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

NCT ID: NCT06308640

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-10
• Study Completion Date: 2026-03-10

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. Patient with full permanent dentition.

2. Good oral hygiene.

3. None of the patients had received any orthodontic treatment.

4. Class II molar relationship.

5. Minimal or no crowding in the mandibular arch.

6. Non-extraction treatment plan with molar distalization.

7. Low angle cases.

8. No medical problems or active periodontal disease.

Researchers will compare between bone supported Fast Back appliance and bone supported modified Leaf Spring Self-Activated and see if they will be effective in maxillary molars distalization.

Detailed Description

The patients will be divided into two groups:

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).

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).

• Assessment of the 3D dentoskeletal treatment effects of the palatally bone supported Fast Back and palatally bone supported modified Leaf Spring Self-Activated Expander will be performed by using the CBCT scans.
• Pretreatment CBCT (T1) and post-distalization until study completion with an average of 1 year (T2) for each subject

All data will be collected, tabulated and statistically analyzed using the SPSS.

Conditions

Class II Malocclusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fast Back Rapid Distalizer

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).

Group Type: EXPERIMENTAL

Insertion of the device intraorally

Intervention Type: 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

Modified Leaf Spring Self-Activated Expander

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).

Group Type: EXPERIMENTAL

Insertion of the device intraorally

Intervention Type: 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

Interventions

Insertion of the device intraorally

• 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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Nouran Mohamed Abdelwahab Eissa

Assisstant Lecturer,Orthodontic Department,Faculty of Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Safaa M Gaballah, Professor

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Shaimaa M Elmarhoumy, professor

Role: STUDY_DIRECTOR

Tanta University

Locations

Faculty of Dentistry

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

Other Identifiers

ORTH 11-23 2097

Identifier Type: -

Identifier Source: org_study_id