Clinical trial NCT04041388: Maxillary Segment Tipping During Transpalatal Distraction
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?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maxillary Hypoplasia
Keywords: Transpalatal
Maxillary expansion
Tooth-borne
Bone-borne
Distractor
Tipping
Osteotomy height
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tooth axis
timeFrame: 3 weeks postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Vlaams Brabant
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Wendy Van Bogaert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Maurice Mommaerts, Prof MULT
role: STUDY_DIRECTOR
affiliation: GasthuisZusters Antwerpen (GZA)
name: Nathalie Loomans, MD
role: STUDY_CHAIR
affiliation: Mariaziekenhuis Noord-Limburg
name: Yannick Spaey, MD
role: STUDY_CHAIR
References: