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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
The Fast Back Rapid Distalizer (Leone S.p.A., Italy) was inserted intraorally following molar band cementation. Two palatal miniscrews (2.0 × 13 mm) were placed under local anesthesia and engaged into the eyelets of the anterior arms of the appliance to provide skeletal anchorage. The appliance was reactivated monthly (one turn per side) until bilateral Class I or cusp-to-cusp molar relationship was achieved.
The Modified Leaf Spring Self-Activated Expander (Leaf Self Expander, Leone S.p.A., Italy) was inserted intraorally following molar band cementation. Two palatal miniscrews (2.0 × 13 mm) were placed under local anesthesia and engaged into the eyelets of the anterior arms of the appliance. Upon insertion, the two retaining staples were removed to activate the superelastic NiTi leaf springs. No further reactivation was required throughout treatment.
Faculty of Dentistry
Tanta, Gharbia Governorate, Egypt
Linear distalization of maxillary teeth relative to pterygoid vertical (PTV) plane
Distance of maxillary teeth (UR/UL 6, 5, 4, 3, 1) crown tips from PTV plane measured by CBCT. Unit of Measure: Millimeters (mm)
Time frame: Through study completion, maximum 18 months
Angular inclination of maxillary teeth relative to Frankfort horizontal (FH) plane
Inclination of long axis of maxillary teeth (UR/UL 6, 5, 4, 3, 1) relative to FH plane measured by CBCT Unit of Measure: Degrees
Time frame: Through study completion, maximum 18 months
Molar relationship at end of distalization phase
Clinical assessment of bilateral molar relationship categorized as Class I or cusp-to-cusp upon completion of the distalization phase
Time frame: Through study completion, maximum 18 months
Sagittal skeletal parameters
Angular measurements including SNA, SNB, ANB, and SN-Pog assessed on CBCT-derived lateral cephalometric views. Unit of Measure: Degrees
Time frame: Through study completion, maximum 18 months.
Vertical skeletal parameters
Angular and linear measurements including SN-MP, FH-MP, LAFH, TAFH, PFH, LAFH/TAFH ratio, and PFH/TAFH ratio assessed on CBCT-derived lateral cephalometric views Unit of Measure: Degrees and millimeters
Time frame: Through study completion, maximum 18 months
Overjet and overbite
Horizontal and vertical overlap of maxillary and mandibular incisors measured clinically at baseline (T1) and end of distalization phase (T2) Unit of Measure: Millimeters (mm)
Time frame: Through study completion, maximum 18 months
Vertical position of mesiobuccal and distobuccal cusps of maxillary first molars
Heights of mesiobuccal (MBU R6, MBU L6) and distobuccal (DBU R6, DBU L6) cusps of maxillary first molars relative to Frankfort horizontal plane measured by CBCT Unit of Measure: Millimeters (mm)
Time frame: Through study completion, maximum 18 months
Arch depth and arch perimeter
Linear measurements of maxillary arch depth and arch perimeter assessed on CBCT-derived arch models Unit of Measure: Millimeters (mm)
Time frame: Through study completion, maximum 18 months
Axial inclinations of maxillary first molars and first premolars
Axial angular measurements of maxillary right and left first molars (UR6, UL6) and first premolars (UR4, UL4) in the axial plane measured by CBCT Unit of Measure: Degrees
Time frame: Through study completion, maximum 18 months
Treatment duration
Total active distalization period from appliance insertion to achievement of bilateral Class I or cusp-to-cusp molar relationship. Unit of Measure: Months
Time frame: Through study completion, maximum 18 months
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