Miniscrew PlacementIZCNCT07269951
The Bone Thickness of Infrazygomatic Crest Was Measured on CBCTs
An observational study of Miniscrew Placement, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be done on 95 patients with CBCTs retrospectively, to evaluate the bone depth of infrazygomatic crest region for selecting suitable size of miniscrews and proper insertion angle clinical guide in the infrazygomatic crest without injuring the mesiobuccal root of the maxillary first molar. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Miniscrew Placement
- How many people
- 95 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Sep 2025to 30 Sep 2025
- Phase
- Observational
- 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 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study will be done on 100 CBCTs of 95 patients; 58 females and 37 males retrospectively to evaluate the bone depth of infrazygomatic crest region for selecting suitable size of miniscrews and proper insertion angle clinical guide in the infrazygomatic crest without injuring the mesiobuccal root of the maxillary first molar.
Who may be able to join
- Patients having full permanent dentition
- all cases were indicated for CBCT for their orthodontic treatment
- Patients with sound dentition
Who cannot join
- craniofacial anomalies and facial asymmetries
- Unclear CBCT
- mixed dentition
- Patients with systemic bone disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Bone Thickness in the Infrazygomatic Crest and Proper Insertion Angle for Miniscrew Positioning: A Retrospective CBCT Study
This study will be done on 95 patients with CBCTs retrospectively, to evaluate the bone depth of infrazygomatic crest region for selecting suitable size of miniscrews and proper insertion angle clinical guide in the infrazygomatic crest without injuring the mesiobuccal root of the maxillary first molar.
Read the detailed description
CBCTs of 95 patients were collected retrospectively from archives of Faculty of Dentistry, Cairo University, that were requested for different dental purposes. The thickness of the IZC was measured above mesio-buccal root of upper 6 (U6MB), above disto-buccal root of upper 6 (U6DB) and contact point between upper 6 and 7 roots (U6-7). The distance from point of entry of miniscrew to the occlusal plane, that saves roots from injury, was measured. Then, the angle of miniscrew insertion in relation to the occlusal plane was measured at maximum thickness available together with point of entry in relation to the occlusal plane. The IZC thickness of right and left sides of each patient was compared, also compared in males and females. Kruskal-Wallis test, Paired Wilcoxon signed rank test \& Spearman correlation were used to analyze results
- Conditions
- Miniscrew Placement
- Keywords
- miniscrew, TAD, infrazygomatic crest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 95 patients were randomly chosen constituting both males and females | Following the inclusion and exclusion criteria, 95 patients were randomly chosen constituting both males and females with an age range of 20-35 years old (58 females and 37 males). CBCTs were acquired in the same manner, using an i-CAT scanner with 110 kVp, 60 mA, 0.3-mm voxel size, a scan time of 18 seconds, and a field of view of 17x 23 cm. CBCT measurements were analyzed using Invivo 6 (Anatomage, Inc., Santa Clara, Calif). These tomographic images were reoriented so that the natural head position coincided with the true horizontal plane in an attempt to reduce possible errors in head positioning during image acquisition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure bone thickness of infrazygomatic crest
the bone thickness will be measured on CBCT from coronal slice at 3 points : above mesio-buccal root of upper first molar, above disto-buccal root of upper first molar and between upper first and second molars contact points
Measured: from enrollment to the end of taking measurements at 8 weeks
Secondary outcomes (2)
proper angulation of miniscrew insertion
a clinical guide to clinicians was done to guide the clinician the proper angulation of long axis of miniscrew and occlusal plane
Measured: from enrollment to the end of taking measurements at 8 weeks
check asymmetry of right and left sides per patient
the right and left bone thickness was measured to detect any asymmetry between both sides
Measured: from enrollment to the end of taking measurements at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start24 Sep 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Miniscrew PlacementStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fady Hussein, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269951
- Sponsor's protocol ID
- 31-3-22
- Acronym
- IZC
- Status last verified
- Nov 2025
- First submitted
- 23 Aug 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: mean age of the patients mean thickness of infrazygomatic crest
Publications
Husseini B, Younes R, Baumgaertel S, El Wak T, El Osta N, Bassil-Nassif N, Bouserhal J. Assessment of infrazygomatic crest dimensions in different vertical facial growth types for miniscrew insertion: A cone-beam computed tomography study. Am J Orthod Dentofacial Orthop. 2022 Dec;162(6):917-926. doi: 10.1016/j.ajodo.2021.07.029. Epub 2022 Sep 13.
PubMed 36109268Lima A Jr, Domingos RG, Cunha Ribeiro AN, Rino Neto J, de Paiva JB. Safe sites for orthodontic miniscrew insertion in the infrazygomatic crest area in different facial types: A tomographic study. Am J Orthod Dentofacial Orthop. 2022 Jan;161(1):37-45. doi: 10.1016/j.ajodo.2020.06.044. Epub 2021 Aug 12.
PubMed 34391619Hijazi Muwaquet K, Muwaquet Rodriguez S, Ferrer Molina M, Hijazi Alsadi T. Optimizing Infrazygomatic Miniscrew Insertion Parameters: Systematic Review and Meta-Regression Analysis of Bone Thickness by Insertion Height, Angulation, and Anatomical Position. J Clin Med. 2025 Jun 5;14(11):4005. doi: 10.3390/jcm14114005.
PubMed 40507767
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bone Thickness in the Infrazygomatic Crest and Proper Insertion Angle for Miniscrew Positioning: A Retrospective CBCT Study
- ClinicalTrials.gov ID
- NCT07269951
- Acronym / sponsor ID
- IZC / 31-3-22
- Conditions
- Miniscrew Placement
- Keywords
- miniscrew, TAD, infrazygomatic crest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 8 Dec 2025 (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 will be done on 95 patients with CBCTs retrospectively, to evaluate the bone depth of infrazygomatic crest region for selecting suitable size of miniscrews and proper insertion angle clinical guide in the infrazygomatic crest without injuring the mesiobuccal root of the maxillary first molar.
Detailed description
CBCTs of 95 patients were collected retrospectively from archives of Faculty of Dentistry, Cairo University, that were requested for different dental purposes. The thickness of the IZC was measured above mesio-buccal root of upper 6 (U6MB), above disto-buccal root of upper 6 (U6DB) and contact point between upper 6 and 7 roots (U6-7). The distance from point of entry of miniscrew to the occlusal plane, that saves roots from injury, was measured. Then, the angle of miniscrew insertion in relation to the occlusal plane was measured at maximum thickness available together with point of entry in relation to the occlusal plane. The IZC thickness of right and left sides of each patient was compared, also compared in males and females. Kruskal-Wallis test, Paired Wilcoxon signed rank test \& Spearman correlation were used to analyze results
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 95 patients were randomly chosen constituting both males and females | – | –Following the inclusion and exclusion criteria, 95 patients were randomly chosen constituting both males and females with an age range of 20-35 years old (58 females and 37 males). CBCTs were acquired in the same manner, using an i-CAT scanner with 110 kVp, 60 mA, 0.3-mm voxel size, a scan time of 18 seconds, and a field of view of 17x 23 cm. CBCT measurements were analyzed using Invivo 6 (Anatomage, Inc., Santa Clara, Calif). These tomographic images were reoriented so that the natural head position coincided with the true horizontal plane in an attempt to reduce possible errors in head positioning during image acquisition. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study will be done on 100 CBCTs of 95 patients; 58 females and 37 males retrospectively to evaluate the bone depth of infrazygomatic crest region for selecting suitable size of miniscrews and proper insertion angle clinical guide in the infrazygomatic crest without injuring the mesiobuccal root of the maxillary first molar.
Key inclusion criteria (3 listed)
- Patients having full permanent dentition
- all cases were indicated for CBCT for their orthodontic treatment
- Patients with sound dentition
Key exclusion criteria (4 listed)
- craniofacial anomalies and facial asymmetries
- Unclear CBCT
- mixed dentition
- Patients with systemic bone disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
measure bone thickness of infrazygomatic crest
Time frame: from enrollment to the end of taking measurements at 8 weeks
the bone thickness will be measured on CBCT from coronal slice at 3 points : above mesio-buccal root of upper first molar, above disto-buccal root of upper first molar and between upper first and second molars contact points
2 secondary outcomes
proper angulation of miniscrew insertion
Time frame: from enrollment to the end of taking measurements at 8 weeks
check asymmetry of right and left sides per patient
Time frame: from enrollment to the end of taking measurements at 8 weeks
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 8 Dec 2025.
- Results publication: PubMed 36109268Husseini B, Younes R, Baumgaertel S, El Wak T, El Osta N, Bassil-Nassif N, Bouserhal J. Assessment of infrazygomatic crest dimensions in different vertical facial growth types for miniscrew insertion: A cone-beam computed tomography study. Am J Orthod Dentofacial Orthop. 2022 Dec;162(6):917-926. doi: 10.1016/j.ajodo.2021.07.029. Epub 2022 Sep 13.
- Results publication: PubMed 34391619Lima A Jr, Domingos RG, Cunha Ribeiro AN, Rino Neto J, de Paiva JB. Safe sites for orthodontic miniscrew insertion in the infrazygomatic crest area in different facial types: A tomographic study. Am J Orthod Dentofacial Orthop. 2022 Jan;161(1):37-45. doi: 10.1016/j.ajodo.2020.06.044. Epub 2021 Aug 12.
- Results publication: PubMed 40507767Hijazi Muwaquet K, Muwaquet Rodriguez S, Ferrer Molina M, Hijazi Alsadi T. Optimizing Infrazygomatic Miniscrew Insertion Parameters: Systematic Review and Meta-Regression Analysis of Bone Thickness by Insertion Height, Angulation, and Anatomical Position. J Clin Med. 2025 Jun 5;14(11):4005. doi: 10.3390/jcm14114005.
- Individual participant dataSharing planned: Yes. mean age of the patients mean thickness of infrazygomatic crest
Related trials for Miniscrew Placement
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Evaluation of Two Mini-implant Diameters in the Infra-zygomatic Crest Region.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Miniscrew Placement, run by Cairo 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 3 inclusion and 4 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 8 Dec 2025. 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?
measure bone thickness of infrazygomatic crest (time frame: from enrollment to the end of taking measurements at 8 weeks). 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 NCT07269951, which also lists 3 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 8 Dec 2025.