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

NCT06449014 | Recruiting

• 1 other identifier: Erasme_MARPE_1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Narrow Maxilla

Keywords

MARPE; Endognathia; rhinomanometry

Outcome Measures

Primary Outcomes (13)

• MPSM: mid-palatal suture middle molars

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

  up to 6 months

• ANS-ANS

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

  up to 6 months

• PNS-PNS

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

  up to 6 months

• UID

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

  up to 6 months

• ZMA

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

  up to 6 months

• LID:

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

  up to 6 months

• NCW: nasal cavity width

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

  up to 6 months

• MSW: midpalatal suture width

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

  up to 6 months

• IMW: intermolar width

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

  up to 6 months

• IPW: interpremolar width

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

  up to 6 months

• ICW: intercanine width

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

  up to 6 months

• PAW: palatal alveolar width

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

  up to 6 months

• TI : tooth inclination

  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

  up to 6 months

Secondary Outcomes (8)

• RT resistance total

  up to 6 months

• NCV: nasal cavity volume

  up to 6 months

• RMSV : right maxillary sinus volume

  up to 6 months

• LMSV : left maxillary sinus volume

  up to 6 months

• NPV nasopharynx volume

  up to 6 months

Study Arms (3)

CRAP

EXPERIMENTAL

Continuous Rapid Activation Protocol: 1 activation of the expansion screw per day which is equal to 0,17 mm expansion of the maxilla per day till reaching the clinical goal

Device: Mini-implants assisted maxillary expansion

SCAP

EXPERIMENTAL

Continuous Slow Activation Protocol: 2 activations of the expansion screw which is equal to 0,33 mm expansion of the maxilla per day during the first 7 days. After that first week, then each third day 1 activation (0,17 mm / 3 days).

Device: Mini-implants assisted maxillary expansion

FCPC

EXPERIMENTAL

force-controlled polycyclic protocol: 2 activations of the expansion screw which is equal to 0,33 mm expansion of the maxilla per day during the first 7 days. Then the expansion screw will be turned 6 sides backward, and after 15 min, the expansion screw will be turned forward 6 sides again. And every third day, the device will be additionally activated by 0.17mm (0,17 mm / 3 days)

Device: Mini-implants assisted maxillary expansion

Interventions

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.

Also known as: Mini-screws assisted maxillary expansion, Mini-implants assisted rapid maxillary expansion

CRAP; FCPC; SCAP

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (2)

Route de Lennik 900

Anderlecht, Brussels Capital, 1070, Belgium

NOT YET RECRUITING

service dentaire et d'orthodontie de l'hopital université de bruxelles (HUB)

Anderlecht, Brussels Capital, 1070, Belgium

RECRUITING

Central Study Contacts

arnel NANA, Dr

CONTACT

+32460952160; narnelredon@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 7, 2024
• Study Start: October 2, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 11, 2025

Record last verified: 2024-12

Locations

BE (2)