Assessment of Palatal Mucosal Thickness in Different Vert... | NCT06224478

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

NCT06224478

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Jan 25, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Palatal Mucosa Thickness

Interventions

Measurement of palatal mucosa thickness on CBCT scans

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 25, 2024Estimated

Primary Completion Date

Mar 15, 2024Estimated

Completion Date

Apr 15, 2024Estimated

First Submitted Date

Jan 16, 2024

First Submission Date that Met QC Criteria

Jan 16, 2024

First Posted Date

Jan 25, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2024

Last Update Posted Date

Jan 25, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

VANDE VANNET Bart, Head of the University Department of Dentofacial Orthopedics, University of Lorraine, Nancy, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypodivergent			Other: Measurement of palatal mucosa thickness on CBCT scans
Normodivergent			Other: Measurement of palatal mucosa thickness on CBCT scans
Hyperdivergent			Other: Measurement of palatal mucosa thickness on CBCT scans

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Measurement of palatal mucosa thickness on CBCT scans	Other	Measurement of palatal mucosa thickness on CBCT scans in hypodovergent, normodivergent and hyperdivergent patients	Hyperdivergent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Palatal mucosa thickness	In milimetres	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample