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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:
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).
All data will be collected, tabulated and statistically analyzed using the SPSS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palatally bone supported Fast Back | Experimental | 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). |
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| Palatally bone supported modified Leaf Spring Self-Activated Expander | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fast Back Rapid Distalizer | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | 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 | Through study completion, maximum 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sagittal skeletal parameters | Angular measurements including SNA, SNB, ANB, and SN-Pog assessed on CBCT-derived lateral cephalometric views. Unit of Measure: Degrees | Through study completion, maximum 18 months. |
| Vertical skeletal parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Safaa M Gaballah, Professor | Tanta University | Principal Investigator |
| Shaimaa M Elmarhoumy, professor | Tanta University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry | Tanta | Gharbia Governorate | 6620010 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41814309 | Derived | Elsaharty M, Abo-Elmahasen MMF, Eissa NM, Elbialy M. Efficacy of skeletally anchored modified leaf expander versus modified conventional Hyrax in maxillary molar distalization: a randomized clinical trial. BMC Oral Health. 2026 Mar 11;26(1):482. doi: 10.1186/s12903-026-07836-3. |
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| ID | Term |
|---|---|
| D057887 | Overbite |
| ID | Term |
|---|---|
| D008312 | Malocclusion, Angle Class II |
| D008310 | Malocclusion |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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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
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| Modified Leaf Spring Self-Activated Expander | Device | 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. |
|
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
| 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) | 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) | 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) | 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 | 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 | Through study completion, maximum 18 months |