Class II MalocclusionNCT06308640
Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography
A study testing Fast Back Rapid Distalizer and Modified Leaf Spring Self-Activated Expander in people with Class II Malocclusion, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Class II Malocclusion
- What is being tested?
- Fast Back Rapid Distalizer and Modified Leaf Spring Self-Activated Expander
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2024to 10 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- The patients had received any orthodontic treatment.
- Crowding in the mandibular arch.
- Medical problems or active periodontal disease.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- Patient with full permanent dentition.
- Good oral hygiene.
- None of the patients had received any orthodontic treatment.
- Class II molar relationship.
- Minimal or no crowding in the mandibular arch.
- Non-extraction treatment plan with molar distalization.
- Low angle cases.
- 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.
Read the 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.
- Conditions
- Class II Malocclusion
- Being tested
- Fast Back Rapid Distalizer, Modified Leaf Spring Self-Activated Expander
- Keywords
- Molar Distalization, Fast Back Distalizer, Leaf Spring Self-Activated Expander
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast Back Rapid DistalizerDevice
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 ExpanderDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: Device: Modified Leaf Spring Self-Activated Expander |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: Through study completion, maximum 18 months
Secondary outcomes (7)
Sagittal skeletal parameters
Angular measurements including SNA, SNB, ANB, and SN-Pog assessed on CBCT-derived lateral cephalometric views.
Unit of Measure: Degrees
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: Through study completion, maximum 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start10 Mar 2024
- Primary completion10 Feb 2026
- Study completion10 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Class II MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran Mohamed Abdelwahab Eissa, Tanta University
- Investigators
- Safaa M Gaballah, Professor, Principal investigator, Tanta UniversityShaimaa M Elmarhoumy, professor, Study director, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308640
- Sponsor's protocol ID
- ORTH 11-23 2097
- Status last verified
- May 2026
- First submitted
- 29 Feb 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41814309
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography
- ClinicalTrials.gov ID
- NCT06308640
- Acronym / sponsor ID
- ORTH 11-23 2097
- Conditions
- Class II Malocclusion
- Keywords
- Molar Distalization, Fast Back Distalizer, Leaf Spring Self-Activated Expander
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patient with full permanent dentition.
- Good oral hygiene.
- None of the patients had received any orthodontic treatment.
- Class II molar relationship.
- Minimal or no crowding in the mandibular arch.
- Non-extraction treatment plan with molar distalization.
- Low angle cases.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Palatally bone supported Fast Back | Experimental | Device: Fast Back Rapid DistalizerGroup 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). |
| Palatally bone supported modified Leaf Spring Self-Activated Expander | Experimental | Device: Modified Leaf Spring Self-Activated ExpanderGroup 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) |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patient with full permanent dentition.
- Good oral hygiene.
- Class II molar relationship.
- Non-extraction treatment plan with molar distalization.
- Low angle cases.
Key exclusion criteria (3 listed)
- The patients had received any orthodontic treatment.
- Crowding in the mandibular arch.
- Medical problems or active periodontal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast Back Rapid DistalizerThe 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. | Device | Palatally bone supported Fast Back |
| Modified Leaf Spring Self-Activated ExpanderThe 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. | Device | Palatally bone supported modified Leaf Spring Self-Activated Expander |
Primary outcome
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)
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
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
7 secondary outcomes
Sagittal skeletal parameters
Time frame: Through study completion, maximum 18 months.
Vertical skeletal parameters
Time frame: Through study completion, maximum 18 months
Overjet and overbite
Time frame: Through study completion, maximum 18 months
Vertical position of mesiobuccal and distobuccal cusps of maxillary first molars
Time frame: Through study completion, maximum 18 months
Arch depth and arch perimeter
Time frame: Through study completion, maximum 18 months
Axial inclinations of maxillary first molars and first premolars
Time frame: Through study completion, maximum 18 months
Treatment duration
Time frame: Through study completion, maximum 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Derived from this study: PubMed 41814309Elsaharty 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Safaa M Gaballah, Professor principal investigator
Tanta University
Shaimaa M Elmarhoumy, professor study director
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast Back Rapid Distalizer and Modified Leaf Spring Self-Activated Expander in people with Class II Malocclusion, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear distalization of maxillary teeth relative to pterygoid vertical (PTV) plane (time frame: Through study completion, maximum 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06308640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.