Zero Echo Time MR for the Assessment of Maxillary Sinus and Dental Regions (ZTE-DENTAL)

September 30, 2024 updated by: Guliz N. Guncu, Hacettepe University

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Guliz Nigar Guncu, DDS PhD
  • Phone Number: +905337717415
  • Email: gngun1@gmail.com

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Recruiting
        • Department of Periodontology, Faculty of Dentistry, Hacettepe University,
        • Contact:
          • Guliz Nigar Guncu, DDS PhD
          • Phone Number: 00-90-533-771-74-15
        • Sub-Investigator:
          • Guliz N. Guncu, DDS PhD
      • Ankara, Turkey, 06230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  1. Thickness of the sinus membrane in millimeters.
  2. Shape of thickening (dome shape or flat).
  3. 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'.
  4. Presence and variations of the posterior superior alveolar artery (intraosseous or below the membrane or on the outer cortex of the lateral sinus wall)
  5. Diameter of the artery and distances to the sinus floor and alveolar crest in millimeters.
  6. Thickness of the lateral sinus wall in milimeters.
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

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
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

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:

  1. ZET-MR images in milimeters.
  2. Intraoral scanner images overlapped with CBCT data in milimeters.
  3. Clinically during dental implant surgery with a periodontal probe after local anesthesia in milimeters.
Baseline -18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 27, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HacettepeU21351

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Edentulous Alveolar Ridge

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe