Comparison Between Aesthetic Functional Appliances and Twin Block in Correction of Skeletal Class II

NCT06631235 | Not Yet Recruiting DMC

• 1 other identifier: A04070240R
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this is to evaluate the skeletal, dental and soft tissue effects between aesthetic functional appliance and Twin block appliance in treatment of skeletal class II in ( growing male/female patients)

Conditions

Skeletal Malocclusion

Keywords

classII; mandibular advancement; twin block

Outcome Measures

Primary Outcomes (3)

• skeletal effects

  cephalometric linear and angular measurements

  one year

• dental effects

  cephalometric linear and angular measurements

  one year

• soft tissue effects

  cephalometric linear and angular measurements

  one year

Secondary Outcomes (1)

• root resorption

  one year

Other Outcomes (1)

• CBCT evaluation of TMJ

  one year

Study Arms (2)

twin block group

OTHER

patient treated with twin block appliance

Other: orthopedic appliance

aesthetic functional group

EXPERIMENTAL

patient treated with aesthetic functional appliance

Other: aesthetic orthopedic appliance

Interventions

orthopedic appliance OTHER

appliances are used to correct skeletal class II due to mandibular deficiency

twin block group

aesthetic orthopedic appliance OTHER

aesthetic appliances are used to correct skeletal class II due to mandibular deficiency

aesthetic functional group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Skeletal Class II pattern with ANB angle exceeding 6° and Wits appraisal of 2 mm or more.
• Mandibular deficiency (SNB angle less than 77°).
• Growing patients.
• No prior orthodontic intervention.
• The vertical skeletal classification shows a horizontal or neutral growth pattern.
• Overjet ≥ 8mm.

You may not qualify if:

• Developmental abnormalities with atypical or irregular patterns of growth and maturation.
• Any indications or manifestations, as well as any prior medical records, of Tempro-Mandibular Joint (TMJ) disorders, such as the presence of clicking, pain, limitations, or deviations.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Study Officials

• rana ka Abuzaid, orthodontist

  Egyption orthodontic socity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

rana ka Abuzaid, orthodontist

CONTACT

1009389116; ranaabuzaid52@gmail.com

khaled Ah Awad, surgon

CONTACT

1009297331; khaled_awd2013@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: October 8, 2024
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 21, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2 years
• Access Criteria: mandibular advancement

Locations

EG (1)