Viewing Study NCT04863404



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Last Modification Date: 2024-10-26 @ 2:03 PM
Study NCT ID: NCT04863404
Status: UNKNOWN
Last Update Posted: 2021-04-28
First Post: 2021-04-21

Brief Title: Evaluation of the Treatment Effects of Tooth Borne Versus Bone-anchored Protraction Procedures in Class III Patients With Maxillary Deficiency
Sponsor: Izmir Katip Celebi University
Organization: Izmir Katip Celebi University

Study Overview

Official Title: Evaluation of the Treatment Effects of Tooth Borne Versus Bone-anchored Protraction Procedures in Class III Patients With Maxillary Deficiency
Status: UNKNOWN
Status Verified Date: 2021-04
Last Known Status: 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: The aim of this prospective randomized controlled clinical study is to compare the effects of bone-anchored and tooth borne maxillary protraction on dentofacial structures in skeletal Class III patients
Detailed Description: Today the treatment of class III malocclusion is becoming more important due to the increased awareness of people about their appearance and the impact of appearance on the psychosocial state

Various studies have shown that 40 of class III malocclusions are clinically caused by maxillary deficiency 42 by mandibular excess and 18 by a combination of maxillary deficiency and mandibular excess

The face mask is the most effective treatment modality for class III malocclusions caused by a maxillary deficiency The rationale for using a face mask is to apply heavy forces to the midface to advance the maxilla forward These forces cause disarticulation by initiating resorption and apposition in the sutural articulations However undesirable dental effects arise from the use of tooth-borne rapid maxillary expansion RME during these treatments These include loss of anchorage and incisor proclination during the mesialization of the maxillary dentition extrusion of the upper molars and posterior mandibular rotation and insufficient anterior displacement of the maxilla 1-3 mm

Studies have shown that increasing the skeletal effects can reduce post-treatment relapse one of the most important problems in orthodontics

To increase the amount of maxillary skeletal advancement and to minimize the side effects of tooth-borne maxillary expansion and protraction a new bone-anchored hybrid hyrax appliance has been proposed Hybrid hyrax treatment has the following advantages over tooth-borne mechanics

Since the force is applied close to the center of resistance of the maxilla counterclockwise rotation of the maxilla and related posterior mandibular rotation are not observed
Transversal forces are applied to premolars or deciduous molars and mini implants without the risk of periodontal damage fenestration and dehiscence that may occur with tooth-borne appliances are avoided
Mesial migration of the dentition proclination of the upper incisors and occupation of the necessary place for the canines to erupt are avoided
Treatment is minimally invasive
Upper and lower arches remain completely accessible for orthodontic interventions
Only skeletal maxillary advancement is achieved In our study additionally the Alternate Rapid Maxillary Expansion and Constriction AltRamec protocol which increases the skeletal effects during maxillary protraction by providing more effective disarticulation of circummaxillary sutures than conventional rapid maxillary expansion was used

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