Class II MalocclusionNCT07875660
Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
A study testing Infrazygomatic Crest Miniscrews in people with Class II Malocclusion, run by Mansoura University at 1 site in Egypt.
Trial summary
This prospective clinical study will evaluate the effects of moving the entire upper dental arch backward using infrazygomatic crest miniscrews in participants with Class II malocclusion. Class II malocclusion is a type of bite problem in which the upper and lower teeth do not have a normal front-to-back relationship. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Class II Malocclusion
- What is being tested?
- Infrazygomatic Crest Miniscrews
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2026to 20 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 15 and 30 years.
- Non-extraction treatment plan, except for third molar extraction when indicated.
- Class II molar relationship
- Absence of any syndrome or systemic disease.
- No history of previous orthodontic treatment.
- Good oral hygiene.
Who cannot join
- Patients indicated for extraction treatment.
- Patients showing symptoms of temporomandibular disorders.
- Patients with periodontal diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University
Al Mansurah, Dakahlia Governorate
About this study
Official title: Total Arch Maxillary Distalization Using Infrazygomatic Crest Miniscrews In the Treatment of Class II Malocclusion: A Prospective Study
This prospective clinical study will evaluate the effects of moving the entire upper dental arch backward using infrazygomatic crest miniscrews in participants with Class II malocclusion.
Class II malocclusion is a type of bite problem in which the upper and lower teeth do not have a normal front-to-back relationship. Infrazygomatic crest miniscrews provide temporary skeletal anchorage that can be used to move the upper teeth backward while reducing dependence on patient cooperation.
Read more
Participants will receive orthodontic treatment using bilateral infrazygomatic crest miniscrews connected to the upper orthodontic archwire through power arms and elastomeric chains. Changes produced by treatment will be evaluated using clinical photographs, radiographs, and digital dental models obtained before distalization and after correction of the Class II molar relationship.
The study will assess dental, skeletal, soft-tissue, and maxillary arch changes associated with this treatment approach.
Read the detailed description
Class II malocclusion is commonly treated by distal movement of the maxillary dentition when appropriate. Conventional distalization approaches may depend on patient cooperation and may have limitations related to anchorage control. Temporary skeletal anchorage devices, including orthodontic miniscrews, provide a source of anchorage that can reduce dependence on patient compliance.
The infrazygomatic crest is located superior and lateral to the maxillary molar region. Placement of miniscrews in this extra-alveolar region allows orthodontic tooth movement with less interference between the miniscrews and the roots of the teeth during distalization.
In this prospective clinical study, en-masse distalization of the maxillary dental arch will be performed using bilateral infrazygomatic crest miniscrews. After orthodontic leveling and alignment, 6-mm power arms will be positioned between the maxillary lateral incisors and canines bilaterally. Elastomeric chains will connect the power arms to the infrazygomatic crest miniscrews to produce distalizing forces.
Study records will be obtained at two time points: before treatment (T1) and after correction of the Class II molar relationship (T2). Records will include extraoral and intraoral photographs, lateral cephalometric and panoramic radiographs, and digital dental models.
Cephalometric evaluation will be used to assess skeletal, dental, and soft-tissue changes. Digital dental models will be used to assess changes in maxillary arch dimensions, including arch length, arch perimeter, and transverse dental arch widths. Pre-treatment and post-distalization measurements will be compared to evaluate the effects of total maxillary arch distalization using infrazygomatic crest miniscrews.
- Conditions
- Class II Malocclusion
- Being tested
- Infrazygomatic Crest Miniscrews
- Keywords
- Class II Malocclusion, Maxillary Arch Distalization, Infrazygomatic Crest Miniscrews, Orthodontic Miniscrews, Temporary Anchorage Devices, Skeletal Anchorage, En-Masse Distalization
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrazygomatic Crest MiniscrewsDevice
Two bilateral infrazygomatic crest miniscrews (Ortho Central, Korea), 2 mm in diameter and 12 mm in length, will be used as skeletal anchorage for en-masse maxillary arch distalization. The miniscrews will be inserted in the infrazygomatic crest region, commonly between the maxillary first and second molars, approximately 11 mm above the occlusal plane. Six-millimeter power arms will be placed bilaterally between the maxillary lateral incisor and canine. Closed elastomeric power chains will connect the miniscrews to the archwire hooks, applying approximately 350 g of distalizing force.
| Study group | Role | What they receive |
|---|---|---|
| Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews | Experimental | Participants with Class II malocclusion will undergo en-masse maxillary arch distalization using bilateral infrazygomatic crest miniscrews. Two miniscrews measuring 2 mm in diameter and 12 mm in length will be used. Six-millimeter power arms will be placed bilaterally between the maxillary lateral incisor and canine. Closed elastomeric power chains will connect the miniscrews to the archwire hooks, applying approximately 350 g of distalizing force. Receives: Device: Infrazygomatic Crest Miniscrews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sagittal Position of the Maxillary First Molar (U6 Crown to Y-Axis)
The sagittal position of the maxillary first molar will be assessed on lateral cephalometric radiographs by measuring the linear distance, in millimeters, from the mesiobuccal crown of the maxillary first molar (U6) to the Y-axis. The Y-axis is defined as a vertical reference line perpendicular to the X-axis and passing through Sella. Change between T1 and T2 will be used to quantify maxillary first molar distalization.
Measured: Baseline (T1) and six months after treatment initiation (T2), following correction of the Class II molar relationship.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start15 Sep 2026
- Primary completion15 Jun 2027 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective single-group interventional clinical study in which all participants with Class II malocclusion will receive maxillary arch distalization using bilateral infrazygomatic crest miniscrews. Clinical and radiographic records will be obtained at T1 (pre-treatment) and T2 (after correction of the Class II molar relationship) to evaluate treatment-related changes.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed M Fouda, Principal investigator, Faculty of Dentistry, Mansoura UniversityGhadir A Ragheb, Principal investigator, Faculty of Dentistry, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875660
- Sponsor's protocol ID
- MS.26.09.289
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The study protocol does not include a plan for sharing participant-level data, and data will be kept confidential in accordance with institutional and ethical requirements.
Publications
Watanabe H, Deguchi T, Hasegawa M, Ito M, Kim S, Takano-Yamamoto T. Orthodontic miniscrew failure rate and root proximity, insertion angle, bone contact length, and bone density. Orthod Craniofac Res. 2013 Feb;16(1):44-55. doi: 10.1111/ocr.12003. Epub 2012 Sep 3.
PubMed 23311659Jing Z, Wu Y, Jiang W, Zhao L, Jing D, Zhang N, Cao X, Xu Z, Zhao Z. Factors Affecting the Clinical Success Rate of Miniscrew Implants for Orthodontic Treatment. Int J Oral Maxillofac Implants. 2016 Jul-Aug;31(4):835-41. doi: 10.11607/jomi.4197.
PubMed 27447150Alharbi F, Almuzian M, Bearn D. Miniscrews failure rate in orthodontics: systematic review and meta-analysis. Eur J Orthod. 2018 Sep 28;40(5):519-530. doi: 10.1093/ejo/cjx093.
PubMed 29315365Su L, Song H, Huang X. Accuracy of two orthodontic mini-implant templates in the infrazygomatic crest zone: a prospective cohort study. BMC Oral Health. 2022 Jun 24;22(1):252. doi: 10.1186/s12903-022-02285-0.
PubMed 35739518Ali ZM, Shamaa MS, Mohammad MH. Comparison of direct and indirect skeletal anchorage for maxillary molar distalization in Class II malocclusion: A prospective clinical study. J World Fed Orthod. 2025 Oct;14(5):251-258. doi: 10.1016/j.ejwf.2025.05.002. Epub 2025 Jun 17.
PubMed 40533287Matias M, Flores-Mir C, Almeida MR, Vieira BDS, Freitas KMS, Nunes DC, Ferreira MC, Ursi W. Miniscrew insertion sites of infrazygomatic crest and mandibular buccal shelf in different vertical craniofacial patterns: A cone-beam computed tomography study. Korean J Orthod. 2021 Nov 25;51(6):387-396. doi: 10.4041/kjod.2021.51.6.387.
PubMed 34803027Gill G, Shashidhar K, Kuttappa MN, Kushalappa P B D, Sivamurthy G, Mallick S. Failure rates and factors associated with infrazygomatic crestal orthodontic implants - A prospective study. J Oral Biol Craniofac Res. 2023 Mar-Apr;13(2):283-289. doi: 10.1016/j.jobcr.2023.02.010. Epub 2023 Feb 25.
PubMed 36880016He Y, Liu J, Huang R, Chen X, Jia X, Zeng N, Fan X, Huang X. Clinical analysis of successful insertion of orthodontic mini-implants in infrazygomatic crest. BMC Oral Health. 2023 Jun 1;23(1):348. doi: 10.1186/s12903-023-03081-0.
PubMed 37264370Shaikh A, Jamdar AF, Galgali SA, Patil S, Patel I, Hemagiriyappa MS. Efficacy of Infrazygomatic Crest Implants for Full-arch Distalization of Maxilla and Reduction of Gummy Smile in Class II Malocclusion. J Contemp Dent Pract. 2021 Oct 1;22(10):1135-1143.
PubMed 35197381Rosa WGN, de Almeida-Pedrin RR, Oltramari PVP, de Castro Conti ACF, Poleti TMFF, Shroff B, de Almeida MR. Total arch maxillary distalization using infrazygomatic crest miniscrews in the treatment of Class II malocclusion: a prospective study. Angle Orthod. 2023 Jan 1;93(1):41-48. doi: 10.2319/050122-326.1.
PubMed 36126679
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Arch Maxillary Distalization Using Infrazygomatic Crest Miniscrews In the Treatment of Class II Malocclusion: A Prospective Study
- ClinicalTrials.gov ID
- NCT07875660
- Acronym / sponsor ID
- MS.26.09.289
- Conditions
- Class II Malocclusion
- Keywords
- Class II Malocclusion, Maxillary Arch Distalization, Infrazygomatic Crest Miniscrews, Orthodontic Miniscrews, Temporary Anchorage Devices, Skeletal Anchorage, En-Masse Distalization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 15 Oct 2026 (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 prospective clinical study will evaluate the effects of moving the entire upper dental arch backward using infrazygomatic crest miniscrews in participants with Class II malocclusion.
Class II malocclusion is a type of bite problem in which the upper and lower teeth do not have a normal front-to-back relationship. Infrazygomatic crest miniscrews provide temporary skeletal anchorage that can be used to move the upper teeth backward while reducing dependence on patient cooperation.
Participants will receive orthodontic treatment using bilateral infrazygomatic crest miniscrews connected to the upper orthodontic archwire through power arms and elastomeric chains. Changes produced by treatment will be evaluated using clinical photographs, radiographs, and digital dental models obtained before distalization and after correction of the Class II molar relationship.
The study will assess dental, skeletal, soft-tissue, and maxillary arch changes associated with this treatment approach.
Detailed description
Class II malocclusion is commonly treated by distal movement of the maxillary dentition when appropriate. Conventional distalization approaches may depend on patient cooperation and may have limitations related to anchorage control. Temporary skeletal anchorage devices, including orthodontic miniscrews, provide a source of anchorage that can reduce dependence on patient compliance.
The infrazygomatic crest is located superior and lateral to the maxillary molar region. Placement of miniscrews in this extra-alveolar region allows orthodontic tooth movement with less interference between the miniscrews and the roots of the teeth during distalization.
In this prospective clinical study, en-masse distalization of the maxillary dental arch will be performed using bilateral infrazygomatic crest miniscrews. After orthodontic leveling and alignment, 6-mm power arms will be positioned between the maxillary lateral incisors and canines bilaterally. Elastomeric chains will connect the power arms to the infrazygomatic crest miniscrews to produce distalizing forces.
Study records will be obtained at two time points: before treatment (T1) and after correction of the Class II molar relationship (T2). Records will include extraoral and intraoral photographs, lateral cephalometric and panoramic radiographs, and digital dental models.
Cephalometric evaluation will be used to assess skeletal, dental, and soft-tissue changes. Digital dental models will be used to assess changes in maxillary arch dimensions, including arch length, arch perimeter, and transverse dental arch widths. Pre-treatment and post-distalization measurements will be compared to evaluate the effects of total maxillary arch distalization using infrazygomatic crest miniscrews.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective single-group interventional clinical study in which all participants with Class II malocclusion will receive maxillary arch distalization using bilateral infrazygomatic crest miniscrews. Clinical and radiographic records will be obtained at T1 (pre-treatment) and T2 (after correction of the Class II molar relationship) to evaluate treatment-related changes.
| Arm | Type | Receives |
|---|---|---|
| Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews | Experimental | Device: Infrazygomatic Crest MiniscrewsParticipants with Class II malocclusion will undergo en-masse maxillary arch distalization using bilateral infrazygomatic crest miniscrews. Two miniscrews measuring 2 mm in diameter and 12 mm in length will be used. Six-millimeter power arms will be placed bilaterally between the maxillary lateral incisor and canine. Closed elastomeric power chains will connect the miniscrews to the archwire hooks, applying approximately 350 g of distalizing force. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age between 15 and 30 years.
- Non-extraction treatment plan, except for third molar extraction when indicated.
- Class II molar relationship
- Absence of any syndrome or systemic disease.
- No history of previous orthodontic treatment.
Key exclusion criteria (3 listed)
- Patients indicated for extraction treatment.
- Patients showing symptoms of temporomandibular disorders.
- Patients with periodontal diseases.
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 |
|---|---|---|
| Infrazygomatic Crest MiniscrewsTwo bilateral infrazygomatic crest miniscrews (Ortho Central, Korea), 2 mm in diameter and 12 mm in length, will be used as skeletal anchorage for en-masse maxillary arch distalization. The miniscrews will be inserted in the infrazygomatic crest region, commonly between the maxillary first and second molars, approximately 11 mm above the occlusal plane. Six-millimeter power arms will be placed bilaterally between the maxillary lateral incisor and canine. Closed elastomeric power chains will connect the miniscrews to the archwire hooks, applying approximately 350 g of distalizing force. | Device | Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews |
Primary outcome
Change in Sagittal Position of the Maxillary First Molar (U6 Crown to Y-Axis)
Time frame: Baseline (T1) and six months after treatment initiation (T2), following correction of the Class II molar relationship.
The sagittal position of the maxillary first molar will be assessed on lateral cephalometric radiographs by measuring the linear distance, in millimeters, from the mesiobuccal crown of the maxillary first molar (U6) to the Y-axis. The Y-axis is defined as a vertical reference line perpendicular to the X-axis and passing through Sella. Change between T1 and T2 will be used to quantify maxillary first molar distalization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 23311659Watanabe H, Deguchi T, Hasegawa M, Ito M, Kim S, Takano-Yamamoto T. Orthodontic miniscrew failure rate and root proximity, insertion angle, bone contact length, and bone density. Orthod Craniofac Res. 2013 Feb;16(1):44-55. doi: 10.1111/ocr.12003. Epub 2012 Sep 3.
- Background: PubMed 27447150Jing Z, Wu Y, Jiang W, Zhao L, Jing D, Zhang N, Cao X, Xu Z, Zhao Z. Factors Affecting the Clinical Success Rate of Miniscrew Implants for Orthodontic Treatment. Int J Oral Maxillofac Implants. 2016 Jul-Aug;31(4):835-41. doi: 10.11607/jomi.4197.
- Background: PubMed 29315365Alharbi F, Almuzian M, Bearn D. Miniscrews failure rate in orthodontics: systematic review and meta-analysis. Eur J Orthod. 2018 Sep 28;40(5):519-530. doi: 10.1093/ejo/cjx093.
- Background: PubMed 35739518Su L, Song H, Huang X. Accuracy of two orthodontic mini-implant templates in the infrazygomatic crest zone: a prospective cohort study. BMC Oral Health. 2022 Jun 24;22(1):252. doi: 10.1186/s12903-022-02285-0.
- Background: PubMed 40533287Ali ZM, Shamaa MS, Mohammad MH. Comparison of direct and indirect skeletal anchorage for maxillary molar distalization in Class II malocclusion: A prospective clinical study. J World Fed Orthod. 2025 Oct;14(5):251-258. doi: 10.1016/j.ejwf.2025.05.002. Epub 2025 Jun 17.
- Background: PubMed 34803027Matias M, Flores-Mir C, Almeida MR, Vieira BDS, Freitas KMS, Nunes DC, Ferreira MC, Ursi W. Miniscrew insertion sites of infrazygomatic crest and mandibular buccal shelf in different vertical craniofacial patterns: A cone-beam computed tomography study. Korean J Orthod. 2021 Nov 25;51(6):387-396. doi: 10.4041/kjod.2021.51.6.387.
- Background: PubMed 36880016Gill G, Shashidhar K, Kuttappa MN, Kushalappa P B D, Sivamurthy G, Mallick S. Failure rates and factors associated with infrazygomatic crestal orthodontic implants - A prospective study. J Oral Biol Craniofac Res. 2023 Mar-Apr;13(2):283-289. doi: 10.1016/j.jobcr.2023.02.010. Epub 2023 Feb 25.
- Background: PubMed 37264370He Y, Liu J, Huang R, Chen X, Jia X, Zeng N, Fan X, Huang X. Clinical analysis of successful insertion of orthodontic mini-implants in infrazygomatic crest. BMC Oral Health. 2023 Jun 1;23(1):348. doi: 10.1186/s12903-023-03081-0.
- Background: PubMed 35197381Shaikh A, Jamdar AF, Galgali SA, Patil S, Patel I, Hemagiriyappa MS. Efficacy of Infrazygomatic Crest Implants for Full-arch Distalization of Maxilla and Reduction of Gummy Smile in Class II Malocclusion. J Contemp Dent Pract. 2021 Oct 1;22(10):1135-1143.
- Background: PubMed 36126679Rosa WGN, de Almeida-Pedrin RR, Oltramari PVP, de Castro Conti ACF, Poleti TMFF, Shroff B, de Almeida MR. Total arch maxillary distalization using infrazygomatic crest miniscrews in the treatment of Class II malocclusion: a prospective study. Angle Orthod. 2023 Jan 1;93(1):41-48. doi: 10.2319/050122-326.1.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The study protocol does not include a plan for sharing participant-level data, and data will be kept confidential in accordance with institutional and ethical requirements.
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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.
Ahmed M Fouda principal investigator
Faculty of Dentistry, Mansoura University
Ghadir A Ragheb principal investigator
Faculty of Dentistry, Mansoura 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 Infrazygomatic Crest Miniscrews in people with Class II Malocclusion, run by Mansoura 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: looking for participants now, as of the sponsor's last update on 20 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hayder A Abdulrazaq, B.D.S. (+201550059646, hayderalmashkor@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sagittal Position of the Maxillary First Molar (U6 Crown to Y-Axis) (time frame: Baseline (T1) and six months after treatment initiation (T2), following correction of the Class II molar relationship.). 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 NCT07875660, which also lists 10 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 20 Oct 2026.