Zero Echo Time MR for the Assessment of Maxillary Sinus and Dental Regions

The aim of this study is to evaluate the efficacy of zero echo time magnetic resonance imaging (ZTE MRI) as an ionizing radiation-free diagnostic method to evaluate both hard and soft tissues and maxillary sinus region before dental implants in the posterior maxillary region.

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Key information

Conditions

Edentulous Alveolar Ridge

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Periodontology, Faculty of Dentistry, Hacettepe University,, Ankara, Turkey (Türkiye)

About this study

Today, cone beam computed tomography (CBCT) is routinely used to evaluate the bone structure of the surgical area, to define the anatomical landmarks in the area, to detect variations, if any, and to evaluate the presence of pathologies before dental implant treatment. However, soft tissue evaluations, which are an important factor in treatment planning and the success of the treatment, cannot be performed adequately on CBCT images, and in addition, there is a significant increase in the exposure of patients to ionizing radiation. Using zero echo time magnetic resonance imaging (ZTE MRI) as a diagnostic tool that does not involve ionizing radiation in dentistry may provide a solution to this situation.

The aim of the present project is to evaluate the efficacy of ZTE MRI as an ionizing radiation-free diagnostic method to evaluate both hard and soft tissues and the maxillary sinus region before dental implants in the posterior maxillary region. For this purpose, it is planned to examine CBCT and ZTE MRI images of patients planned for dental implant treatment, to perform digital measurements with an intraoral scanner and intraoral direct measurements during surgery and to compare the results of bone and soft tissue measurements obtained.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Missing teeth in the maxillary premolar and molar regions
Cone-beam computed tomography images of the tooth-deficient area
Do not have any systemic disease that may affect periodontal tissues (diabetes, rheumatoid arthritis, etc.)
Over the age of 18
Individuals who approved the informed consent form

Exclusion criteria

All maxillary teeth missing
With active periodontitis
Under 18 years of age
Individuals who did not approve the informed consent form.

Treatment and study plan

Primary outcomes

Evaluation of maxillary sinus area with ZET-MR

Time frame: Baseline-18 months
These maxillary sinus evaluations will be conducted on both ZTE MR and CBCT images:
- Thickness of the sinus membrane in millimeters.
- Shape of thickening (dome shape or flat).
- Presence and characteristics of septa in the maxillary sinus. To evaluate the direction of the septum, the angle with the vertical axis will be measured; then the direction of the septum will be classified as vertical (<30°), oblique (between 30° and 60°), and horizontal (between 60° and 90°). In terms of morphology, if the septum extends from one sinus wall to the opposite sinus wall, it will be classified as 'complete'; if it does not reach the opposite wall, it will be considered 'partial'.
- Presence and variations of the posterior superior alveolar artery (intraosseous or below the membrane or on the outer cortex of the lateral sinus wall)
- Diameter of the artery and distances to the sinus floor and alveolar crest in millimeters.
- Thickness of the lateral sinus wall in milimeters.
Evaluation of alveolar bone dimensions in maxillary premolar and molar areas with ZET-MR, CBCT and directly

Time frame: Baseline-18 months
These assessments will be conducted on both preoperative CBCT and zero echo time MR images, as well as directly during surgery using a caliper.
- Repeated bone thickness measurements at 1, 3, 5, 7, and 9 mm points relative to the crest top
- The bone height from the crest top to the sinus floor at 5 mm mesiodistally from the last tooth
Evaluation of soft tissue for dental implant planning Evaluation of gingival tissue dimensions in maxillary premolar and molar areas with ZET-MR and directly during surgery

Time frame: Baseline -18 months
Gingival thickness measurements will be performed at 2, 4, and 6 mm apically from the alveolar crest through to apical area with three different methods:
- ZET-MR images in milimeters.
- Intraoral scanner images overlapped with CBCT data in milimeters.
- Clinically during dental implant surgery with a periodontal probe after local anesthesia in milimeters.

Study contacts

Contact information is provided by the study sponsor or research team.

Guliz Nigar Guncu, DDS PhD

CONTACT

[email protected]

+905337717415

Ustun Aydingoz, MD

CONTACT

[email protected]

+905326231139

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Zero Echo Time MR for the Assessment of Maxillary Sinus, Bone and Soft Tissues in the Maxillary Premolar and Molar Areas

Acronym: ZTE-DENTAL

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jun 10, 2024
Registry last updated: Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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