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NCT Number: NCT06449014

Efficacy of Mini-implant Assisted Maxillary Expansion in Adolescents and Adults

Transverse maxillary deficiency is a common orthodontic issue, affecting around 10% of adults. Late adolescents and adults often require more force to expand the midpalatal suture due to its increased interdigitation. This study aims to assess the effectiveness of MARPE in this demographic and determine the best activation protocol for non-surgical maxillary expansion using mini-screw-supported appliances. Additionally, the study will evaluate the effectiveness of MARPE on nasal permeability and airway volume.

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Key information

Conditions

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Route de Lennik 900, Anderlecht, Brussels Capital, Belgium

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About this study

The study design comprised a three-arm, parallel-group randomized controlled trial (RCT) conducted at the Orthodontics clinic of Brussels University Hospital. Patients were randomly allocated into one of three groups:

  • Continuous rapid activation protocol: Patients received one activation of 0.17 mm per day until reaching the clinical goal.
  • Continuous slow activation protocol: Patients underwent two activations (0.33 mm) per day for the first 7 days, followed by one turn forward every third day (0.17 mm / 3 days).
  • Force-controlled polycyclic protocol: Patients underwent two activations (0.33 mm) per day for the first 7 days. Then, the hex nut was turned 6 sides backward, followed by 6 sides forward after 15 minutes. Additionally, the device was activated by 0.17 mm every third day.

Intervention:

All patients underwent maxillary expansion with MARPE. Four orthodontic mini-screws were inserted under local anesthesia using a surgical guide and motor. Surgical incision was not required, and predrilling was performed if necessary. The MARPE remained in place for 12 months after expansion to allow bone remodeling in the midpalatal suture. Fixed straight-wire treatment commenced 2 months after expansion termination. Patients underwent retention check-ups at 6 and 12 months post-expansion, and expansion screws and mini-screws were removed after 12 months or before orthognathic surgery, if applicable.

The specific aims of the study were to evaluate the success rate of nonsurgical maxillary expansion, compare the efficacy of the three activation protocols, assess and compare complications, analyze the correlation between success rate and Midpalatal Suture Maturation Stage (MPS), age, and sex, and measure nasal permeability variation using anterior rhinomanometry.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • from the age of 16 onwards
  • who presented with transverse maxillary discrepancy (unilateral, bilateral, anticipated, or constriction without crossbite).

Exclusion criteria

  • history or presence of maxillofacial surgery, cleft lip and palate, craniofacial anomalies or syndromes, congenital tooth anomalies, and periodontal disease.
  • Patients who had previously palatal expansion were excluded also.
  • Presence of anatomic or pathological obstacle of the palatal mini-screw insertion (impacted tooth, tumor.)
  • refusal of study participation

Treatment and study plan

Mini-implants assisted maxillary expansion

Device

The intervention involved the placement of orthodontic mini-screws in the patient's palate, varying in diameter from 2 to 2.3 mm and in length from 11 to 15 mm. After mini-screw insertion, another intraoral scan was taken for the fabrication of the appliance. Approximately three weeks later, the expander was placed in the patient's palate, and maxillary expansion was initiated immediately afterward according to the chosen protocol.

Other names: Mini-screws assisted maxillary expansion, Mini-implants assisted rapid maxillary expansion

Primary outcomes

  1. MPSM: mid-palatal suture middle molars

    Time frame: up to 6 months

    the width of the mid-palatal suture measure in millimeters at the level of the first molars

  2. ANS-ANS

    Time frame: up to 6 months

    the distance in millimeters between the right anterior nasal spine and the left anterior nasal spine after the maxillary expansion

  3. PNS-PNS

    Time frame: up to 6 months

    distance in millimeters between the right posterior nasal spine and the left posterior nasal spine after the maxillary expansion

  4. UID

    Time frame: up to 6 months

    distance in millimeters from the most external point of the right frontozygomatic suture to the most external point of the left frontozygomatic suture.

  5. ZMA

    Time frame: up to 6 months

    width in millimeters between the right and left zygomatic arches at its widest point at the most inferior level of the orbits.

  6. LID:

    Time frame: up to 6 months

    distance in millimeters from the most external point of the right zygomaticomaxillary suture to the most external point of the left zygomaticomaxillary suture

  7. NCW: nasal cavity width

    Time frame: up to 6 months

    Transverse distance in millimeters between the left and right most lateral point of the nasal cavity

  8. MSW: midpalatal suture width

    Time frame: up to 6 months

    Transverse distance in millimeters between the medial limits of the left and right palatal process at the palatal floor

  9. IMW: intermolar width

    Time frame: up to 6 months

    Transverse distance in millimeters between the left and right maxillary M1 mesiocentral fossae

  10. IPW: interpremolar width

    Time frame: up to 6 months

    Transverse distance in millimeters between the left and right maxillary P1 mesial fossae

  11. ICW: intercanine width

    Time frame: up to 6 months

    Transverse distance in millimeters between the left and right maxillary canine buccal cusp tips

  12. PAW: palatal alveolar width

    Time frame: up to 6 months

    Transverse distance between in millimeters the left and right most cervical medial limits of the palatal alveolar process

  13. TI : tooth inclination

    Time frame: up to 6 months

    2D inner angle (in degrees) between the palatal plane and the left and right line running through the palatal apex and the mesiobuccal fossa or the mesial fossa

Secondary outcomes

  1. RT resistance total

    Time frame: up to 6 months

    Total bilateral nasal resistance in Pa.s.cm³

  2. NCV: nasal cavity volume

    Time frame: up to 6 months

    nasal cavity volume in mm3

  3. RMSV : right maxillary sinus volume

    Time frame: up to 6 months

    Right maxillary sinus volume in mm3

  4. LMSV : left maxillary sinus volume

    Time frame: up to 6 months

    left maxillary sinus volume in mm3

  5. NPV nasopharynx volume

    Time frame: up to 6 months

    nasopharynx volume in mm3

  6. OPV oropharynx volume

    Time frame: up to 6 months

    OPV oropharynx volume in mm3

  7. OMCSA: oropharynx minimum cross-sectional area

    Time frame: up to 6 months

    oropharynx minimum cross-sectional area in mm2

  8. AV: Accumulated volume

    Time frame: up to 6 months

    which represents the total volume in mm3, is calculated using the sum of the NCV, RMSV, LMSV, NPV, and OPV

Study contacts

Contact information is provided by the study sponsor or research team.

arnel NANA, Dr

CONTACT

[email protected]

+32460952160

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

Efficacy of Mini-Implant-Assisted Maxillary Expansion on Late Adolescents and Adults and Its Effects on Nasal Permeability and Airway Volume Using Three Different Activation Protocols: A Randomized Controlled Trial (MARPE_1)

Acronym: MARPE_1

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 7, 2024
Registry last updated
Aug 11, 2025

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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