Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT06246656
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2023-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Hard and Soft Tissue Change During Maxillary Expansion Using a Computer-aided Design / Computer-aided Manufacturing Appliance.
Sponsor:
Medical University of Vienna
Organization:
Study Overview
Official Title:
Hard and Soft Tissue Changes During Maxillary Expansion Using Skeletally Anchored Appliances: a Prospective, Randomized Clinical Study.
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
* Hard tissue changes during the transversal expansion of the maxilla using a CAD/CAM expansion appliance.
* Soft tissue changes during the transversal expansion of the maxilla using a CAD/CAM expansion appliance.
Participants will undergo orthodontic treatment, including:
* Initial records (intraoral scan, CBCT (cone-beam computed tomography) scan, face scan)
* Placement of guided orthodontic TADs (Temporary Anchorage Devices)
* Skeletal expansion using CAD/CAM appliance
* Fixed multibracket appliance in the upper and lower jaw
* Intermediate and terminal documents (intraoral scan, CBCT scan, face scan)
* Soft tissue changes during the transversal expansion of the maxilla using a CAD/CAM expansion appliance.
Participants will undergo orthodontic treatment, including:
* Initial records (intraoral scan, CBCT (cone-beam computed tomography) scan, face scan)
* Placement of guided orthodontic TADs (Temporary Anchorage Devices)
* Skeletal expansion using CAD/CAM appliance
* Fixed multibracket appliance in the upper and lower jaw
* Intermediate and terminal documents (intraoral scan, CBCT scan, face scan)
Detailed Description:
This clinical trial aims to evaluate the influence of maxillary expansion using a CAD/CAM-manufactured appliance impact on the soft and hard tissues in the midfacial region in adolescent and adult orthodontic patients.
This study aims to evaluate how this treatment changes the bony structures and soft tissues (for example, the nose) in the mid-facial region during the transversal expansion of the maxilla using a CAD/CAM expansion appliance.
The appliance consists of two anchorage elements on the first molars and two TADs. The mini-screws are placed on the palate under local anesthesia with the help of drilling templates.
CAD/CAD milled and 3D printed guides will be used for the placement of the TADs.
The study will be conducted on orthodontic patients between 12 and 26 years who will receive fixed orthodontic braces in the upper and lower jaw and show a width deficit of the upper jaw.
Intraoral, face, and computed tomography (CT) scans will be used for the investigation. An intraoral and face scanner enables a high-resolution 3D image of the teeth and face. A CBCT Scan is a three-dimensional X-ray image.
These examinations do not involve pain and are performed during regular follow-up appointments.
This study aims to evaluate how this treatment changes the bony structures and soft tissues (for example, the nose) in the mid-facial region during the transversal expansion of the maxilla using a CAD/CAM expansion appliance.
The appliance consists of two anchorage elements on the first molars and two TADs. The mini-screws are placed on the palate under local anesthesia with the help of drilling templates.
CAD/CAD milled and 3D printed guides will be used for the placement of the TADs.
The study will be conducted on orthodontic patients between 12 and 26 years who will receive fixed orthodontic braces in the upper and lower jaw and show a width deficit of the upper jaw.
Intraoral, face, and computed tomography (CT) scans will be used for the investigation. An intraoral and face scanner enables a high-resolution 3D image of the teeth and face. A CBCT Scan is a three-dimensional X-ray image.
These examinations do not involve pain and are performed during regular follow-up appointments.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: