Class II Malocclusion
Conditions
Keywords
Molar Distalization, Fast Back Distalizer, Leaf Spring Self-Activated Expander
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.
Interventions
DEVICEFast Back Rapid Distalizer
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.
DEVICEModified Leaf Spring Self-Activated Expander
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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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
Eligibility
Sex/Gender
ALL
Age
14 Years to 18 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Linear distalization of maxillary teeth relative to pterygoid vertical (PTV) plane | Through study completion, maximum 18 months | Distance of maxillary teeth (UR/UL 6, 5, 4, 3, 1) crown tips from PTV plane measured by CBCT. Unit of Measure: Millimeters (mm) |
| Angular inclination of maxillary teeth relative to Frankfort horizontal (FH) plane | Through study completion, maximum 18 months | 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 |
| Molar relationship at end of distalization phase | Through study completion, maximum 18 months | Clinical assessment of bilateral molar relationship categorized as Class I or cusp-to-cusp upon completion of the distalization phase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sagittal skeletal parameters | Through study completion, maximum 18 months. | Angular measurements including SNA, SNB, ANB, and SN-Pog assessed on CBCT-derived lateral cephalometric views. Unit of Measure: Degrees |
| Vertical skeletal parameters | Through study completion, maximum 18 months | 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 |
| Overjet and overbite | Through study completion, maximum 18 months | 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) |
| Vertical position of mesiobuccal and distobuccal cusps of maxillary first molars | Through study completion, maximum 18 months | 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) |
| Arch depth and arch perimeter | Through study completion, maximum 18 months | Linear measurements of maxillary arch depth and arch perimeter assessed on CBCT-derived arch models Unit of Measure: Millimeters (mm) |
| Axial inclinations of maxillary first molars and first premolars | Through study completion, maximum 18 months | 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 |
| Treatment duration | Through study completion, maximum 18 months | Total active distalization period from appliance insertion to achievement of bilateral Class I or cusp-to-cusp molar relationship. Unit of Measure: Months |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORSafaa M Gaballah, Professor
Tanta University
STUDY_DIRECTORShaimaa M Elmarhoumy, professor
Tanta University
Outcome results
None listed