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

NCT06449443 | Recruiting DMC

• 1 other identifier: HacettepeU21351
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Edentulous Alveolar Ridge

Keywords

ZTE MRI; CBCT; Intraoral Scanner; Maxillary Posterior Zone; Dental Implant

Outcome Measures

Primary Outcomes (3)

• Evaluation of maxillary sinus area with ZET-MR

  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

  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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (2)

Department of Periodontology, Faculty of Dentistry, Hacettepe University,

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Hacettepe University Faculty of Medicine

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Guliz Nigar Guncu, DDS PhD

CONTACT

+905337717415; gngun1@gmail.com

Ustun Aydingoz, MD

CONTACT

+905326231139; ustunaydingoz@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 10, 2024
• Study Start: July 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

TU (2)