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Recruiting NCT06449443

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

Observational Edentulous Alveolar Ridge

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Edentulous Alveolar Ridge. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Evaluation of maxillary sinus area with ZET-MR [Time frame: Baseline-18 months]
  • Evaluation of alveolar bone dimensions in maxillary premolar and molar areas with ZET-MR, CBCT and directly [Time frame: Baseline-18 months]
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

Turkey (Türkiye) · 2 centers
  • Department of Periodontology, Faculty of Dentistry, Hacettepe University, — Ankara
  • Hacettepe University Faculty of Medicine — Ankara

Identifiers

NCT: NCT06449443 · HacettepeU21351

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗