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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palatal Temporary Skeletal Anchorage Devices | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palatal temporary skeletal anchorage devices | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in maxillary width before and after TSAD-supported orthodontic treatment | 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. | Baseline (pre-treatment) and through completion of orthodontic treatment (up to 24 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Types of Complications Associated with Orthodontic Treatment Using Palatal TSADs | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ortostrefa Orthodontic Clinic | Nowy Sącz | 33-300 | Poland |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Periprocedural period and up to 8 weeks post TSAD insertion. |
| Patient-Reported Quality of Life During TSAD-Supported Use of the Palatal Appliance | 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. | Baseline (Day 0, day of appliance placement) through 8 weeks post-insertion. |
| Accuracy of Patient-Specific Surgical Guides for Palatal Mini-Screw Placement | 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. | Periprocedural (Day 0, immediately after placement of mini-screws using the surgical guide). |