Efficacy of Mini-implant Assisted Maxillary Expansion in Adolescents and Adults
ConditionNarrow Maxilla
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorErasme University Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
from the age of 16 onwards
who presented with transverse maxillary discrepancy (unilateral, bilateral, anticipated, or constriction without crossbite).
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Mini-implants assisted maxillary expansion
DeviceThe 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: CRAPExperimental treatment 1 intervention
Group B: SCAPExperimental treatment 1 intervention
Group C: FCPCExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
MPSM: mid-palatal suture middle molars
the width of the mid-palatal suture measure in millimeters at the level of the first molars
Time frame
up to 6 months2
ANS-ANS
the distance in millimeters between the right anterior nasal spine and the left anterior nasal spine after the maxillary expansion
Time frame
up to 6 months3
PNS-PNS
distance in millimeters between the right posterior nasal spine and the left posterior nasal spine after the maxillary expansion
Time frame
up to 6 months4
UID
distance in millimeters from the most external point of the right frontozygomatic suture to the most external point of the left frontozygomatic suture.
Time frame
up to 6 monthsSecondary outcomes
1
RT resistance total
Total bilateral nasal resistance in Pa.s.cm³
Time frame
up to 6 months2
NCV: nasal cavity volume
nasal cavity volume in mm3
Time frame
up to 6 months3
RMSV : right maxillary sinus volume
Right maxillary sinus volume in mm3
Time frame
up to 6 months4
LMSV : left maxillary sinus volume
left maxillary sinus volume in mm3
Time frame
up to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov