Changes in Arch Parameters After Molar Distalization; Hybrid Hyrax Distalizer Versus Pendulum

NCT05470179 | Enrolling By Invitation

• 1 other identifier: 824/220
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

this study was to compare the changes in arch parameters after molar distalization; hybrid hyrax distalizer versus Pendulum distalizer using CBCT.

Conditions

Angle Class 2 Malocclusion

Keywords

hybrid hyrax distalizer; Pendulum distalizer; class II division 1 and 2; molar distalization

Outcome Measures

Primary Outcomes (2)

• Angles in degree SNA,SNB,ANB, Molar Rotation

  Using cbct and cast

  6 months

• Arch parameters in millimeter Arch length, width,depth and circumference

  Assessment of airway using cbct

  6 Months

Secondary Outcomes (1)

• Nasopharyngeal airway dimensions in Cubic centimeters

  6 months

Study Arms (2)

Hybrid hyrax distalizer

ACTIVE COMPARATOR

Inverted hyrax with 2 miniscrews for 6 months for maxillary molar distal movement in class II angle malocclusion

Device: Hybrid hyrax distalizer; Device: Pendulum distalizer

Pendulum distalizer device

ACTIVE COMPARATOR

Modified pendulum with miniscrews for 6 months for maxillary molar distal movement in class II angle malocclusion

Device: Hybrid hyrax distalizer; Device: Pendulum distalizer

Interventions

Hybrid hyrax distalizer DEVICE

class 2 Angle malocclusion

Hybrid hyrax distalizer; Pendulum distalizer device

Pendulum distalizer DEVICE

class 2 Angle malocclusion

Hybrid hyrax distalizer; Pendulum distalizer device

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• For group 1(Hybrid hyrax distalizer) Patients suffering maxillary collapse with a skeletal background with unilateral or bilateral posterior crossbite.
• For group 2 (Pendulum distalizer) Patients with skeletal class I or class II malocclusion who needed upper first and second molar distalization for incisor retraction or relieving of the upper arch crowding and minimum or no crowding in lower jaw were selected.
• All Patients had no systemic diseases that may affect bone quality or interfere with orthodontic treatment, periodontal disease and no previous orthodontic treatment.
• Age range was 13 to 17 years.

You may not qualify if:

• Missed upper first molar.
• un-cooperative patient

Sponsors & Collaborators

• Mohamed Abdelrhman Shendy Abdelrhman: lead

Study Sites (2)

Mohamed Shendy

Cairo, Nasr City, 002, Egypt

Location

Cairo

Cairo, Egypt

Location

Related Publications (2)

• Bishara SE, Staley RN. Maxillary expansion: clinical implications. Am J Orthod Dentofacial Orthop. 1987 Jan;91(1):3-14. doi: 10.1016/0889-5406(87)90202-2.

  PMID: 3541577 BACKGROUND

• Haas AJ. Palatal expansion: just the beginning of dentofacial orthopedics. Am J Orthod. 1970 Mar;57(3):219-55. doi: 10.1016/0002-9416(70)90241-1. No abstract available.

  PMID: 5263785 BACKGROUND

Study Officials

• Mohamed AE Shendy

  Lecturer - Orthodontic department -faculty of dental medicine -Al-Azhar university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 22, 2022
• Study Start: May 10, 2022
• Primary Completion: November 25, 2022
• Study Completion: July 30, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 6 Months
• Access Criteria: shendy\ ortho@azhar.edu.eg

Locations

EG (2)