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

NCT ID: NCT06224478

Last Updated: 2024-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-25

Study Completion Date

2024-04-15

Brief Summary

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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

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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.

Conditions

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Palatal Mucosa Thickness

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Hypodivergent

Measurement of palatal mucosa thickness on CBCT scans

Intervention Type OTHER

Measurement of palatal mucosa thickness on CBCT scans in hypodovergent, normodivergent and hyperdivergent patients

Normodivergent

Measurement of palatal mucosa thickness on CBCT scans

Intervention Type OTHER

Measurement of palatal mucosa thickness on CBCT scans in hypodovergent, normodivergent and hyperdivergent patients

Hyperdivergent

Measurement of palatal mucosa thickness on CBCT scans

Intervention Type OTHER

Measurement of palatal mucosa thickness on CBCT scans in hypodovergent, normodivergent and hyperdivergent patients

Interventions

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Measurement of palatal mucosa thickness on CBCT scans

Measurement of palatal mucosa thickness on CBCT scans in hypodovergent, normodivergent and hyperdivergent patients

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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VANDE VANNET Bart

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2023PI218

Identifier Type: -

Identifier Source: org_study_id

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