AntrolithNCT06765148
Radiodiagnostic Properties of Maxillary Antroliths
An observational study of Antrolith and Maxillary Sinus, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Background: To evaluate the frequency and radiodiagnostic characteristics of maxillary antroliths using cone beam computed tomography. Materials and Methods: A review of 1166 patients aged 11-85 years was conducted to assess the frequency of maxillary antroliths, considering sex, age, and location. Read more about this study
- Who is it for?
- Ages 11 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Antrolith, Maxillary Sinus
- What is being tested?
- Retrospective radiologic study
- How many people
- 1,200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 23 Dec 2024
- 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 11 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Retrospective maxillary sinus included CBCT images
Who may be able to join
- DPR and CBCT and also had a maximum of 3 months
- Image quality was sufficient
- No artifacts CBCT images
Who cannot join
- Tomographic images that contained pathologies such as cysts/tumors in the
- Insufficient diagnostic quality
- History of maxillofacial trauma or surgery, any syndrome/bone-related disease/metabolic disease
- Insufficient diagnostic quality or patient position-related artifacts
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdogan University Training and Research Hospital
Rize, 53100
About this study
Official title: Radiodiagnostic Properties of Maxillary Antroliths: a Retrospective Cone Beam Computed Tomography Study
Background: To evaluate the frequency and radiodiagnostic characteristics of maxillary antroliths using cone beam computed tomography.
Materials and Methods: A review of 1166 patients aged 11-85 years was conducted to assess the frequency of maxillary antroliths, considering sex, age, and location. The relationship between antroliths and sex, location, dental treatment status, and sinus inflammation was evaluated. The shape, size, and volume of the antroliths were also analyzed. Significance was set at p=0.05 for statistical analysis.
- Conditions
- Antrolith, Maxillary Sinus
- Being tested
- Retrospective radiologic study
- Keywords
- cone beam computed tomography, Lithiasis, maxillary sinus, panoramic radiography
- Medical subject headings
- Lithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective radiologic studyOther
Retrospective radiologic study
What is being measured
The primary outcome is the main question the study is designed to answer.
Antrolith descriptive analysis
CBCT images were examined in axial, sagittal, and coronal slices to investigate the presence of antroliths. The age and sex information of the detected cases were recorded.
Measured: for three days from the beginning of the study
Antrolith localization and relationship the dental status evaluation
Each sinus cavity exhibiting antroliths was evaluated for distribution and location as follows: (1) unilateral or bilateral, (2) single or multiple, (3) tooth extraction/root canal treatment/residual root fragment/implant/periodontal disease and/or periapical lesion (any dental cause of sinus inflammation), (4) premolar or molar region, and (5) sinus floor, lateral wall, or medial wall.
Measured: for three days from the beginning of the study
Antrolith and mucosal thickness classification
the detected antroliths were categorized according to the classification of Cho et al. In this classification made according to the sizes of antroliths, Punctate = ≤3 mm in both height and width, Linear = ≤3 mm and more than treble in width, and Amorphous = >3 mm in both width and height.
Additionally, the locations of the openings of the maxillary sinus ostiums were evaluated, and mucosal thickening, if any, was measured. Mucosal thickness measurements were made on coronal slices using NewTom's NNT viewer measuring tool. Similar to Chen et al., the sinus membrane thickness was measured perpendicular to the bone wall, from the maximum thickest region. Similar to Chen et al.'s classification of sinus membrane thickness measurements, which used Block and Dostoury's classification, the mucosal thickness was classified into three subgroups: membrane thicknesses <2 mm, 2-5 mm, and >5 mm. Also, similar to the article by Cho et al., the degree of inflammation in the maxillary sinus was
Measured: for three days from the beginning of the study
Antrolith volume measurement
3D reconstruction and volume measurements of antroliths were performed using the ITK SNAP software (free software under the GNU General Public License developed by the National Institutes of Health, the US National Institute of Biomedical Imaging and Bioenergy needs, the US National Library of Medicine, the Universities of Pennsylvania and North Carolina, and an independent group of developers).
Measured: for three days from the beginning of the study
Different images evaluation for antrolit
In addition, the visibility of antroliths detected on CBCT was also evaluated using panoramic radiographs taken from the patient (Fig 2). The detectability of antroliths in DPRs was evaluated by observers as detectable, suspicious, and undetectable.
Measured: for three days from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Dec 2024
- Primary completion22 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AntrolithStudies 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 crossover
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİLARA NİL GÜNAÇAR, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765148
- Sponsor's protocol ID
- 2024/299
- Status last verified
- Jan 2025
- First submitted
- 24 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gunacar DN, Kose TE, Ceren F. Radiodiagnostic properties of maxillary antroliths: a retrospective cone beam computed tomography study. BMC Oral Health. 2025 Feb 19;25(1):259. doi: 10.1186/s12903-025-05641-y.
PubMed 39972501
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiodiagnostic Properties of Maxillary Antroliths: a Retrospective Cone Beam Computed Tomography Study
- ClinicalTrials.gov ID
- NCT06765148
- Acronym / sponsor ID
- 2024/299
- Conditions
- Antrolith, Maxillary Sinus
- Keywords
- cone beam computed tomography, Lithiasis, maxillary sinus, panoramic radiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 22 Dec 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 9 Jan 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.
Background: To evaluate the frequency and radiodiagnostic characteristics of maxillary antroliths using cone beam computed tomography.
Materials and Methods: A review of 1166 patients aged 11-85 years was conducted to assess the frequency of maxillary antroliths, considering sex, age, and location. The relationship between antroliths and sex, location, dental treatment status, and sinus inflammation was evaluated. The shape, size, and volume of the antroliths were also analyzed. Significance was set at p=0.05 for statistical analysis.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 11 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Retrospective maxillary sinus included CBCT images
Key inclusion criteria (3 listed)
- DPR and CBCT and also had a maximum of 3 months
- Image quality was sufficient
- No artifacts CBCT images
Key exclusion criteria (4 listed)
- Tomographic images that contained pathologies such as cysts/tumors in the
- Insufficient diagnostic quality
- History of maxillofacial trauma or surgery, any syndrome/bone-related disease/metabolic disease
- Insufficient diagnostic quality or patient position-related artifacts
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 |
|---|---|---|
| Retrospective radiologic studyRetrospective radiologic study | Other | – |
Primary outcome
Antrolith descriptive analysis
Time frame: for three days from the beginning of the study
CBCT images were examined in axial, sagittal, and coronal slices to investigate the presence of antroliths. The age and sex information of the detected cases were recorded.
Antrolith localization and relationship the dental status evaluation
Time frame: for three days from the beginning of the study
Each sinus cavity exhibiting antroliths was evaluated for distribution and location as follows: (1) unilateral or bilateral, (2) single or multiple, (3) tooth extraction/root canal treatment/residual root fragment/implant/periodontal disease and/or periapical lesion (any dental cause of sinus inflammation), (4) premolar or molar region, and (5) sinus floor, lateral wall, or medial wall.
Antrolith and mucosal thickness classification
Time frame: for three days from the beginning of the study
the detected antroliths were categorized according to the classification of Cho et al. In this classification made according to the sizes of antroliths, Punctate = ≤3 mm in both height and width, Linear = ≤3 mm and more than treble in width, and Amorphous = >3 mm in both width and height. Additionally, the locations of the openings of the maxillary sinus ostiums were evaluated, and mucosal thickening, if any, was measured. Mucosal thickness measurements were made on coronal slices using NewTom's NNT viewer measuring tool. Similar to Chen et al., the sinus membrane thickness was measured perpendicular to the bone wall, from the maximum thickest region. Similar to Chen et al.'s classification of sinus membrane thickness measurements, which used Block and Dostoury's classification, the mucosal thickness was classified into three subgroups: membrane thicknesses <2 mm, 2-5 mm, and >5 mm. Also, similar to the article by Cho et al., the degree of inflammation in the maxillary sinus was
Antrolith volume measurement
Time frame: for three days from the beginning of the study
3D reconstruction and volume measurements of antroliths were performed using the ITK SNAP software (free software under the GNU General Public License developed by the National Institutes of Health, the US National Institute of Biomedical Imaging and Bioenergy needs, the US National Library of Medicine, the Universities of Pennsylvania and North Carolina, and an independent group of developers).
Different images evaluation for antrolit
Time frame: for three days from the beginning of the study
In addition, the visibility of antroliths detected on CBCT was also evaluated using panoramic radiographs taken from the patient (Fig 2). The detectability of antroliths in DPRs was evaluated by observers as detectable, suspicious, and undetectable.
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 9 Jan 2025.
- Derived from this study: PubMed 39972501Gunacar DN, Kose TE, Ceren F. Radiodiagnostic properties of maxillary antroliths: a retrospective cone beam computed tomography study. BMC Oral Health. 2025 Feb 19;25(1):259. doi: 10.1186/s12903-025-05641-y.
- Individual participant dataSharing planned: No
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 Antrolith and Maxillary Sinus, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
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 9 Jan 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 Turkey (Türkiye). 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?
Antrolith descriptive analysis (time frame: for three days from the beginning of the study). The study lists 5 primary outcomes in all. 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 NCT06765148, which also lists 1 linked publication.
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 9 Jan 2025.