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

Primary Purpose

Angle Class 2 Malocclusion

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Hybrid hyrax distalizer

Pendulum distalizer

About this trial

This is an interventional treatment trial for Angle Class 2 Malocclusion focused on measuring hybrid hyrax distalizer, Pendulum distalizer, class II division 1 and 2, molar distalization

Eligibility Criteria

13 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Mohamed Shendy
Cairo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Hybrid hyrax distalizer

Pendulum distalizer device

Arm Description

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

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

Outcomes

Primary Outcome Measures

Angles in degree SNA,SNB,ANB, Molar Rotation

Using cbct and cast

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

Assessment of airway using cbct

Secondary Outcome Measures

Nasopharyngeal airway dimensions in Cubic centimeters

CBCT

Full Information

NCT ID

NCT05470179

First Posted

July 4, 2022

Last Updated

February 1, 2023

Sponsor

Mohamed Abdelrhman Shendy Abdelrhman

1. Study Identification

Unique Protocol Identification Number

NCT05470179

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

May 10, 2022 (Actual)

Primary Completion Date

November 25, 2022 (Actual)

Study Completion Date

July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mohamed Abdelrhman Shendy Abdelrhman

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Angle Class 2 Malocclusion

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hybrid hyrax distalizer

Arm Type

Active Comparator

Arm Description

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

Arm Title

Pendulum distalizer device

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Hybrid hyrax distalizer

Intervention Description

class 2 Angle malocclusion

Intervention Type

Device

Intervention Name(s)

Pendulum distalizer

Intervention Description

class 2 Angle malocclusion

Primary Outcome Measure Information:

Title

Angles in degree SNA,SNB,ANB, Molar Rotation

Description

Using cbct and cast

Time Frame

6 months

Title

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

Description

Assessment of airway using cbct

Time Frame

6 Months

Secondary Outcome Measure Information:

Title

Nasopharyngeal airway dimensions in Cubic centimeters

Description

CBCT

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed AE Shendy

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mohamed Shendy

City

Cairo

State/Province

Nasr City

ZIP/Postal Code

002

Country

Egypt

Facility Name

Cairo

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Comparison between two techniques of molar distalization

IPD Sharing Time Frame

6 Months

IPD Sharing Access Criteria

shendy_ortho@azhar.edu.eg

Citations:

PubMed Identifier

3541577

Citation

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.

Results Reference

background

PubMed Identifier

5263785

Citation

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.

Results Reference

background

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

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