Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449014
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-23
Brief Title:
Efficacy of Mini-implant Assisted Maxillary Expansion in Adolescents and Adults
Sponsor:
Erasme University Hospital
Organization:
Erasme University Hospital
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MARPE_1
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 017 mm per day until reaching the clinical goal
2 Continuous slow activation protocol Patients underwent two activations 033 mm per day for the first 7 days followed by one turn forward every third day 017 mm 3 days
3 Force-controlled polycyclic protocol Patients underwent two activations 033 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 017 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
1 Continuous rapid activation protocol Patients received one activation of 017 mm per day until reaching the clinical goal
2 Continuous slow activation protocol Patients underwent two activations 033 mm per day for the first 7 days followed by one turn forward every third day 017 mm 3 days
3 Force-controlled polycyclic protocol Patients underwent two activations 033 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 017 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None