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Clinical Trials/NCT06224478
NCT06224478Not yet recruitingNot Applicable

Assessment of Palatal Mucosal Thickness in Different Vertical Skeletal Pattern: a 3D Analysis

Central Hospital, Nancy, France0 sites100 target enrollmentStarted: January 25, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
100
Primary Endpoint
Palatal mucosa thickness

Study Overview

Brief Summary

This study assesses the potential statistical correlation between vertical facial pattern and palatal mucosa thickness.

Data collection : dicom files (CBCT) merged with STL files of n patients for soft tissue visualization

Aim: to volumetrically assess (with CBCT) the palatal mucosa thickness in different vertical facial types to aid clinicians in the planning and placement of orthodontic miniscrews.

Hypothesis : There is no significant difference between the 3 groups studied (i.e. no correlation between palatal mucosa thickness and vertical facial typology).

Detailed Description

Study rationale : The use of palatal miniscrew offers the possibility to improve the effectiveness of orthodontic expansion devices. Palatal expanders supported by miniscrew can be applied with different clinical protocols. The palatal mucosa thickness affects the choice of miniscrew length.

Justification for overlaying on STL files: When the lingual dorsum and palatal mucosa are in mutual contact during CBCT examination, it is not possible to distinguish one from the other during subsequent imaging evaluation. Various methods have been proposed to overcome these limitations, including the superimposition of the dicom and stl files: this methodology enables the profile of the palatal mucosa to be distinctly identified in all the analyzed scans.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Full permanent dentition (except for third molar)
  • Normal craniofacial development
  • Aged > 16 years
  • Complete skeletal maturity (assessed by the cervical vertebral maturation method)
  • Absence of previous orthodontic or orthognatic surgical treatment

Exclusion Criteria

  • Absence of any tooth other than the third molar
  • Maxillary impacted tooth
  • CBCT scans taken without teeth in occlusion/open bite
  • Distorting pathologies of the facial mass affecting the palatal zone
  • Periodontal or endodontic diseases affecting the bone
  • Presence of metallic artifact
  • History of previous orthognatic or orthodontic surgeries

Outcomes

Primary Outcomes

Palatal mucosa thickness

Time Frame: Baseline

In milimetres

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Central Hospital, Nancy, France
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

VANDE VANNET Bart

Head of the University Department of Dentofacial Orthopedics, University of Lorraine, Nancy

Central Hospital, Nancy, France

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