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

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.

Study Overview

• Status: Recruiting
• Conditions: Class III Malocclusion; Anterior Crossbite; Maxillary Deficiency
• Intervention / Treatment: Other: Face mask with hybrid-hyrax; Other: Face mask with conventional bonded RME

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 Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Burcin AKAN, Phd; Phone Number: +90 5367103040; Email: Burcin.yksel@gmail.com

Study Locations

• Turkey
  • Çiğli
    • İzmir, Çiğli, Turkey, 35640
      • Recruiting
      • Izmir Katip Celebi University,Faculty of Dentistry, Department of Orthodontics
      • Contact: Burcin Akan, Phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bone-anchored maxillary protraction group; Face mask with hybrid-hyrax	Other: Face mask with hybrid-hyrax; Face mask with hybrid-hyrax
Experimental: Tooth-borne maxillary protraction group; Face mask with conventional bonded RME	Other: Face mask with conventional bonded RME; Face mask with conventional bonded RME
No Intervention: Control group; Control group consisting of 14 non-treated Class III malocclusion subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-treatment (T0) cephalometric analysis measures	A cephalometric analysis of skeletal maxillary (SNA) and mandibular (SNB) positions	0 month
Pre-treatment (T0) soft tissues measurements	Maxillary and mandibular (Soft tissue convexity angle) soft tissue analysis using 3D stereophotogrammetry	0 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University
• Investigators: Study Director: Burcin AKAN, Phd, Academician

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Anticipated): May 20, 2021
• Study Completion (Anticipated): October 20, 2021

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: face mask; maxillary protraction; tooth-borne vs bone-anchored; AltRamec; rme; Temporary anchorage devices (TADs) in the anterior palate; hybrid hyrax
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Malocclusion; Prognathism; Malocclusion, Angle Class III; Micrognathism
• Other Study ID Numbers: 2021-TDU-DİŞF-0003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No