Efficacy of Mini-implant Assisted Maxillary Expansion in Adolescents and Adults (MARPE_1)

Free University of Brussels (ULB)

Status: Enrolling

Conditions: Narrow Maxilla

Treatments: Device: Mini-implants assisted maxillary expansion

Study type: Interventional

Funder types: Other

Identifiers

NCT06449014

Erasme_MARPE_1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

CRAP

Experimental group

Description:

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

Treatment:

Device: Mini-implants assisted maxillary expansion

SCAP

Experimental group

Description:

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).

Treatment:

Device: Mini-implants assisted maxillary expansion

FCPC

Experimental group

Description:

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)

Treatment:

Device: Mini-implants assisted maxillary expansion