Clinical trial NCT06449014: Efficacy of Mini-implant Assisted Maxillary Expansion in Adolescents and Adults
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Narrow Maxilla
Keywords: MARPE
Endognathia
rhinomanometry
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: MPSM: mid-palatal suture middle molars
timeFrame: up to 6 months
measure: ANS-ANS
timeFrame: up to 6 months
measure: PNS-PNS
timeFrame: up to 6 months
measure: UID
timeFrame: up to 6 months
measure: ZMA
timeFrame: up to 6 months
measure: LID:
timeFrame: up to 6 months
measure: NCW: nasal cavity width
timeFrame: up to 6 months
measure: MSW: midpalatal suture width
timeFrame: up to 6 months
measure: IMW: intermolar width
timeFrame: up to 6 months
measure: IPW: interpremolar width
timeFrame: up to 6 months
measure: ICW: intercanine width
timeFrame: up to 6 months
measure: PAW: palatal alveolar width
timeFrame: up to 6 months
measure: TI : tooth inclination
timeFrame: up to 6 months
Secondary outcomes:
measure: RT resistance total
timeFrame: up to 6 months
measure: NCV: nasal cavity volume
timeFrame: up to 6 months
measure: RMSV : right maxillary sinus volume
timeFrame: up to 6 months
measure: LMSV : left maxillary sinus volume
timeFrame: up to 6 months
measure: NPV nasopharynx volume
timeFrame: up to 6 months
measure: OPV oropharynx volume
timeFrame: up to 6 months
measure: OMCSA: oropharynx minimum cross-sectional area
timeFrame: up to 6 months
measure: AV: Accumulated volume
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Anderlecht
country: Belgium
facility: Route de Lennik 900
state: Bruxelles
Study officials:
References: