Maxillary Transverse Deficiency
Conditions
Brief summary
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.
Interventions
PROCEDUREDirect appliance-guided miniscrew placement
Palatal miniscrews were inserted manually using the MARPE appliance as the insertion guide according to the planned position.
PROCEDUREDigitally guided CAD/CAM miniscrew placement
Palatal miniscrews were inserted using a tooth-supported CAD/CAM surgical guide based on digital planning.
Sponsors
Universitat Internacional de Catalunya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age between 12 and 18 years * Transverse maxillary deficiency requiring skeletal expansion * Midpalatal suture maturation stage B or C * Adequate palatal bone height for miniscrew insertion (≥9 mm) * No previous maxillary expansion treatment
Exclusion criteria
* Age \>18 years * Palatal bone height \<6 mm * Systemic disease affecting bone metabolism * Medication affecting bone turnover * Craniofacial syndromes or cleft conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean coronal deviation between planned and achieved miniscrew position | Immediately after miniscrew placement | Coronal deviation (mm) measured on postoperative CBCT by comparing the planned and achieved miniscrew positions. |
| Mean apical deviation between planned and achieved miniscrew position | Immediately after miniscrew placement | Apical deviation (mm) measured on postoperative CBCT by comparing the planned and achieved miniscrew positions. |
| Mean angular deviation between planned and achieved miniscrew position | Immediately after miniscrew placement | Angular deviation (degrees) measured on postoperative CBCT by comparing the planned and achieved miniscrew positions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of miniscrew failures before expansion activation | At 8 weeks after miniscrew placement | 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. |
| Number of miniscrews with nasal cavity or maxillary sinus invasion assessed by postoperative CBCT | Immediately after miniscrew placement | 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. |
Countries
Spain
Outcome results
None listed