Evaluation of the Treatment Effects of Tooth Borne Versus Bone-anchored Protraction Procedures in Class III Patients With Maxillary Deficiency

NCT ID: NCT04863404

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2021-10-20

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.

Conditions

Anterior Crossbite; Class III Malocclusion; Maxillary Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bone-anchored maxillary protraction group

Face mask with hybrid-hyrax

Group Type: EXPERIMENTAL

Face mask with hybrid-hyrax

Intervention Type: OTHER

Face mask with hybrid-hyrax

Tooth-borne maxillary protraction group

Face mask with conventional bonded RME

Group Type: EXPERIMENTAL

Face mask with conventional bonded RME

Intervention Type: OTHER

Face mask with conventional bonded RME

Control group

Control group consisting of 14 non-treated Class III malocclusion subjects

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Face mask with hybrid-hyrax

Face mask with hybrid-hyrax

Intervention Type: OTHER

Face mask with conventional bonded RME

Face mask with conventional bonded RME

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Izmir Katip Celebi University

OTHER

Sponsor Role: lead

Responsible Party

Burçin Akan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Burcin AKAN, Phd

Role: STUDY_DIRECTOR

Academician

Locations

Izmir Katip Celebi University,Faculty of Dentistry, Department of Orthodontics

Izmir, Çiğli, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Burcin AKAN, Phd

Role: CONTACT

Burcin.yksel@gmail.com

+90 5367103040

Facility Contacts

Burcin Akan, Phd

Role: primary

Other Identifiers

2021-TDU-DİŞF-0003

Identifier Type: -

Identifier Source: org_study_id