Mini-implant assisted maxillary expansion for late 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)
NA · Erasme University Hospital · NCT06449014
This trial tests whether MARPE (mini-implant assisted rapid palatal expansion) using different activation schedules can widen the upper jaw and improve nasal airflow in people aged 16 and older with a narrow maxilla.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Erasme University Hospital (other) |
| Locations | 2 sites (Anderlecht, Brussels Capital and 1 other locations) |
| Trial ID | NCT06449014 on ClinicalTrials.gov |
What this trial studies
This is a three-arm, parallel-group randomized controlled trial conducted at the Orthodontics clinic of Erasme University Hospital in Brussels. All participants receive MARPE with four mini-screws and are randomized to one of three activation protocols (continuous rapid, continuous slow, or a force-controlled polycyclic protocol). The appliance is left in place for 12 months to allow bone remodeling, with fixed orthodontic treatment beginning about two months after expansion ends and retention checks at 6 and 12 months. Primary outcomes include success rate of nonsurgical maxillary expansion and secondary outcomes measure nasal permeability and airway volume using rhinomanometry and imaging.
Who should consider this trial
Good fit: People aged 16 years and older with transverse maxillary discrepancy who have not undergone prior palatal expansion and who do not have excluded craniofacial conditions are ideal candidates.
Not a fit: Patients with prior maxillofacial surgery, cleft lip or palate, craniofacial syndromes, periodontal disease, anatomical obstacles to mini-screw insertion, or prior palatal expansion are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could offer a reliable non-surgical option to widen the upper jaw in older teens and adults and potentially improve nasal breathing.
How similar studies have performed: Previous clinical reports and trials indicate MARPE can open the midpalatal suture in many late adolescents and adults, but outcomes vary and optimal activation protocols and airway effects are not consistently established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Anderlecht, Brussels Capital and 1 other locations
- Route de Lennik 900 — Anderlecht, Brussels Capital, Belgium (NOT_YET_RECRUITING)
- service dentaire et d'orthodontie de l'hopital université de bruxelles (HUB) — Anderlecht, Brussels Capital, Belgium (RECRUITING)
Study contacts
- Study coordinator: arnel NANA, Dr
- Email: narnelredon@gmail.com
- Phone: +32460952160
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Narrow Maxilla, MARPE, Endognathia, rhinomanometry