Direct vs Digitally Guided Miniscrew Placement for MARPE (MARPE-GUIDE)

Direct vs Digitally Guided Palatal Miniscrew Placement for MARPE: A Randomized Clinical Trial on Accuracy, Stability, and Anatomical Safety

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 Overview

• Status: Completed
• Conditions: Maxillary Transverse Deficiency
• Intervention / Treatment: Procedure: Direct appliance-guided miniscrew placement; Procedure: Digitally guided CAD/CAM miniscrew placement

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sant Cugat del Vallès, Barcelona, Spain, 08017
      • Universitat Internacional de Catalunya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Direct appliance-guided miniscrew placement; Participants received MARPE treatment with palatal miniscrews inserted directly using the expansion appliance as the positioning guide.	Procedure: Direct appliance-guided miniscrew placement; Palatal miniscrews were inserted manually using the MARPE appliance as the insertion guide according to the planned position.
Experimental: Digitally guided CAD/CAM miniscrew placement; Participants received MARPE treatment with palatal miniscrews inserted using a digitally planned CAD/CAM surgical guide.	Procedure: Digitally guided CAD/CAM miniscrew placement; Palatal miniscrews were inserted using a tooth-supported CAD/CAM surgical guide based on digital planning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Actual): February 20, 2026
• Study Completion (Actual): February 20, 2026

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: UIC-MARPE-2026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No