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

NCT04884022 | Unknown DMC

• 1 other identifier: Anchored force mechanices
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• change in maxillary length (Co-A)

  at baseline and after treatment completion about 9 months

• Changes in the soft tissue angle of convexity

  at baseline and after treatment completion about 9 months

• patient acceptance of treatment

  After treatment completion about 9 months

Study Arms (3)

Miniplates in mandibular symphysis & infrazygomatic

EXPERIMENTAL

Procedure: Miniplates in mandibular symphysis & infrazygomatic

Miniplates in external oblique ridge & anterior maxillary region

ACTIVE COMPARATOR

Procedure: Miniplates in external oblique ridge & anterior maxillary region

Growing skeletal Class II subjects

NO INTERVENTION

Interventions

Miniplates in mandibular symphysis & infrazygomatic PROCEDURE

Fixed functional appliance (pushing orthopedic force) in conjunction with direct skeletal anchorage

Miniplates in mandibular symphysis & infrazygomatic

Miniplates in external oblique ridge & anterior maxillary region PROCEDURE

Coil spring (pulling orthopedic force) in conjunction with direct skeletal anchorage

Miniplates in external oblique ridge & anterior maxillary region

Eligibility Criteria

• Age: 11 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry

Alexandria, 21526, Egypt

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical researcher

Study Record Dates

• First Submitted: April 24, 2021
• First Posted: May 12, 2021
• Study Start: March 8, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

EG (1)