Comprehensive Outcomes of Palatal TSADs Treatment

Hospital of the Ministry of Interior, Kielce, Poland

Status

Completed

Conditions

Malocclusions

Treatments

Device: Palatal temporary skeletal anchorage devices

Study type

Interventional

Funder types

Other

Identifiers

NCT07311473

CT/2025/2

Details and patient eligibility

About

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

Enrollment

150 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Presence of a malocclusion requiring palatal temporary skeletal anchorage devices (TSADs)
No previous treatment involving TSADs
Lack of systemic comorbidities
Signed informed consent (and parental consent for minors)

Exclusion criteria

Presence of uncontrolled systemic diseases or conditions that contraindicate orthodontic treatment or the placement of mini-screws
Poor oral hygiene
Allergies to materials used in mini-screws or associated orthodontic appliances
Lack of patient consent for study participation