Angle Class 2 MalocclusionNCT05470179
Changes in Arch Parameters After Molar Distalization; Hybrid Hyrax Distalizer Versus Pendulum
A study testing Hybrid hyrax distalizer and Pendulum distalizer in people with Angle Class 2 Malocclusion, run by Mohamed Abdelrhman Shendy Abdelrhman at 2 sites in Egypt.
Trial summary
this study was to compare the changes in arch parameters after molar distalization; hybrid hyrax distalizer versus Pendulum distalizer using CBCT. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Angle Class 2 Malocclusion
- What is being tested?
- Hybrid hyrax distalizer and Pendulum distalizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 May 2022to 30 Jul 2024
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For group 1(Hybrid hyrax distalizer) Patients suffering maxillary collapse with a skeletal background with unilateral or bilateral posterior crossbite.
- For group 2 (Pendulum distalizer) Patients with skeletal class I or class II malocclusion who needed upper first and second molar distalization for incisor retraction or relieving of the upper arch crowding and minimum or no crowding in lower jaw were selected.
- All Patients had no systemic diseases that may affect bone quality or interfere with orthodontic treatment, periodontal disease and no previous orthodontic treatment.
- Age range was 13 to 17 years.
Who cannot join
- Missed upper first molar.
- un-cooperative patient
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Changes in Arch Parameters After Molar Distalization; Hybrid Hyrax Distalizer Versus Pendulum in Adolescent Class II Patients Prospective Randomized Clinical Study
this study was to compare the changes in arch parameters after molar distalization; hybrid hyrax distalizer versus Pendulum distalizer using CBCT.
Read the detailed description
Evaluation of maxillary molar amount of distal movement and the amount of anchorage loss Arch length, arch width, arch depth
- Conditions
- Angle Class 2 Malocclusion
- Being tested
- Hybrid hyrax distalizer, Pendulum distalizer
- Keywords
- hybrid hyrax distalizer, Pendulum distalizer, class II division 1 and 2, molar distalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid hyrax distalizerDevice
class 2 Angle malocclusion
Pendulum distalizerDevice
class 2 Angle malocclusion
| Study group | Role | What they receive |
|---|---|---|
| Hybrid hyrax distalizer | Active comparator | Inverted hyrax with 2 miniscrews for 6 months for maxillary molar distal movement in class II angle malocclusion Receives: Device: Hybrid hyrax distalizer; Device: Pendulum distalizer |
| Pendulum distalizer device | Active comparator | Modified pendulum with miniscrews for 6 months for maxillary molar distal movement in class II angle malocclusion Receives: Device: Hybrid hyrax distalizer; Device: Pendulum distalizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angles in degree SNA,SNB,ANB, Molar Rotation
Using cbct and cast
Measured: 6 months
Arch parameters in millimeter Arch length, width,depth and circumference
Assessment of airway using cbct
Measured: 6 Months
Secondary outcomes (1)
Nasopharyngeal airway dimensions in Cubic centimeters
CBCT
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start10 May 2022
- Primary completion25 Nov 2022
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Angle Class 2 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Abdelrhman Shendy Abdelrhman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Abdelrhman Shendy Abdelrhman, Al-Azhar University
- Investigators
- Mohamed AE Shendy, Principal investigator, Lecturer - Orthodontic department -faculty of dental medicine -Al-Azhar university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470179
- Sponsor's protocol ID
- 824/220
- Status last verified
- May 2024
- First submitted
- 4 Jul 2022
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Comparison between two techniques of molar distalization
Publications
Bishara SE, Staley RN. Maxillary expansion: clinical implications. Am J Orthod Dentofacial Orthop. 1987 Jan;91(1):3-14. doi: 10.1016/0889-5406(87)90202-2.
PubMed 3541577Haas AJ. Palatal expansion: just the beginning of dentofacial orthopedics. Am J Orthod. 1970 Mar;57(3):219-55. doi: 10.1016/0002-9416(70)90241-1. No abstract available.
PubMed 5263785
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Arch Parameters After Molar Distalization; Hybrid Hyrax Distalizer Versus Pendulum in Adolescent Class II Patients Prospective Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05470179
- Acronym / sponsor ID
- 824/220
- Conditions
- Angle Class 2 Malocclusion
- Keywords
- hybrid hyrax distalizer, Pendulum distalizer, class II division 1 and 2, molar distalization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mohamed Abdelrhman Shendy AbdelrhmanUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 22 Jul 2022 (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.
this study was to compare the changes in arch parameters after molar distalization; hybrid hyrax distalizer versus Pendulum distalizer using CBCT.
Detailed description
Evaluation of maxillary molar amount of distal movement and the amount of anchorage loss Arch length, arch width, arch depth
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid hyrax distalizer | Active comparator | Device: Hybrid hyrax distalizer, Device: Pendulum distalizerInverted hyrax with 2 miniscrews for 6 months for maxillary molar distal movement in class II angle malocclusion |
| Pendulum distalizer device | Active comparator | Device: Hybrid hyrax distalizer, Device: Pendulum distalizerModified pendulum with miniscrews for 6 months for maxillary molar distal movement in class II angle malocclusion |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- For group 1(Hybrid hyrax distalizer) Patients suffering maxillary collapse with a skeletal background with unilateral or bilateral posterior crossbite.
- For group 2 (Pendulum distalizer) Patients with skeletal class I or class II malocclusion who needed upper first and second molar distalization for incisor retraction or relieving of the upper arch crowding and minimum or no crowding in lower jaw were selected.
- All Patients had no systemic diseases that may affect bone quality or interfere with orthodontic treatment, periodontal disease and no previous orthodontic treatment.
- Age range was 13 to 17 years.
Key exclusion criteria (2 listed)
- Missed upper first molar.
- un-cooperative patient
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 |
|---|---|---|
| Hybrid hyrax distalizerclass 2 Angle malocclusion | Device | Hybrid hyrax distalizer, Pendulum distalizer device |
| Pendulum distalizerclass 2 Angle malocclusion | Device | Hybrid hyrax distalizer, Pendulum distalizer device |
Primary outcome
Angles in degree SNA,SNB,ANB, Molar Rotation
Time frame: 6 months
Using cbct and cast
Arch parameters in millimeter Arch length, width,depth and circumference
Time frame: 6 Months
Assessment of airway using cbct
1 secondary outcome
Nasopharyngeal airway dimensions in Cubic centimeters
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Background: PubMed 3541577Bishara SE, Staley RN. Maxillary expansion: clinical implications. Am J Orthod Dentofacial Orthop. 1987 Jan;91(1):3-14. doi: 10.1016/0889-5406(87)90202-2.
- Background: PubMed 5263785Haas AJ. Palatal expansion: just the beginning of dentofacial orthopedics. Am J Orthod. 1970 Mar;57(3):219-55. doi: 10.1016/0002-9416(70)90241-1. No abstract available.
- Individual participant dataSharing planned: Yes. Comparison between two techniques of molar distalization
Related trials for Angle Class 2 Malocclusion
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Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
Class II Malocclusion
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Malocclusion, Angle Class II, Malocclusion, Angle Class III
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Treatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates
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Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
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Recruiting
Effect of Early Versus Late Premolar Extraction on Orthodontic Tooth Movement
Malocclusion Class II, Malocclusion, Angle Class I
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.
Mohamed AE Shendy principal investigator
Lecturer - Orthodontic department -faculty of dental medicine -Al-Azhar university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid hyrax distalizer and Pendulum distalizer in people with Angle Class 2 Malocclusion, run by Mohamed Abdelrhman Shendy Abdelrhman at 2 sites 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Angles in degree SNA,SNB,ANB, Molar Rotation (time frame: 6 months). The study lists 2 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 NCT05470179, which also lists 2 linked publications.
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 22 May 2024.