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

Class II Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06308640
• Other study ID #: ORTH 11-23 2097
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 10, 2024
• Est. completion date: January 10, 2026

Study information

• Verified date: March 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: January 10, 2026
• Est. primary completion date: January 10, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Class II Malocclusion
• Malocclusion
• Malocclusion, Angle Class II

Intervention

Device:
• 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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3D Dental and skeletal Cephalometric Measurements	Using CBCT 3D Analysis	Through study completion, an average of 1 year"
Primary	2D Dental and skeletal Cephalometric Measurements	Using CBCT 2D Analysis	Through study completion, an average of 1 year"