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Direct vs Digitally Guided Miniscrew Placement for MARPE

NCT07707596 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-16

No results posted yet for this study

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.

Conditions

  • Maxillary Transverse Deficiency

Interventions

PROCEDURE

Direct appliance-guided miniscrew placement

Palatal miniscrews were inserted manually using the MARPE appliance as the insertion guide according to the planned position.

PROCEDURE

Digitally guided CAD/CAM miniscrew placement

Palatal miniscrews were inserted using a tooth-supported CAD/CAM surgical guide based on digital planning.

Sponsors & Collaborators

  • Universitat Internacional de Catalunya

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-02-20
Completion
2026-02-20

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07707596 on ClinicalTrials.gov