Malocclusions
Conditions
Brief 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
Interventions
DEVICEPalatal 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
Hospital of the Ministry of Interior, Kielce, Poland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in maxillary width before and after TSAD-supported orthodontic treatment | Baseline (pre-treatment) and through completion of orthodontic treatment (up to 24 months). | This primary outcome measure assesses changes in palatal width (in millimeters) among patients undergoing orthodontic treatment with temporary skeletal anchorage devices (TSADs). Measurements of palatal width will be conducted at two distinct time points: at baseline (prior to initiation of orthodontic treatment) and upon completion of the treatment. Measurements will be conducted using imaging techniques. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Types of Complications Associated with Orthodontic Treatment Using Palatal TSADs | Periprocedural period and up to 8 weeks post TSAD insertion. | This secondary outcome measure is designed to evaluate the number, frequency, and types of complications specifically associated with TSADs and the palatal appliance during the periprocedural period and up to 8 weeks following TSAD insertion. The analysis will consider both the quantitative occurrence and qualitative characteristics of these early complications, providing insight into the short-term safety and clinical tolerability of TSAD-supported orthodontic therapy. |
| Patient-Reported Quality of Life During TSAD-Supported Use of the Palatal Appliance | Baseline (Day 0, day of appliance placement) through 8 weeks post-insertion. | This secondary outcome measure evaluates patient-reported quality of life during the adaptation period to the palatal appliance supported by TSADs. On the day of appliance placement, patients will receive a self-administered questionnaire designed to assess subjective experiences related to wearing the appliance. The questionnaire includes, among others, items addressing discomfort or pain, difficulties during the initial adaptation phase, speech disturbances, or eating challenges. Completed questionnaires will be collected by the investigator at the subsequent orthodontic follow-up visit. The analysis will provide insight into the overall impact of the TSAD-supported palatal appliance on daily functioning. |
| Accuracy of Patient-Specific Surgical Guides for Palatal Mini-Screw Placement | Periprocedural (Day 0, immediately after placement of mini-screws using the surgical guide). | This secondary outcome measure evaluates the precision of surgical guides used for the placement of palatal mini-screws during orthodontic treatment. Accuracy will be assessed by comparing the digitally planned positions of the mini-screws with their actual positions. |
Countries
Poland
Outcome results
None listed