NCT04041388

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 16, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

July 31, 2019

Last Update Submit

August 13, 2019

Conditions

Maxillary Hypoplasia

Keywords

TranspalatalMaxillary expansionTooth-borneBone-borneDistractorTippingOsteotomy height

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Tooth tipping

OTHER
Other: Conebeam CT

Interventions

Conebeam CTOTHER

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

Tooth tipping

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Vlaams Brabant, 1090, Belgium

Location

MeSH Terms

Conditions

Retrognathia

Condition Hierarchy (Ancestors)

Jaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesMandibular DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Wendy Van Bogaert, MD

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

  • Maurice Mommaerts, Prof MULT

    Universitair Ziekenhuis Brussel

    STUDY DIRECTOR

  • Nathalie Loomans, MD

    GasthuisZusters Antwerpen (GZA)

    STUDY CHAIR

  • Yannick Spaey, MD

    Mariaziekenhuis Noord-Limburg

    STUDY CHAIR

Central Study Contacts

Veerle Van Mossevelde, SC

CONTACT

+3224763134veerle.vanmossevelde@uzbrussel.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Coordinator

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 1, 2019

Study Start

September 1, 2019

Primary Completion

September 1, 2020

Study Completion

December 31, 2020

Last Updated

August 16, 2019

Record last verified: 2019-08

Locations

BE(1)