Clinical trial NCT06449443: Zero Echo Time MR for the Assessment of Maxillary Sinus and Dental Regions
Official title: Zero Echo Time MR for the Assessment of Maxillary Sinus, Bone and Soft Tissues in the Maxillary Premolar and Molar Areas
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Edentulous Alveolar Ridge
Keywords: ZTE MRI
CBCT
Intraoral Scanner
Maxillary Posterior Zone
Dental Implant
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with missing teeth in the maxillary premolar and molar regions who applied to Faculty of Dentistry Department of Periodontics for dental implant treatment and who had cone beam computed tomography images for pre-surgical bone evaluation.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of maxillary sinus area with ZET-MR
timeFrame: Baseline-18 months
measure: Evaluation of alveolar bone dimensions in maxillary premolar and molar areas with ZET-MR, CBCT and directly
timeFrame: Baseline-18 months
measure: 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
timeFrame: Baseline -18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Department of Periodontology, Faculty of Dentistry, Hacettepe University,
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Medicine
Study officials:
References: