Impacted CaninesSinuses@CanineNCT06996821
Evaluation of Impacted or Included Maxillary Canines on Dentofacial Structures, and Airway and Nasal Fossa Dimensions
An observational study of Impacted Canines and Maxillary Sinus, run by JAVIER MONTERO at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 23 years
- Conditions the study is for
- Impacted Canines, Maxillary Sinus
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2024to 1 Feb 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 10 to 23 years
- All sexes
- Child, Adult
Study population: Orthodontic Department of Alfonxo X Sabio Masters' Clinics
Who may be able to join
- unilateral or bilateral canine inclusion,
- young pacients between 10 and 23 years old.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Impacted Canines, Maxillary Sinus
What is being measured
The primary outcome is the main question the study is designed to answer.
Different Volumes of Maxillary Sinuses and Nasal Airway Complex
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.
Measured: November 2024 to February 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Nov 2024
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted CaninesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- JAVIER MONTERO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, JAVIER MONTERO, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996821
- Sponsor's protocol ID
- 01/321
- Other IDs
- 01/321
- Acronym
- Sinuses@Canine
- Status last verified
- Feb 2025
- First submitted
- 14 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Impacted or Included Maxillary Canines on Dentofacial Structures, and Airway and Nasal Fossa Dimensions
- ClinicalTrials.gov ID
- NCT06996821
- Acronym / sponsor ID
- Sinuses@Canine / 01/321
- Conditions
- Impacted Canines, Maxillary Sinus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- JAVIER MONTEROUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 30 May 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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 to 23 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Orthodontic Department of Alfonxo X Sabio Masters' Clinics
Key inclusion criteria (2 listed)
- unilateral or bilateral canine inclusion,
- young pacients between 10 and 23 years old.
Key exclusion criteria (6 listed)
- 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.
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
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.
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 30 May 2025.
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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 Impacted Canines and Maxillary Sinus, run by JAVIER MONTERO at 1 site in Spain.
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 2 inclusion and 6 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 30 May 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 Spain. 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?
Different Volumes of Maxillary Sinuses and Nasal Airway Complex (time frame: November 2024 to February 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2025.