NCT06765148

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 24, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

21 days

First QC Date

December 24, 2024

Last Update Submit

January 2, 2025

Conditions

Keywords

cone beam computed tomographyLithiasismaxillary sinuspanoramic radiography

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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

    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).

    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.

    for three days from the beginning of the study

Interventions

Retrospective radiologic study

Eligibility Criteria

Age11 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retrospective maxillary sinus included CBCT images

You may qualify if:

  • DPR and CBCT and also had a maximum of 3 months
  • Image quality was sufficient
  • No artifacts CBCT images

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdogan University Training and Research Hospital

Rize, 53100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Lithiasis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

December 24, 2024

First Posted

January 9, 2025

Study Start

December 1, 2024

Primary Completion

December 22, 2024

Study Completion

December 23, 2024

Last Updated

January 9, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations