Evaluation of the Treatment Effects of Tooth Borne Versus Bone-anchored Protraction Procedures in Class III Patients With Maxillary Deficiency
Primary Purpose
Anterior Crossbite, Class III Malocclusion, Maxillary Deficiency
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Face mask with hybrid-hyrax
Face mask with conventional bonded RME
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Crossbite focused on measuring maxillary protraction, tooth-borne vs bone-anchored, face mask, AltRamec, rme, Temporary anchorage devices (TADs) in the anterior palate, hybrid hyrax
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
Sites / Locations
- Izmir Katip Celebi University,Faculty of Dentistry, Department of OrthodonticsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Bone-anchored maxillary protraction group
Tooth-borne maxillary protraction group
Control group
Arm Description
Face mask with hybrid-hyrax
Face mask with conventional bonded RME
Control group consisting of 14 non-treated Class III malocclusion subjects
Outcomes
Primary Outcome Measures
Pre-treatment (T0) cephalometric analysis measures
A cephalometric analysis of skeletal maxillary (SNA) and mandibular (SNB) positions
Pre-treatment (T0) soft tissues measurements
Maxillary and mandibular (Soft tissue convexity angle) soft tissue analysis using 3D stereophotogrammetry
Secondary Outcome Measures
Post-treatment (T1) cephalometric analysis measurements
Evaluation of pos-treatment cephalometric changes of skeletal maxillary (SNA) and mandibular (SNB) positions
Post-treatment (T1) soft tissues measurements
Evaluation of maxillary and mandibular soft tissue changes (Soft tissue convexity angle) using 3D stereophotogrammetry
Full Information
NCT ID
NCT04863404
First Posted
April 21, 2021
Last Updated
April 27, 2021
Sponsor
Izmir Katip Celebi University
1. Study Identification
Unique Protocol Identification Number
NCT04863404
Brief Title
Evaluation of the Treatment Effects of Tooth Borne Versus Bone-anchored Protraction Procedures in Class III Patients With Maxillary Deficiency
Official Title
Evaluation of the Treatment Effects of Tooth Borne Versus Bone-anchored Protraction Procedures in Class III Patients With Maxillary Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
May 20, 2021 (Anticipated)
Study Completion Date
October 20, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Katip Celebi University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
3 arm parallel clinical trial
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bone-anchored maxillary protraction group
Arm Type
Experimental
Arm Description
Face mask with hybrid-hyrax
Arm Title
Tooth-borne maxillary protraction group
Arm Type
Experimental
Arm Description
Face mask with conventional bonded RME
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group consisting of 14 non-treated Class III malocclusion subjects
Intervention Type
Other
Intervention Name(s)
Face mask with hybrid-hyrax
Intervention Description
Face mask with hybrid-hyrax
Intervention Type
Other
Intervention Name(s)
Face mask with conventional bonded RME
Intervention Description
Face mask with conventional bonded RME
Primary Outcome Measure Information:
Title
Pre-treatment (T0) cephalometric analysis measures
Description
A cephalometric analysis of skeletal maxillary (SNA) and mandibular (SNB) positions
Time Frame
0 month
Title
Pre-treatment (T0) soft tissues measurements
Description
Maxillary and mandibular (Soft tissue convexity angle) soft tissue analysis using 3D stereophotogrammetry
Time Frame
0 month
Secondary Outcome Measure Information:
Title
Post-treatment (T1) cephalometric analysis measurements
Description
Evaluation of pos-treatment cephalometric changes of skeletal maxillary (SNA) and mandibular (SNB) positions
Time Frame
An average of 6 month
Title
Post-treatment (T1) soft tissues measurements
Description
Evaluation of maxillary and mandibular soft tissue changes (Soft tissue convexity angle) using 3D stereophotogrammetry
Time Frame
An average of 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Burcin AKAN, Phd
Phone
+90 5367103040
Email
Burcin.yksel@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burcin AKAN, Phd
Organizational Affiliation
Academician
Official's Role
Study Director
Facility Information:
Facility Name
Izmir Katip Celebi University,Faculty of Dentistry, Department of Orthodontics
City
İzmir
State/Province
Çiğli
ZIP/Postal Code
35640
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burcin Akan, Phd
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Treatment Effects of Tooth Borne Versus Bone-anchored Protraction Procedures in Class III Patients With Maxillary Deficiency
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