le Fort I Osteotomy or Surgically Assisted Rapid Maxillary Expansion (SARME)
- ClinicalTrials.gov ID
- NCT03511989
- Acronym / sponsor ID
- N-20160057
- Conditions
- Maxilla; Hypoplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 30 Apr 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.
To assess transverse dental and skeletal expansion and stability after SLFIO with no fixation of the palatal vault compared to stabilization of the palatal vault with an autogenous bone block graft or fixation of the palatal osteotomy site with a biodegradable plate.
To assess transverse maxillary dental and skeletal expansion and stability after SARME with a TB distraction appliance compared to a BB distraction appliance.
Detailed description
Background: Surgical correction of transverse maxillary hypoplasia, in adolescents and adults is considered the least stable orthognathic procedure. Different surgical techniques have been advocated to improve the transverse stability. However, the pattern of transverse dental and skeletal expansion and long-term stability after segmental Le Fort I osteotomy (SLFIO) and surgically assisted rapid maxillary expansion (SARME) have never been compared systematically with different fixation techniques or distraction appliances.
Purpose: Test the H0-hypothesis of no difference in transverse stability after SLFIO without fixation of the palatal vault compared to stabilizing with either a bone block graft or a biodegradable plate. Moreover, test the H0-hypothesis of no difference in transverse maxillary dental and skeletal expansion and stability after SARME with either a tooth-borne (TB) or a bone-borne (BB) distraction appliance.
Method: 60 patients scheduled for SLFIO are included in a randomized clinical trial and allocated into 3 groups; I) stabilization of the palatal vault with a bone block graft, II) fixation of the palatal vault with a biodegradable plate and III) no fixation of the palatal vault. Moreover, 30 patients undergoing SARME are randomly allocated to either a TB or a BB distraction appliance. Transverse expansion and stability is assessed by clinical and radiographic measurements evaluating differences between dental and skeletal expansion, the pattern of skeletal expansion and the long-term stability.
Primary impact goal: Long-term transverse maxillary stability after SLFIO and SARME.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Bone Borne distractor | Active comparator | Device: Bone borne distractorThe device being investigated, Boneborne distraction appliance |
| Tooth borne distractor | Other | Device: Tooth borne distractorThe control device Toothborne distraction appliance |
| Segmental LF1 osteotomy group 1 | No intervention | –Control Group, no stabilization of palatal vault |
| Segmental LF1 osteotomy group 2 | Active comparator | Procedure: Segmental LF1 Osteotomy group 1, Procedure: Segmental LF1 Osteotomy group 3Testgroup, biodegradable plate at osteotomy site in palate |
| Segmental LF1 osteotomy group 3 | Active comparator | Procedure: Segmental LF1 Osteotomy group 1, Procedure: Segmental LF1 Osteotomy group 2Testgroup, autologous bonegraft at palatal osteotomy site |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Mature non-syndromic patients scheduled for transverse expansion of the maxilla
Key exclusion criteria (1 listed)
- Previous orthognathic surgery involving the maxilla Congenital maxillofacial 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 |
|---|---|---|
| Bone borne distractorBone borne distraction device | Device | Bone Borne distractor |
| Tooth borne distractorTooth borne distraction device | Device | Tooth borne distractor |
| Segmental LF1 Osteotomy group 1 | Procedure or surgery | Segmental LF1 osteotomy group 2, Segmental LF1 osteotomy group 3 |
| Segmental LF1 Osteotomy group 2 | Procedure or surgery | Segmental LF1 osteotomy group 3 |
| Segmental LF1 Osteotomy group 3 | Procedure or surgery | Segmental LF1 osteotomy group 2 |
Primary outcome
Skeletal relapse
Time frame: 2 years
Relapse in milimeters
1 secondary outcome
Dental relapse
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Tue L Blæhr, DDS contact
Thomas Starch-jensen, DDS contact
Tue Blæhr principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone borne distractor, Tooth borne distractor and Segmental LF1 Osteotomy group 1 in people with Maxilla; Hypoplasia, run by Aalborg University Hospital at 1 site in Denmark.
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 1 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: status not confirmed, as of the sponsor's last update on 9 Jan 2020. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tue L Blæhr, DDS (t.blaehr@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal relapse (time frame: 2 years). 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 9 Jan 2020.