- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07269951
The Bone Thickness of Infrazygomatic Crest Was Measured on CBCTs (IZC)
November 25, 2025 updated by: Fady Hussein, Cairo University
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
95
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cairo, Egypt
- Faculty of Dentistry Cairo University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- Patients having full permanent dentition
- all cases were indicated for CBCT for their orthodontic treatment
- Patients with sound dentition
Exclusion Criteria:
- craniofacial anomalies and facial asymmetries
- Unclear CBCT
- mixed dentition
- Patients with systemic bone disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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measure bone thickness of infrazygomatic crest
Time Frame: from enrollment to the end of taking measurements at 8 weeks
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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
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from enrollment to the end of taking measurements at 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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proper angulation of miniscrew insertion
Time Frame: from enrollment to the end of taking measurements at 8 weeks
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a clinical guide to clinicians was done to guide the clinician the proper angulation of long axis of miniscrew and occlusal plane
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from enrollment to the end of taking measurements at 8 weeks
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check asymmetry of right and left sides per patient
Time Frame: from enrollment to the end of taking measurements at 8 weeks
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the right and left bone thickness was measured to detect any asymmetry between both sides
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from enrollment to the end of taking measurements at 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Lima 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.
- Hijazi 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 24, 2025
Primary Completion (Actual)
September 30, 2025
Study Completion (Actual)
September 30, 2025
Study Registration Dates
First Submitted
August 23, 2025
First Submitted That Met QC Criteria
November 25, 2025
First Posted (Actual)
December 8, 2025
Study Record Updates
Last Update Posted (Actual)
December 8, 2025
Last Update Submitted That Met QC Criteria
November 25, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 31-3-22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
mean age of the patients mean thickness of infrazygomatic crest
IPD Sharing Time Frame
start date for IPD sharing : 1 December, 2025 start date for IPD sharing : 1 December, 2026
IPD Sharing Access Criteria
anyone will be able to access the IPD and supporting information, they will be able to access study protocol, they will be able to access it by sending Email to fady.fahim@gmail.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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