Clinical trial NCT06308640: Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography
Official title: Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Class II Malocclusion
Keywords: Molar Distalization
Fast Back Distalizer
Leaf Spring Self-Activated Expander
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 3D Dental and skeletal Cephalometric Measurements
timeFrame: Through study completion, an average of 1 year"
measure: 2D Dental and skeletal Cephalometric Measurements
timeFrame: Through study completion, an average of 1 year"
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Dentistry
state: Gharbia
Study officials:
affiliation: Tanta University
name: Safaa M Gaballah, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University
name: Shaimaa M Elmarhoumy, professor
role: STUDY_DIRECTOR
References: