Efficacy of Mini-implant Assisted Maxillary Expansion in Adolescents and Adults
- Conditions
- Narrow Maxilla
- Interventions
- Device: Mini-implants assisted maxillary expansion
- Registration Number
- NCT06449014
- Lead Sponsor
- Erasme University Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- from the age of 16 onwards
- who presented with transverse maxillary discrepancy (unilateral, bilateral, anticipated, or constriction without crossbite).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CRAP Mini-implants assisted maxillary expansion 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 SCAP Mini-implants assisted maxillary expansion 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). FCPC Mini-implants assisted maxillary expansion 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)
- Primary Outcome Measures
Name Time Method LID: 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
MPSM: mid-palatal suture middle molars up to 6 months the width of the mid-palatal suture measure in millimeters at the level of the first molars
UID 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.
IMW: intermolar width up to 6 months Transverse distance in millimeters between the left and right maxillary M1 mesiocentral fossae
PAW: palatal alveolar width up to 6 months Transverse distance between in millimeters the left and right most cervical medial limits of the palatal alveolar process
TI : tooth inclination 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
PNS-PNS up to 6 months distance in millimeters between the right posterior nasal spine and the left posterior nasal spine after the maxillary expansion
IPW: interpremolar width up to 6 months Transverse distance in millimeters between the left and right maxillary P1 mesial fossae
MSW: midpalatal suture width up to 6 months Transverse distance in millimeters between the medial limits of the left and right palatal process at the palatal floor
ICW: intercanine width up to 6 months Transverse distance in millimeters between the left and right maxillary canine buccal cusp tips
ANS-ANS up to 6 months the distance in millimeters between the right anterior nasal spine and the left anterior nasal spine after the maxillary expansion
ZMA 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.
NCW: nasal cavity width up to 6 months Transverse distance in millimeters between the left and right most lateral point of the nasal cavity
- Secondary Outcome Measures
Name Time Method NCV: nasal cavity volume up to 6 months nasal cavity volume in mm3
RT resistance total up to 6 months Total bilateral nasal resistance in Pa.s.cm³
OMCSA: oropharynx minimum cross-sectional area up to 6 months oropharynx minimum cross-sectional area in mm2
RMSV : right maxillary sinus volume up to 6 months Right maxillary sinus volume in mm3
NPV nasopharynx volume up to 6 months nasopharynx volume in mm3
OPV oropharynx volume up to 6 months OPV oropharynx volume in mm3
AV: Accumulated volume up to 6 months which represents the total volume in mm3, is calculated using the sum of the NCV, RMSV, LMSV, NPV, and OPV
LMSV : left maxillary sinus volume up to 6 months left maxillary sinus volume in mm3
Trial Locations
- Locations (1)
Route de Lennik 900
🇧🇪Anderlecht, Bruxelles, Belgium