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This randomized clinical trial compared the accuracy, primary stability, and anatomical safety of two protocols for palatal miniscrew placement in adolescents requiring maxillary skeletal expansion. Participants were randomly assigned to either direct appliance-guided miniscrew placement for MARPE or digitally guided CAD/CAM-assisted miniscrew placement. Postoperative CBCT imaging was used to assess placement accuracy and anatomical safety, while clinical evaluation was used to assess primary stability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct appliance-guided miniscrew placement | Experimental | Participants received MARPE treatment with palatal miniscrews inserted directly using the expansion appliance as the positioning guide. |
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| Digitally guided CAD/CAM miniscrew placement | Experimental | Participants received MARPE treatment with palatal miniscrews inserted using a digitally planned CAD/CAM surgical guide. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct appliance-guided miniscrew placement | Procedure | Palatal miniscrews were inserted manually using the MARPE appliance as the insertion guide according to the planned position. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean coronal deviation between planned and achieved miniscrew position | Coronal deviation (mm) measured on postoperative CBCT by comparing the planned and achieved miniscrew positions. | Immediately after miniscrew placement |
| Mean apical deviation between planned and achieved miniscrew position | Apical deviation (mm) measured on postoperative CBCT by comparing the planned and achieved miniscrew positions. | Immediately after miniscrew placement |
| Mean angular deviation between planned and achieved miniscrew position | Angular deviation (degrees) measured on postoperative CBCT by comparing the planned and achieved miniscrew positions. | Immediately after miniscrew placement |
| Measure | Description | Time Frame |
|---|---|---|
| Number of miniscrew failures before expansion activation | Failure is defined as clinical mobility, loss of primary stability, or miniscrew loss before expansion activation. The number of failed miniscrews will be recorded in each study group. | At 8 weeks after miniscrew placement |
| Number of miniscrews with nasal cavity or maxillary sinus invasion assessed by postoperative CBCT |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat Internacional de Catalunya | Sant Cugat del Vallès | Barcelona | 08017 | Spain |
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Participants were randomized in a 1:1 ratio to either direct appliance-guided miniscrew placement for MARPE or digitally guided CAD/CAM-assisted miniscrew placement. Outcomes included placement accuracy, primary stability, and anatomical safety.
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Due to the nature of the interventions, blinding of participants, care providers, investigators, and outcome assessors was not feasible. The study was conducted as an open-label randomized clinical trial.
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| Digitally guided CAD/CAM miniscrew placement | Procedure | Palatal miniscrews were inserted using a tooth-supported CAD/CAM surgical guide based on digital planning. |
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Postoperative CBCT images will be used to evaluate whether miniscrew placement resulted in invasion of adjacent anatomical structures, including the nasal cavity or maxillary sinus. The total number of miniscrews exhibiting anatomical invasion will be recorded. |
| Immediately after miniscrew placement |