Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04884022
Status:
UNKNOWN
Last Update Posted:
2022-07-27
First Post:
2021-04-24
Brief Title:
Effectiveness of Two Skeletally Anchored Force Mechanics for Skeletal Class II Correction in Growing Patients
Sponsor:
Alexandria University
Organization:
Alexandria University
Study Overview
Official Title:
Effectiveness of Two Skeletally Anchored Force Mechanics for Correction of Skeletal Class II Malocclusion in Growing Patients A Randomized Controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
Patients with skeletal Class II malocclusion due to mandibular retrognathism will be recruited and randomly allocated to three equal groups first group will be treated by pushing orthopedic force mechanics second group will be treated by pulling orthopedic force mechanics and third group will be observed for 9 months to detect the natural growth changes Skeletal changes will be evaluated and the treatment changes will be compared with the natural growth changes The study hypothesis is that use of direct bimaxillary miniplate anchorage in conjunction with fixed functional appliance pushing orthopedic force or closed coil spring pulling orthopedic force will induce statistically significant skeletal mandibular growth in comparison to natural mandibular growth changes
Detailed Description:
A randomized controlled clinical trial will be conducted to address the aim of the study Thirty-nine growing patients with skeletal Class II malocclusion due to mandibular retrognathism will be recruited The sample will be randomly allocated to three equal groups each including thirteen subjects Group A will be treated by pushing orthopedic force mechanics using fixed functional appliance Sabbagh Advanced Repositioning Appliance anchored to four miniplates two miniplates inserted in the mandibular symphysis and two infrazygomatic miniplates and Group B will be treated by pulling orthopedic force mechanics using Class II springs CS Class II correction device anchored to four miniplates two inserted in the mandibular posterior buccal segment and two inserted in the maxillary anterior segment In both groups the appliances will be removed after reaching an edge-to-edge incisor relationship or after 9 months whichever happens first A similar third group Group C will be observed for 9 months to detect the natural growth changes Skeletal changes will be evaluated using pretreatment and posttreatment cone beam computed tomography scans CBCT The treatment changes will be compared with the natural growth changes observed in group C Other variables will be also examined including the dentoalveolar effects the soft tissue profile and the patients acceptance to this treatment modality
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