Maxillary Segment Tipping During Transpalatal Distraction

August 13, 2019 updated by: Veerle Van Mossevelde, Universitair Ziekenhuis Brussel

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Vlaams Brabant
      • Jette, Vlaams Brabant, Belgium, 1090
        • Universitair Ziekenhuis Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Tooth tipping
Other: Conebeam CT
medical imaging technique consisting of X-ray computed tomography where the X-rays are divergent, forming a cone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Wendy Van Bogaert, MD, Universitair Ziekenhuis Brussel
  • Study Chair: Nathalie Loomans, MD, GasthuisZusters Antwerpen (GZA)
  • Study Chair: Yannick Spaey, MD, Mariaziekenhuis Noord-Limburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

July 31, 2019

First Submitted That Met QC Criteria

July 31, 2019

First Posted (Actual)

August 1, 2019

Study Record Updates

Last Update Posted (Actual)

August 16, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TPD Studie v 1.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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