ClinicalTrials.gg
Status unknownNCT04863404Updated Apr 28, 2021

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

An interventional study of Face mask with hybrid-hyrax and Face mask with conventional bonded RME in Anterior Crossbite, Class III Malocclusion and Maxillary Deficiency, sponsored by Izmir Katip Celebi University. Status unknown at 1 site in Turkey. Open to participants aged 10 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-28.

Sponsored by Izmir Katip Celebi University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jun 2020, registered Apr 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
10 Years to 13 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Anterior Crossbite
  • Class III Malocclusion
  • Maxillary Deficiency

Keywords

  • maxillary protraction
  • tooth-borne vs bone-anchored
  • face mask
  • AltRamec
  • rme
  • Temporary anchorage devices (TADs) in the anterior palate
  • hybrid hyrax
03

In context

Malocclusion, Angle Class III

57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.

This study's planned enrollment of 42 is above the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.

Browse Malocclusion, Angle Class III studies →

Lead sponsor

Izmir Katip Celebi University is the lead sponsor of 198 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Bone-anchored maxillary protraction group

    Face mask with hybrid-hyrax

    Other: Face mask with hybrid-hyrax

  • Experimental
    Tooth-borne maxillary protraction group

    Face mask with conventional bonded RME

    Other: Face mask with conventional bonded RME

  • No intervention
    Control group

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

Interventions

  • OtherFace mask with hybrid-hyrax

    Face mask with hybrid-hyrax

  • OtherFace mask with conventional bonded RME

    Face mask with conventional bonded RME

06

What researchers measure

Primary outcomes

  1. Pre-treatment (T0) cephalometric analysis measures

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

    Time frame: 0 month

  2. Pre-treatment (T0) soft tissues measurements

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

    Time frame: 0 month

Secondary outcomes

  1. Post-treatment (T1) cephalometric analysis measurements

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

    Time frame: An average of 6 month

  2. Post-treatment (T1) soft tissues measurements

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

    Time frame: An average of 6 month

07

Study locations

1 of 1 sites recruiting
  • Izmir Katip Celebi University,Faculty of Dentistry, Department of Orthodontics
    İzmir, Çiğli 35640, Turkey
    Recruiting
    • Burcin Akan, Phd · Contact
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04863404
Responsible party
Burçin Akan (Assistant Professor, Izmir Katip Celebi University) — Principal investigator
First posted
Apr 28, 2021
Start date
Jun 15, 2020
Primary completion
May 20, 2021 (estimated)
Completion
Oct 20, 2021 (estimated)
Last update
Apr 28, 2021

Study contacts

Burcin AKAN, Phd
Contact
Burcin.yksel@gmail.com
+90 5367103040
Burcin AKAN, Phd
study director · Academician

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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