Edentulous Alveolar RidgeZTE-DENTALNCT06449443
Zero Echo Time MR for the Assessment of Maxillary Sinus and Dental Regions
An observational study of Edentulous Alveolar Ridge, run by Hacettepe University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge
- How many people
- 20 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- All maxillary teeth missing
- With active periodontitis
- Under 18 years of age
- Individuals who did not approve the informed consent form.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Department of Periodontology, Faculty of Dentistry, Hacettepe University,
Ankara, 06100
Guliz Nigar Guncu, DDS PhD, 00-90-533-771-74-15
Guliz N. Guncu, DDS PhD
- Recruiting
Hacettepe University Faculty of Medicine
Ankara, 06230
Ustun Aydingoz, ustunaydingoz@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Edentulous Alveolar Ridge
- Keywords
- ZTE MRI, CBCT, Intraoral Scanner, Maxillary Posterior Zone, Dental Implant
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of maxillary sinus area with ZET-MR
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.
Measured: 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
Measured: 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:
- 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.
Measured: Baseline -18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Jul 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guliz N. Guncu, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449443
- Sponsor's protocol ID
- HacettepeU21351
- Acronym
- ZTE-DENTAL
- Status last verified
- Sep 2024
- First submitted
- 27 May 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zero Echo Time MR for the Assessment of Maxillary Sinus, Bone and Soft Tissues in the Maxillary Premolar and Molar Areas
- ClinicalTrials.gov ID
- NCT06449443
- Acronym / sponsor ID
- ZTE-DENTAL / HacettepeU21351
- Conditions
- Edentulous Alveolar Ridge
- Keywords
- ZTE MRI, CBCT, Intraoral Scanner, Maxillary Posterior Zone, Dental Implant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- All maxillary teeth missing
- With active periodontitis
- Under 18 years of age
- Individuals who did not approve the informed consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edentulous Alveolar Ridge, run by Hacettepe University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guliz Nigar Guncu, DDS PhD (+905337717415, gngun1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of maxillary sinus area with ZET-MR (time frame: Baseline-18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024; AzTrials last refreshed its copy on 1 Nov 2026.