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

Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04884022
• Other study ID #: Anchored force mechanices
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 13 Years

Eligibility

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).

Related Conditions & MeSH terms

• Malocclusion

Intervention

Procedure:
• Miniplates in mandibular symphysis & infrazygomatic
Fixed functional appliance (pushing orthopedic force) in conjunction with direct skeletal anchorage
• Miniplates in external oblique ridge & anterior maxillary region
Coil spring (pulling orthopedic force) in conjunction with direct skeletal anchorage

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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