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Comprehensive Outcomes of Palatal TSADs Treatment

NCT07311473 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-12-31

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hospital of the Ministry of Interior, Kielce, Poland

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-03
Primary Completion
2025-09-10
Completion
2025-10-21

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07311473 on ClinicalTrials.gov