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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Palatal miniscrews were inserted manually using the MARPE appliance as the insertion guide according to the planned position.
Palatal miniscrews were inserted using a tooth-supported CAD/CAM surgical guide based on digital planning.
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, Spain
Mean coronal deviation between planned and achieved miniscrew position
Coronal deviation (mm) measured on postoperative CBCT by comparing the planned and achieved miniscrew positions.
Time frame: 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.
Time frame: 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.
Time frame: Immediately after miniscrew placement
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.
Time frame: At 8 weeks after miniscrew placement
Number of miniscrews with nasal cavity or maxillary sinus invasion assessed by postoperative CBCT
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.
Time frame: Immediately after miniscrew placement
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