Actively Recruiting
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
Led by Erasme University Hospital · Updated on 2025-08-11
60
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Transverse maxillary deficiency affects about 10% of adults and often requires strong forces to expand the midpalatal suture in late adolescents and adults. Researchers are evaluating the use of mini-implant assisted rapid palatal expansion (MARPE) to treat this condition. The study aims to compare three different activation protocols for non-surgical maxillary expansion and assess their effects on nasal airflow and airway volume. The trial is a randomized controlled study with three groups. Each group receives MARPE treatment with different activation schedules: a continuous rapid protocol with daily small expansions, a continuous slow protocol with higher initial expansions followed by less frequent adjustments, and a force-controlled polycyclic protocol involving back and forth screw turns plus regular activations. Four mini-screws are inserted under local anesthesia without surgery, and the device stays in place for 12 months to allow bone remodeling before removal. Fixed orthodontic treatment begins two months after expansion ends. Participants will have follow-up visits at 6 and 12 months to check retention and device status. Researchers will measure changes in midpalatal suture width, dental arch widths, nasal cavity dimensions, and airway volumes up to six months after expansion. The study also looks at success rates, complications, and how factors like age, sex, and suture maturation affect outcomes. Total participation lasts about a year including expansion and monitoring.
CONDITIONS
Brief Title
Efficacy of Mini-implant Assisted Maxillary Expansion in Adolescents and Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 16 years of age or older
- Presence of transverse maxillary discrepancy (unilateral, bilateral, anticipated, or constriction without crossbite)
You will not qualify if you...
- History or presence of maxillofacial surgery, cleft lip and palate, craniofacial anomalies or syndromes, congenital tooth anomalies, or periodontal disease
- Previous palatal expansion treatment
- Anatomic or pathological obstacles to palatal mini-screw insertion (such as impacted tooth or tumor)
- Refusal to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 weeks until expander placement
Participants undergo placement of orthodontic mini-screws in the palate under local anesthesia without surgical incision, followed by intraoral scanning for appliance fabrication. Approximately three weeks later, the expander is placed in the palate and maxillary expansion is initiated immediately according to the assigned activation protocol.
2 visits (mini-screw insertion and expander placement)
Duration - Up to 12 months
Participants undergo maxillary expansion using one of three activation protocols involving daily or periodic activation of the expansion screw until reaching the clinical goal. The appliance remains in place for 12 months after expansion to allow bone remodeling.
Daily or periodic activations as per protocol; visits for monitoring as scheduled
Duration - Up to 12 months post-expansion
Participants receive retention check-ups at 6 and 12 months post-expansion. Expansion screws and mini-screws are removed after 12 months or before orthognathic surgery if applicable. Fixed straight-wire orthodontic treatment commences 2 months after expansion ends.
Approximately 2 visits at 6 and 12 months post-expansion plus screw removal visit
Trial Site Locations
Total: 2 locations
1
Route de Lennik 900
Anderlecht, Brussels Capital, Belgium, 1070
Not Yet Recruiting
2
service dentaire et d'orthodontie de l'hopital université de bruxelles (HUB)
Anderlecht, Brussels Capital, Belgium, 1070
Actively Recruiting
Research Team
A
arnel NANA, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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