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OpenTrials
Completed

NCT Number: NCT07707596

Direct vs Digitally Guided Miniscrew Placement for MARPE

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.

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Key information

Conditions

Maxillary Transverse Deficiency

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08017, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Direct appliance-guided miniscrew placement

Procedure

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

Digitally guided CAD/CAM miniscrew placement

Procedure

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

Primary outcomes

  1. Mean coronal deviation between planned and achieved miniscrew position

    Time frame: Immediately after miniscrew placement

    Coronal deviation (mm) measured on postoperative CBCT by comparing the planned and achieved miniscrew positions.

  2. Mean apical deviation between planned and achieved miniscrew position

    Time frame: Immediately after miniscrew placement

    Apical deviation (mm) measured on postoperative CBCT by comparing the planned and achieved miniscrew positions.

  3. Mean angular deviation between planned and achieved miniscrew position

    Time frame: Immediately after miniscrew placement

    Angular deviation (degrees) measured on postoperative CBCT by comparing the planned and achieved miniscrew positions.

Secondary outcomes

  1. Number of miniscrew failures before expansion activation

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Registry information

Official study title

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

Acronym: MARPE-GUIDE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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