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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04863404
Other study ID # 2021-TDU-DISF-0003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 15, 2020
Est. completion date October 20, 2021

Study information

Verified date April 2021
Source Izmir Katip Celebi University
Contact Burcin AKAN, Phd
Phone +90 5367103040
Email Burcin.yksel@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date October 20, 2021
Est. primary completion date May 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 13 Years
Eligibility Inclusion Criteria: - Late mixed or early permanent dentition - C3 or C4 period according to the cervical vertebral maturation method - Presence of skeletal class III malocclusion (ANB <0 °). - Retrusive nasomaxillary complex (Nperp-A <1 mm). - Presence of dental class III malocclusion - Normal or horizontal growth pattern (SNGoGn <40 °). - Negative overjet (overjet <0) - Good cooperation - Absence of any systemic disease - Periodontal health - No previous orthodontic treatment - No craniofacial deformity - No neuromuscular deformity - The absence of a congenital anomaly Exclusion Criteria: - Poor cooperation - Early mixed dentition - Individuals who have passed the C4 period - Craniofacial deformity - Congenital anomaly - A history of facial trauma Syndromes such as cleft lip and palate

Study Design


Intervention

Other:
Face mask with hybrid-hyrax
Face mask with hybrid-hyrax
Face mask with conventional bonded RME
Face mask with conventional bonded RME

Locations

Country Name City State
Turkey Izmir Katip Celebi University,Faculty of Dentistry, Department of Orthodontics Izmir Çigli

Sponsors (1)

Lead Sponsor Collaborator
Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pre-treatment (T0) cephalometric analysis measures A cephalometric analysis of skeletal maxillary (SNA) and mandibular (SNB) positions 0 month
Primary Pre-treatment (T0) soft tissues measurements Maxillary and mandibular (Soft tissue convexity angle) soft tissue analysis using 3D stereophotogrammetry 0 month
Secondary Post-treatment (T1) cephalometric analysis measurements Evaluation of pos-treatment cephalometric changes of skeletal maxillary (SNA) and mandibular (SNB) positions An average of 6 month
Secondary Post-treatment (T1) soft tissues measurements Evaluation of maxillary and mandibular soft tissue changes (Soft tissue convexity angle) using 3D stereophotogrammetry An average of 6 month
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