Maxillary Segment Tipping During Transpalatal Distraction

Maxillary Hypoplasia Clinical Trial

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?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04041388
• Other study ID #: TPD Studie v 1.0
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2019
• Source: Universitair Ziekenhuis Brussel
• Contact: Veerle Van Mossevelde, SC
• Phone: +3224763134
• Email: veerle.vanmossevelde[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Maxillary Hypoplasia
• Micrognathism

Intervention

Other:
• Conebeam CT
medical imaging technique consisting of X-ray computed tomography where the X-rays are divergent, forming a cone

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 weeks postoperatively