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Maxillary Segment Tipping During Transpalatal Distraction

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?

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04041388
Enrollment
200
Registered
2019-08-01
Start date
2019-09-01
Completion date
2020-12-31
Last updated
2019-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Hypoplasia

Keywords

Transpalatal, Maxillary expansion, Tooth-borne, Bone-borne, Distractor, Tipping, Osteotomy height

Brief 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. 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.

Interventions

medical imaging technique consisting of X-ray computed tomography where the X-rays are divergent, forming a cone

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Complication of the process by e.g. surgical site infection * Asymmetrical expansion of more than 3.0 mm measured at the central incisivae occurred

Design outcomes

Primary

MeasureTime frameDescription
Tooth axis3 weeks postoperativelyTo 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.

Countries

Belgium

Contacts

Primary ContactVeerle Van Mossevelde, SC
veerle.vanmossevelde@uzbrussel.be+3224763134

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026