Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 3D Dental and skeletal Cephalometric Measurements
Study Overview
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:
- Patient with full permanent dentition.
- Good oral hygiene.
- None of the patients had received any orthodontic treatment.
- Class II molar relationship.
- Minimal or no crowding in the mandibular arch.
- Non-extraction treatment plan with molar distalization.
- Low angle cases.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 14 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Palatally bone supported modified Leaf Spring Self-Activated Expander
Group II : 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)
Intervention: Modified Leaf Spring Self-Activated Expander (Device)
Palatally bone supported Fast Back
Group I : Consisted of 10 patients, their upper molar will be distalized with bone supported Fast Back (Fast Back Rapid Distalizer, leone, s.p.a, Italy).
Intervention: Fast Back Rapid Distalizer (Device)
Outcomes
Primary Outcomes
3D Dental and skeletal Cephalometric Measurements
Time Frame: Through study completion, an average of 1 year"
Using CBCT 3D Analysis
2D Dental and skeletal Cephalometric Measurements
Time Frame: Through study completion, an average of 1 year"
Using CBCT 2D Analysis
Secondary Outcomes
No secondary outcomes reported
Investigators
Nouran Mohamed Abdelwahab Eissa
Assisstant Lecturer,Orthodontic Department,Faculty of Dentistry
Tanta University