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 (Other)
Overall Status
Recruiting
CT.gov ID
NCT04863404
Collaborator
(none)
42
1
3
16.2
2.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Face mask with hybrid-hyrax
  • Other: Face mask with conventional bonded RME
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
3 arm parallel clinical trial
Primary Purpose:
Treatment
Official Title:
Evaluation of the Treatment Effects of Tooth Borne Versus Bone-anchored Protraction Procedures in Class III Patients With Maxillary Deficiency
Actual Study Start Date :
Jun 15, 2020
Anticipated Primary Completion Date :
May 20, 2021
Anticipated Study Completion Date :
Oct 20, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Pre-treatment (T0) cephalometric analysis measures [0 month]

    A cephalometric analysis of skeletal maxillary (SNA) and mandibular (SNB) positions

  2. Pre-treatment (T0) soft tissues measurements [0 month]

    Maxillary and mandibular (Soft tissue convexity angle) soft tissue analysis using 3D stereophotogrammetry

Secondary Outcome Measures

  1. Post-treatment (T1) cephalometric analysis measurements [An average of 6 month]

    Evaluation of pos-treatment cephalometric changes of skeletal maxillary (SNA) and mandibular (SNB) positions

  2. Post-treatment (T1) soft tissues measurements [An average of 6 month]

    Evaluation of maxillary and mandibular soft tissue changes (Soft tissue convexity angle) using 3D stereophotogrammetry

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 13 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Izmir Katip Celebi University,Faculty of Dentistry, Department of Orthodontics İzmir Çiğli Turkey 35640

Sponsors and Collaborators

  • Izmir Katip Celebi University

Investigators

  • Study Director: Burcin AKAN, Phd, Academician

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Burçin Akan, Assistant Professor, Izmir Katip Celebi University
ClinicalTrials.gov Identifier:
NCT04863404
Other Study ID Numbers:
  • 2021-TDU-DİŞF-0003
First Posted:
Apr 28, 2021
Last Update Posted:
Apr 28, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Burçin Akan, Assistant Professor, Izmir Katip Celebi University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2021