Direct vs Digitally Guided Miniscrew Placement for MARPE

NCT07707596 | Completed

• 1 other identifier: UIC-MARPE-2026-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Maxillary Transverse Deficiency

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Number of miniscrew failures before expansion activation

  At 8 weeks after miniscrew placement

• Number of miniscrews with nasal cavity or maxillary sinus invasion assessed by postoperative CBCT

  Immediately after miniscrew placement

Study Arms (2)

Direct appliance-guided miniscrew placement

EXPERIMENTAL

Participants received MARPE treatment with palatal miniscrews inserted directly using the expansion appliance as the positioning guide.

Procedure: Direct appliance-guided miniscrew placement

Digitally guided CAD/CAM miniscrew placement

EXPERIMENTAL

Participants received MARPE treatment with palatal miniscrews inserted using a digitally planned CAD/CAM surgical guide.

Procedure: Digitally guided CAD/CAM miniscrew placement

Interventions

Direct appliance-guided miniscrew placement PROCEDURE

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

Direct appliance-guided miniscrew placement

Digitally guided CAD/CAM miniscrew placement PROCEDURE

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

Digitally guided CAD/CAM miniscrew placement

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Age \>18 years
• Palatal bone height \<6 mm
• Systemic disease affecting bone metabolism
• Medication affecting bone turnover
• Craniofacial syndromes or cleft conditions

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08017, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd ij Medicien, Doctor Dental Surgery, MSc in orthodontics

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: July 16, 2026
• Study Start: May 1, 2025
• Primary Completion: February 20, 2026
• Study Completion: February 20, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)