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

NCT06308640 | Active Not Recruiting DMC

• 1 other identifier: ORTH 11-23 2097
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.Patient with full permanent dentition.
2. 2.Good oral hygiene.
3. 3.None of the patients had received any orthodontic treatment.
4. 4.Class II molar relationship.
5. 5.Minimal or no crowding in the mandibular arch.
6. 6.Non-extraction treatment plan with molar distalization.
7. 7.Low angle cases.
8. 8.No medical problems or active periodontal disease.

Conditions

Class II Malocclusion

Keywords

Molar Distalization; Fast Back Distalizer; Leaf Spring Self-Activated Expander

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (7)

• Sagittal skeletal parameters

  Through study completion, maximum 18 months.

• Vertical skeletal parameters

  Through study completion, maximum 18 months

• Overjet and overbite

  Through study completion, maximum 18 months

• Vertical position of mesiobuccal and distobuccal cusps of maxillary first molars

  Through study completion, maximum 18 months

• Arch depth and arch perimeter

  Through study completion, maximum 18 months

Study Arms (2)

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).

Device: Fast Back Rapid Distalizer

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)

Device: Modified Leaf Spring Self-Activated Expander

Interventions

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.

Palatally bone supported Fast Back

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.

Palatally bone supported modified Leaf Spring Self-Activated Expander

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• The patients had received any orthodontic treatment.
• Crowding in the mandibular arch.
• Medical problems or active periodontal disease.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry

Tanta, Gharbia Governorate, 6620010, Egypt

Location

Related Publications (1)

• 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.

  PMID: 41814309 DERIVED

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

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

Study Officials

• Safaa M Gaballah, Professor

  Tanta University

  PRINCIPAL INVESTIGATOR

• Shaimaa M Elmarhoumy, professor

  Tanta University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Lecturer,Orthodontic Department,Faculty of Dentistry

Model Details: 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

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 13, 2024
• Study Start: March 10, 2024
• Primary Completion: February 10, 2026
• Study Completion: July 10, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

EG (1)