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

January 16, 2024 updated by: VANDE VANNET Bart, Central Hospital, Nancy, France

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients who have undergone CBCT at Nancy University Hospital, Boston University and in private practice

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hypodivergent
Other: Measurement of palatal mucosa thickness on CBCT scans
Measurement of palatal mucosa thickness on CBCT scans in hypodovergent, normodivergent and hyperdivergent patients
Normodivergent
Other: Measurement of palatal mucosa thickness on CBCT scans
Measurement of palatal mucosa thickness on CBCT scans in hypodovergent, normodivergent and hyperdivergent patients
Hyperdivergent
Other: Measurement of palatal mucosa thickness on CBCT scans
Measurement of palatal mucosa thickness on CBCT scans in hypodovergent, normodivergent and hyperdivergent patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Palatal mucosa thickness
Time Frame: Baseline
In milimetres
Baseline

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

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 (Estimated)

January 25, 2024

Primary Completion (Estimated)

March 15, 2024

Study Completion (Estimated)

April 15, 2024

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2023PI218

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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