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NCT Number: NCT06308640

Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Class II Malocclusion Malocclusion Malocclusion, Angle Class II Overbite Stomatognathic Diseases Tooth Diseases

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Tanta, Gharbia Governorate, 6620010, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Linear distalization of maxillary teeth relative to pterygoid vertical (PTV) plane

    Time frame: 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)

  2. Angular inclination of maxillary teeth relative to Frankfort horizontal (FH) plane

    Time frame: 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

  3. Molar relationship at end of distalization phase

    Time frame: 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 outcomes

  1. Sagittal skeletal parameters

    Time frame: 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

  2. Vertical skeletal parameters

    Time frame: 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

  3. Overjet and overbite

    Time frame: 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)

  4. Vertical position of mesiobuccal and distobuccal cusps of maxillary first molars

    Time frame: 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)

  5. Arch depth and arch perimeter

    Time frame: 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)

  6. Axial inclinations of maxillary first molars and first premolars

    Time frame: 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

  7. Treatment duration

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2024
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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