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

Changes in Arch Parameters After Molar Distalization; Hybrid Hyrax Distalizer Versus Pendulum in Adolescent Class II Patients Prospective Randomized Clinical Study

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Angle Class 2 Malocclusion
• Intervention / Treatment: Device: Hybrid hyrax distalizer; Device: Pendulum distalizer

Detailed Description

Evaluation of maxillary molar amount of distal movement and the amount of anchorage loss Arch length, arch width, arch depth

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo
  • Nasr City
    • Cairo, Nasr City, Egypt, 002
      • Mohamed Shendy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Missed upper first molar.
• un-cooperative patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hybrid hyrax distalizer; Inverted hyrax with 2 miniscrews for 6 months for maxillary molar distal movement in class II angle malocclusion	Device: Hybrid hyrax distalizer; class 2 Angle malocclusion; Device: Pendulum distalizer; class 2 Angle malocclusion
Active Comparator: Pendulum distalizer device; Modified pendulum with miniscrews for 6 months for maxillary molar distal movement in class II angle malocclusion	Device: Hybrid hyrax distalizer; class 2 Angle malocclusion; Device: Pendulum distalizer; class 2 Angle malocclusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nasopharyngeal airway dimensions in Cubic centimeters	CBCT	6 months

Collaborators and Investigators

• Sponsor: Mohamed Abdelrhman Shendy Abdelrhman
• Investigators: Principal Investigator: Mohamed AE Shendy, Lecturer - Orthodontic department -faculty of dental medicine -Al-Azhar university

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Anticipated): November 25, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: hybrid hyrax distalizer; Pendulum distalizer; class II division 1 and 2; molar distalization
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: 824/220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Comparison between two techniques of molar distalization
• IPD Sharing Time Frame: 6 Months
• IPD Sharing Access Criteria: shendy_ortho@azhar.edu.eg
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No