Effectiveness of Two Skeletally Anchored Force Mechanics for Skeletal Class II Correction in Growing Patients

Effectiveness of Two Skeletally Anchored Force Mechanics for Correction of Skeletal Class II Malocclusion in Growing Patients (A Randomized Controlled Clinical Trial)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malocclusion
• Intervention / Treatment: Procedure: Miniplates in mandibular symphysis & infrazygomatic; Procedure: Miniplates in external oblique ridge & anterior maxillary region

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.

• Study Type: Interventional
• Enrollment (Anticipated): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21526
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Miniplates in mandibular symphysis & infrazygomatic	Procedure: Miniplates in mandibular symphysis & infrazygomatic; Fixed functional appliance (pushing orthopedic force) in conjunction with direct skeletal anchorage
Active Comparator: Miniplates in external oblique ridge & anterior maxillary region	Procedure: Miniplates in external oblique ridge & anterior maxillary region; Coil spring (pulling orthopedic force) in conjunction with direct skeletal anchorage
No Intervention: Growing skeletal Class II subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at baseline and after treatment completion about 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in maxillary length (Co-A)	The effective maxillary length (Co-A) and position changes will be measured after and chin will be measured.	at baseline and after treatment completion about 9 months
Changes in the soft tissue angle of convexity	the position of the upper and lower lips, and chin will be measured.	at baseline and after treatment completion about 9 months
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.	After treatment completion about 9 months

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 24, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: Anchored force mechanices

Drug and device information, study documents

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