Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography

NCT06308640 | Active Not Recruiting DMC

• 1 other identifier: ORTH 11-23 2097
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to to evaluate and compare the skeletal and dental changes of bone supported Fast Back and bone supported modified Leaf Spring Self-Activated Expander in bilateral distalization of maxillary molars using CBCT in Egyptian people. The main question it aims to answer are: • If bone supported Fast Back and bone supported modified Leaf Spring Self-Activated Expander will be effective in bilateral distalization of maxillary molars The patients will be selected according to the following criteria:

1. 1.Patient with full permanent dentition.
2. 2.Good oral hygiene.
3. 3.None of the patients had received any orthodontic treatment.
4. 4.Class II molar relationship.
5. 5.Minimal or no crowding in the mandibular arch.
6. 6.Non-extraction treatment plan with molar distalization.
7. 7.Low angle cases.
8. 8.No medical problems or active periodontal disease.

Conditions

Class II Malocclusion

Keywords

Molar Distalization; Fast Back Distalizer; Leaf Spring Self-Activated Expander

Outcome Measures

Primary Outcomes (2)

• 3D Dental and skeletal Cephalometric Measurements

  Using CBCT 3D Analysis

  Through study completion, an average of 1 year"

• 2D Dental and skeletal Cephalometric Measurements

  Using CBCT 2D Analysis

  Through study completion, an average of 1 year"

Study Arms (2)

Fast Back Rapid Distalizer

EXPERIMENTAL

Group 1: Consisted of 10 patients, their upper molar will be distalized with bone suppored Fast Back (Fast Back Rapid Distalizer, leone, s.p.a, Italy).

Device: Insertion of the device intraorally

Modified Leaf Spring Self-Activated Expander

EXPERIMENTAL

Group 2: Consisted of 10 patients, their upper molar will be distalized with bone supported modified Leaf Spring Self-Activated Expander. (Leaf Self Expander, leone, s.p.a, Italy).

Device: Insertion of the device intraorally

Interventions

Insertion of the device intraorally DEVICE

* The distalizer appliance will be checked for adaptation intraorally, the two bands of the maxillary first molars will be fitted in their accurate position on the teeth. * The screw insertion will be carried out with the patient under local anesthesia. * They will be placed inside the two eyelets of the anterior arms of the screw in the appliance

Fast Back Rapid Distalizer; Modified Leaf Spring Self-Activated Expander

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient with full permanent dentition.
• Good oral hygiene.
• Class II molar relationship.
• Non-extraction treatment plan with molar distalization.
• Low angle cases.
• medical problems or active periodontal disease.

You may not qualify if:

• The patients had received any orthodontic treatment.
• Crowding in the mandibular arch.
• Medical problems or active periodontal disease.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry

Tanta, Gharbia Governorate, 6620010, Egypt

Location

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class II; Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Safaa M Gaballah, Professor

  Tanta University

  PRINCIPAL INVESTIGATOR

• Shaimaa M Elmarhoumy, professor

  Tanta University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Lecturer,Orthodontic Department,Faculty of Dentistry

Model Details: The purpose of this study is to evaluate and compare the treatment effects of two bone supported protocols for bilateral distalization of maxillary molars in patients exhibiting class II pattern using Fast Back appliance and modified Leaf Spring Self-Activated Expander

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 13, 2024
• Study Start: January 10, 2024
• Primary Completion: January 10, 2026
• Study Completion: March 10, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

EG (1)