Maxillary Segment Tipping During Transpalatal Distraction

NCT ID: NCT04041388

Last Updated: 2019-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-12-31

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.

Conditions

Maxillary Hypoplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tooth tipping

Group Type: OTHER

Conebeam CT

Intervention Type: OTHER

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

Interventions

Conebeam CT

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Veerle Van Mossevelde

Study Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wendy Van Bogaert, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Maurice Mommaerts, Prof MULT

Role: STUDY_DIRECTOR

Universitair Ziekenhuis Brussel

Nathalie Loomans, MD

Role: STUDY_CHAIR

GasthuisZusters Antwerpen (GZA)

Yannick Spaey, MD

Role: STUDY_CHAIR

Mariaziekenhuis Noord-Limburg

Locations

Universitair Ziekenhuis Brussel

Jette, Vlaams Brabant, Belgium

Countries

Belgium

Central Contacts

Veerle Van Mossevelde, SC

Role: CONTACT

veerle.vanmossevelde@uzbrussel.be

+3224763134

Other Identifiers

TPD Studie v 1.0

Identifier Type: -

Identifier Source: org_study_id