- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06996821
- Original Trial
Evaluation of Impacted or Included Maxillary Canines on Dentofacial Structures, and Airway and Nasal Fossa Dimensions (Sinuses@Canine)
May 26, 2025 updated by: JAVIER MONTERO
The study retrospectively analyzed previously acquired CBCT images to evaluate specific anatomical features, such as [e.g., "maxillary sinus and nasal fossa volumes"].
No active patient participation or new clinical procedures is required; this information is used to measure sinus and fossa dimensions.
Study Overview
Status
Completed
Conditions
Detailed Description
The study analysed the CBCTs of patients, each assigned to one of three groups: control, unilateral canine impaction, or bilateral canine impaction.
Each group was assigned by gender.
Three values were analysed: maxillary sinuses left (MSL) and right (MSR), and sinuses with fossa MSNF measures in mm3.
Study Type
Observational
Enrollment (Actual)
90
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
-
-
-
Madrid, Spain
- Universidad de Salamanca
-
-
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
N/A
Sampling Method
Non-Probability Sample
Study Population
Orthodontic Department of Alfonxo X Sabio Masters' Clinics
Description
Inclusion Criteria:
- unilateral or bilateral canine inclusion,
- young pacients between 10 and 23 years old.
Exclusion Criteria:
- pregnant women,
- major craniofacial deformities (such as cleft palate, severe asymmetric malocclusion, trauma or head & neck oncologic surgery),
- surgeries other than maxillomandibular advancement,
- patients with maxillary compression or syndromes
- any nasal or nasopharyngeal airway obstruction.
- skeletal, dental or dentoalveolar transversal or vertical issues
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Different Volumes of Maxillary Sinuses and Nasal Airway Complex
Time Frame: November 2024 to February 2025
|
Volume (in mm³) of the right maxillary sinus, left maxillary sinus, and combined nasal and maxillary sinus airway complex, measured using cone-beam computed tomography (CBCT) and Dolphin Imaging software.
Measurements are performed in axial, coronal, and sagittal planes using standardized sensitivity and anatomical reference points.
|
November 2024 to February 2025
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
November 1, 2024
Primary Completion (Actual)
February 1, 2025
Study Completion (Actual)
February 1, 2025
Study Registration Dates
First Submitted
May 14, 2025
First Submitted That Met QC Criteria
May 26, 2025
First Posted (Actual)
May 30, 2025
Study Record Updates
Last Update Posted (Actual)
May 30, 2025
Last Update Submitted That Met QC Criteria
May 26, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01/321 (Other Identifier: Universidas Alfonso X El Sabio)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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