Maxillary HypoplasiaNCT04041388
Maxillary Segment Tipping During Transpalatal Distraction
A study testing Conebeam CT in people with Maxillary Hypoplasia, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The investigator proposes a multi-centre study to investigate tipping of teeth, bringing into consideration the height of the osteotomy line and the height and placement of the transpalatal distractor as possible factors. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Maxillary Hypoplasia
- What is being tested?
- Conebeam CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2019to 31 Dec 2020
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Undergoing a surgically assisted rapid maxillary expansion with a bone borne transpalatal distractor.
- Cone beam CT pre op and 3 weeks post op is available
Who cannot join
- Complication of the process by e.g. surgical site infection
- Asymmetrical expansion of more than 3.0 mm measured at the central incisivae occurred
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Maxillary Segment Tipping During Transpalatal Distraction Related to the Vertical Level of the Horizontal Corticotomies and the Vertical Position of the Distractor Related to Dental and Bony Reference Planes?
The investigator proposes a multi-centre study to investigate tipping of teeth, bringing into consideration the height of the osteotomy line and the height and placement of the transpalatal distractor as possible factors. If tipping occurs depending on these factors, the investigator could identify the situations that cannot be straightened by the orthodontist and provide another course of action for these specific patients.
Read the detailed description
Surgically Assisted Rapid Maxillary Expansion (SARME) is widely accepted for the treatment of maxillary hypoplasia. The differences between SARME with a tooth-borne or a bone-borne distractor have already been extensively investigated, bringing to light that a bone-borne distractor has less negative side effects. One of the major concerns with the tooth-borne distractor is the tipping of the anchor teeth, which is bypassed by the bone-borne distractor which applies its force directly on the bone. One study investigated the tipping of teeth with a bone-borne distractor in 10 patients, showing that there was a minor change in the tooth axis. The investigator proposes a multi-center study to investigate this tipping further, bringing into consideration the height of the osteotomy line and the height and placement of the transpalatal distractor as possible factors. If tipping occurs depending on these factors, the investigator could identify the situations that cannot be straightened by the orthodontist and provide another course of action for these specific patients.
- Conditions
- Maxillary Hypoplasia
- Being tested
- Conebeam CT
- Keywords
- Transpalatal, Maxillary expansion, Tooth-borne, Bone-borne, Distractor, Tipping, Osteotomy height
- Medical subject headings
- Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conebeam CTOther
medical imaging technique consisting of X-ray computed tomography where the X-rays are divergent, forming a cone
| Study group | Role | What they receive |
|---|---|---|
| Tooth tipping | Other | Not described Receives: Other: Conebeam CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth axis
To investigate changes in the tooth axis of the first and second (pre-)molars bilaterally in the upper jaw before and after surgically assisted rapid maxillary expansion using a bone borne transpalatal distractor.
Measured: 3 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary HypoplasiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veerle Van Mossevelde, Universitair Ziekenhuis Brussel
- Investigators
- Wendy Van Bogaert, MD, Principal investigator, Universitair Ziekenhuis BrusselMaurice Mommaerts, Prof MULT, Study director, Universitair Ziekenhuis BrusselNathalie Loomans, MD, Study chair, GasthuisZusters Antwerpen (GZA)Yannick Spaey, MD, Study chair, Mariaziekenhuis Noord-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041388
- Sponsor's protocol ID
- TPD Studie v 1.0
- Status last verified
- Aug 2019
- First submitted
- 31 Jul 2019
- Last updated
- 16 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Maxillary Segment Tipping During Transpalatal Distraction Related to the Vertical Level of the Horizontal Corticotomies and the Vertical Position of the Distractor Related to Dental and Bony Reference Planes?
- ClinicalTrials.gov ID
- NCT04041388
- Acronym / sponsor ID
- TPD Studie v 1.0
- Conditions
- Maxillary Hypoplasia
- Keywords
- Transpalatal, Maxillary expansion, Tooth-borne, Bone-borne, Distractor, Tipping, Osteotomy height
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 1 Aug 2019 (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 investigator proposes a multi-centre study to investigate tipping of teeth, bringing into consideration the height of the osteotomy line and the height and placement of the transpalatal distractor as possible factors. If tipping occurs depending on these factors, the investigator could identify the situations that cannot be straightened by the orthodontist and provide another course of action for these specific patients.
Detailed description
Surgically Assisted Rapid Maxillary Expansion (SARME) is widely accepted for the treatment of maxillary hypoplasia. The differences between SARME with a tooth-borne or a bone-borne distractor have already been extensively investigated, bringing to light that a bone-borne distractor has less negative side effects. One of the major concerns with the tooth-borne distractor is the tipping of the anchor teeth, which is bypassed by the bone-borne distractor which applies its force directly on the bone. One study investigated the tipping of teeth with a bone-borne distractor in 10 patients, showing that there was a minor change in the tooth axis. The investigator proposes a multi-center study to investigate this tipping further, bringing into consideration the height of the osteotomy line and the height and placement of the transpalatal distractor as possible factors. If tipping occurs depending on these factors, the investigator could identify the situations that cannot be straightened by the orthodontist and provide another course of action for these specific patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tooth tipping | Other | Other: Conebeam CT |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing a surgically assisted rapid maxillary expansion with a bone borne transpalatal distractor.
- Cone beam CT pre op and 3 weeks post op is available
Key exclusion criteria (2 listed)
- Complication of the process by e.g. surgical site infection
- Asymmetrical expansion of more than 3.0 mm measured at the central incisivae occurred
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 |
|---|---|---|
| Conebeam CTmedical imaging technique consisting of X-ray computed tomography where the X-rays are divergent, forming a cone | Other | Tooth tipping |
Primary outcome
Tooth axis
Time frame: 3 weeks postoperatively
To investigate changes in the tooth axis of the first and second (pre-)molars bilaterally in the upper jaw before and after surgically assisted rapid maxillary expansion using a bone borne transpalatal distractor.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
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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.
Wendy Van Bogaert, MD principal investigator
Universitair Ziekenhuis Brussel
Maurice Mommaerts, Prof MULT study director
Universitair Ziekenhuis Brussel
Nathalie Loomans, MD study chair
GasthuisZusters Antwerpen (GZA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conebeam CT in people with Maxillary Hypoplasia, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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: status not confirmed, as of the sponsor's last update on 16 Aug 2019. 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 Belgium. 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 Veerle Van Mossevelde, SC (+3224763134, veerle.vanmossevelde@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tooth axis (time frame: 3 weeks postoperatively). 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 16 Aug 2019.