NCT07311473

Comprehensive Outcomes of Palatal TSADs Treatment

Comprehensive Evaluation of Treatment Outcomes in Patients Treated With Palatal Temporary Skeletal Anchorage Devices

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Hospital of the Ministry of Interior, Kielce, Poland · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate clinical outcomes, patient-reported quality of life, the precision of surgical guides used for placing orthodontic mini-screws, and potential complications associated with the use of palatal temporary skeletal anchorage devices (TSADs) in orthodontically treated patients. The main questions it aims to answer are: * What is the clinical effectiveness of palatal TSADs in orthodontic treatment outcomes? * How do palatal TSADs affect the quality of life in orthodontic patients? * How accurately do surgical guides transfer the digitally planned positions of mini-screws to their actual positions? * What are the complications associated with the use of palatal TSADs in orthodontic treatment? Participants will: * Receive orthodontic treatment involving the placement of palatal TSADs * Complete validated, standardized questionnaires assessing quality of life * Be evaluated for skeletal and dental changes and monitored for clinical and technical complications throughout the course of treatment

Conditions

• Malocclusions

Interventions

Type	Name	Description
DEVICE	Palatal temporary skeletal anchorage devices	Participants will receive orthodontic treatment involving the placement of palatal TSADs. Prior to the procedure, a cone-beam computed tomography (CBCT) scan will be obtained. Local anesthesia (0.2-0.5 mL) will be administered, after which two 2-mm diameter mini-implants will be inserted using a patient-specific surgical guide, and a palatal appliance will be positioned.

Timeline

• Start date: 2023-01-03
• Primary completion: 2025-09-10
• Completion: 2025-10-21
• First posted: 2025-12-31
• Last updated: 2025-12-31

Locations

1 site across 1 country: Poland