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

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)

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06449014
Acronym
MARPE_1
Enrollment
60
Registered
2024-06-07
Start date
2024-10-02
Completion date
2027-09-30
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Narrow Maxilla

Keywords

MARPE, Endognathia, rhinomanometry

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.

Detailed description

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: 1. Continuous rapid activation protocol: Patients received one activation of 0.17 mm per day until reaching the clinical goal. 2. 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). 3. 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.

Interventions

DEVICEMini-implants assisted maxillary expansion

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.

Sponsors

Erasme University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
TI : tooth inclinationup to 6 months2D 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
ZMAup to 6 monthswidth in millimeters between the right and left zygomatic arches at its widest point at the most inferior level of the orbits.
LID:up to 6 monthsdistance in millimeters from the most external point of the right zygomaticomaxillary suture to the most external point of the left zygomaticomaxillary suture
NCW: nasal cavity widthup to 6 monthsTransverse distance in millimeters between the left and right most lateral point of the nasal cavity
MSW: midpalatal suture widthup to 6 monthsTransverse distance in millimeters between the medial limits of the left and right palatal process at the palatal floor
IMW: intermolar widthup to 6 monthsTransverse distance in millimeters between the left and right maxillary M1 mesiocentral fossae
IPW: interpremolar widthup to 6 monthsTransverse distance in millimeters between the left and right maxillary P1 mesial fossae
ICW: intercanine widthup to 6 monthsTransverse distance in millimeters between the left and right maxillary canine buccal cusp tips
PAW: palatal alveolar widthup to 6 monthsTransverse distance between in millimeters the left and right most cervical medial limits of the palatal alveolar process
MPSM: mid-palatal suture middle molarsup to 6 monthsthe width of the mid-palatal suture measure in millimeters at the level of the first molars
ANS-ANSup to 6 monthsthe distance in millimeters between the right anterior nasal spine and the left anterior nasal spine after the maxillary expansion
PNS-PNSup to 6 monthsdistance in millimeters between the right posterior nasal spine and the left posterior nasal spine after the maxillary expansion
UIDup to 6 monthsdistance in millimeters from the most external point of the right frontozygomatic suture to the most external point of the left frontozygomatic suture.

Secondary

MeasureTime frameDescription
OMCSA: oropharynx minimum cross-sectional areaup to 6 monthsoropharynx minimum cross-sectional area in mm2
AV: Accumulated volumeup to 6 monthswhich represents the total volume in mm3, is calculated using the sum of the NCV, RMSV, LMSV, NPV, and OPV
RT resistance totalup to 6 monthsTotal bilateral nasal resistance in Pa.s.cm³
NCV: nasal cavity volumeup to 6 monthsnasal cavity volume in mm3
RMSV : right maxillary sinus volumeup to 6 monthsRight maxillary sinus volume in mm3
LMSV : left maxillary sinus volumeup to 6 monthsleft maxillary sinus volume in mm3
NPV nasopharynx volumeup to 6 monthsnasopharynx volume in mm3
OPV oropharynx volumeup to 6 monthsOPV oropharynx volume in mm3

Countries

Belgium

Contacts

Primary Contactarnel NANA, Dr
narnelredon@gmail.com+32460952160

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026