Effectiveness of Two Skeletally Anchored Force Mechanics for Skeletal Class II Correction in Growing Patients
Primary Purpose
Malocclusion
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Miniplates in mandibular symphysis & infrazygomatic
Miniplates in external oblique ridge & anterior maxillary region
Sponsored by
About this trial
This is an interventional treatment trial for Malocclusion
Eligibility Criteria
Inclusion Criteria:
- Chronological age ranges from 11 years to 13 years.
- Skeletal Class II malocclusion with a deficient mandible (SNB ≤ 76°).
- Horizontal growth pattern (MP/SN ≤ 39°).
- Angle Class II division 1 malocclusion with at least 5 mm overjet.
- Mandibular arch crowding less than 5 mm.
- The patients have to be in the prepubertal growth stage (cervical maturational stage 3 or 4) when applying orthopedic force.
- Patients with good oral hygiene, and a healthy periodontal condition.
Exclusion Criteria:
- Patients who underwent previous orthodontic treatment.
- Patients with previous craniofacial surgeries, chronic diseases, syndromes, or growth problems that may affect bone.
- Any signs or symptoms of para-functional habits or previous history of temporomandibular disorders.
- Extracted or missing upper permanent teeth (except for third molars).
Sites / Locations
- Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Miniplates in mandibular symphysis & infrazygomatic
Miniplates in external oblique ridge & anterior maxillary region
Growing skeletal Class II subjects
Arm Description
Outcomes
Primary Outcome Measures
change in the effective mandibular length (Co-Gn)
Correction of the skeletal Class II relation. This outcome will be detected by measuring the mean change in the effective mandibular length (Co-Gn) and position on CBCT images from baseline data (T1) and after appliance removal (T2) and will be compared with the growth changes observed in the control group
Secondary Outcome Measures
change in maxillary length (Co-A)
The effective maxillary length (Co-A) and position changes will be measured after and chin will be measured.
Changes in the soft tissue angle of convexity
the position of the upper and lower lips, and chin will be measured.
patient acceptance of treatment
The patient's acceptance to the treatment will be evaluated using a visual analog scale questionnaire after removal of the appliances.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04884022
Brief Title
Effectiveness of Two Skeletally Anchored Force Mechanics for Skeletal Class II Correction in Growing Patients
Official Title
Effectiveness of Two Skeletally Anchored Force Mechanics for Correction of Skeletal Class II Malocclusion in Growing Patients (A Randomized Controlled Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with skeletal Class II malocclusion due to mandibular retrognathism will be recruited and randomly allocated to three equal groups. first group will be treated by pushing orthopedic force mechanics, second group will be treated by pulling orthopedic force mechanics, and third group will be observed for 9 months to detect the natural growth changes. Skeletal changes will be evaluated and the treatment changes will be compared with the natural growth changes. The study hypothesis is that use of direct bimaxillary miniplate anchorage in conjunction with fixed functional appliance (pushing orthopedic force) or closed coil spring (pulling orthopedic force) will induce statistically significant skeletal mandibular growth in comparison to natural mandibular growth changes.
Detailed Description
A randomized controlled clinical trial will be conducted to address the aim of the study. Thirty-nine growing patients with skeletal Class II malocclusion due to mandibular retrognathism will be recruited. The sample will be randomly allocated to three equal groups, each including thirteen subjects. Group A will be treated by pushing orthopedic force mechanics using fixed functional appliance (Sabbagh Advanced Repositioning Appliance) anchored to four miniplates (two miniplates inserted in the mandibular symphysis and two infrazygomatic miniplates), and Group B, will be treated by pulling orthopedic force mechanics using Class II springs (CS Class II correction device) anchored to four miniplates (two inserted in the mandibular posterior buccal segment and two inserted in the maxillary anterior segment). In both groups, the appliances will be removed after reaching an edge-to-edge incisor relationship or after 9 months, whichever happens first. A similar third group (Group C) will be observed for 9 months to detect the natural growth changes. Skeletal changes will be evaluated using pretreatment and posttreatment cone beam computed tomography scans (CBCT). The treatment changes will be compared with the natural growth changes observed in group C. Other variables will be also examined including, the dentoalveolar effects, the soft tissue profile, and the patient's acceptance to this treatment modality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Miniplates in mandibular symphysis & infrazygomatic
Arm Type
Experimental
Arm Title
Miniplates in external oblique ridge & anterior maxillary region
Arm Type
Active Comparator
Arm Title
Growing skeletal Class II subjects
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Miniplates in mandibular symphysis & infrazygomatic
Intervention Description
Fixed functional appliance (pushing orthopedic force) in conjunction with direct skeletal anchorage
Intervention Type
Procedure
Intervention Name(s)
Miniplates in external oblique ridge & anterior maxillary region
Intervention Description
Coil spring (pulling orthopedic force) in conjunction with direct skeletal anchorage
Primary Outcome Measure Information:
Title
change in the effective mandibular length (Co-Gn)
Description
Correction of the skeletal Class II relation. This outcome will be detected by measuring the mean change in the effective mandibular length (Co-Gn) and position on CBCT images from baseline data (T1) and after appliance removal (T2) and will be compared with the growth changes observed in the control group
Time Frame
at baseline and after treatment completion about 9 months
Secondary Outcome Measure Information:
Title
change in maxillary length (Co-A)
Description
The effective maxillary length (Co-A) and position changes will be measured after and chin will be measured.
Time Frame
at baseline and after treatment completion about 9 months
Title
Changes in the soft tissue angle of convexity
Description
the position of the upper and lower lips, and chin will be measured.
Time Frame
at baseline and after treatment completion about 9 months
Title
patient acceptance of treatment
Description
The patient's acceptance to the treatment will be evaluated using a visual analog scale questionnaire after removal of the appliances.
Time Frame
After treatment completion about 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronological age ranges from 11 years to 13 years.
Skeletal Class II malocclusion with a deficient mandible (SNB ≤ 76°).
Horizontal growth pattern (MP/SN ≤ 39°).
Angle Class II division 1 malocclusion with at least 5 mm overjet.
Mandibular arch crowding less than 5 mm.
The patients have to be in the prepubertal growth stage (cervical maturational stage 3 or 4) when applying orthopedic force.
Patients with good oral hygiene, and a healthy periodontal condition.
Exclusion Criteria:
Patients who underwent previous orthodontic treatment.
Patients with previous craniofacial surgeries, chronic diseases, syndromes, or growth problems that may affect bone.
Any signs or symptoms of para-functional habits or previous history of temporomandibular disorders.
Extracted or missing upper permanent teeth (except for third molars).
Facility Information:
Facility Name
Faculty of Dentistry
City
Alexandria
ZIP/Postal Code
21526
Country
Egypt
12. IPD Sharing Statement
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Effectiveness of Two Skeletally Anchored Force Mechanics for Skeletal Class II Correction in Growing Patients
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