Lateral Wall ThicknessNCT06309706
A Retrospective Cone Beam Computed Tomography Study of The Lateral Wall Bony Window
An observational study of Lateral Wall Thickness, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
Three experienced observers were asked to screen all the CBCT images from the Stomatology Hospital,Zhejiang University School of Medicine, between September 1, 2019 and December 31, 2019, and counted 1000 maxillary sinus CBCT images that met the criteria. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Wall Thickness
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 31 Dec 2020
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: edentulous ridges in the bilateral posterior maxillary area in Chinese patients
Who may be able to join
- Images were included if the following criteria were met: (1) patients were 18 years or older, (2) presence of teeth adjacent to or opposing the edentulous area allowing the location of the edentulous ridges corresponding to the tooth site to be identified, (3) presence of maxillary dentition defect in any tooth positon of the second premolar, the first molar or the second molar, (4) the maxillary sinus to be measured was visible from its floor to at least 15 mm high.
Who cannot join
- Images were excluded if any of the following criteria were met: (1) images were unclear or incomplete due to scattering or other reasons, (2) pristine maxillary posterior extraction sites after less than 3 months of healing and the tooth extraction sockets could be obviously identified, (3) the maxillary sinus had been grafted for implant-supported prosthesis, (4) implants or other prosthetic devices were present in maxillary posterior edentulous position, (5) orthodontic brackets and wires in images were present; (6) the location of the edentulous sites could not be determined, (7) sinus pathology was present that made the measurement impossible.
Trial locations and contacts
1 site in 1 country.
China1 site
Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
Three experienced observers were asked to screen all the CBCT images from the Stomatology Hospital,Zhejiang University School of Medicine, between September 1, 2019 and December 31, 2019, and counted 1000 maxillary sinus CBCT images that met the criteria. Later, 1000 CBCT images were further measured and analyzed, and indicators such as maxillary sinus buccal wall thickness, morphology, whether there is blood vessel or not, whether there is bone septa or not were counted. The variation rules and related factors were summarized by SPSS analysis.
- Conditions
- Lateral Wall Thickness
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Just observation
| Study group | Role | What they receive |
|---|---|---|
| cross-sectional | To analyze the maxillary sinus anatomy over edentulous ridges in the bilateral posterior maxillary area in Chinese patients using cone-beam computed tomography (CBCT). Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lateral wall thickness
The thickness of the maxillary sinus lateral wall
Measured: 2019-09-01~2019-12-31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Sep 2019
- Primary completion1 Jan 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lateral Wall ThicknessStudies of the same condition, open and under way.
- 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Dental Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309706
- Sponsor's protocol ID
- JXHU
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Starch-Jensen T, Jensen JD. Maxillary Sinus Floor Augmentation: a Review of Selected Treatment Modalities. J Oral Maxillofac Res. 2017 Sep 30;8(3):e3. doi: 10.5037/jomr.2017.8303. eCollection 2017 Jul-Sep.
PubMed 29142655Monje A, Urban IA, Miron RJ, Caballe-Serrano J, Buser D, Wang HL. Morphologic Patterns of the Atrophic Posterior Maxilla and Clinical Implications for Bone Regenerative Therapy. Int J Periodontics Restorative Dent. 2017 Sep/Oct;37(5):e279-e289. doi: 10.11607/prd.3228.
PubMed 28817142
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cone Beam Computed Tomography Study of The Lateral Wall Bony Window
- ClinicalTrials.gov ID
- NCT06309706
- Acronym / sponsor ID
- JXHU
- Conditions
- Lateral Wall Thickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- The Dental Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 Mar 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.
Three experienced observers were asked to screen all the CBCT images from the Stomatology Hospital,Zhejiang University School of Medicine, between September 1, 2019 and December 31, 2019, and counted 1000 maxillary sinus CBCT images that met the criteria. Later, 1000 CBCT images were further measured and analyzed, and indicators such as maxillary sinus buccal wall thickness, morphology, whether there is blood vessel or not, whether there is bone septa or not were counted. The variation rules and related factors were summarized by SPSS analysis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cross-sectional | – | Other: No interventionTo analyze the maxillary sinus anatomy over edentulous ridges in the bilateral posterior maxillary area in Chinese patients using cone-beam computed tomography (CBCT). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- edentulous ridges in the bilateral posterior maxillary area in Chinese patients
Key inclusion criteria (1 listed)
- Images were included if the following criteria were met: (1) patients were 18 years or older, (2) presence of teeth adjacent to or opposing the edentulous area allowing the location of the edentulous ridges corresponding to the tooth site to be identified, (3) presence of maxillary dentition defect in any tooth positon of the second premolar, the first molar or the second molar, (4) the maxillary sinus to be measured was visible from its floor to at least 15 mm high.
Key exclusion criteria (1 listed)
- Images were excluded if any of the following criteria were met: (1) images were unclear or incomplete due to scattering or other reasons, (2) pristine maxillary posterior extraction sites after less than 3 months of healing and the tooth extraction sockets could be obviously identified, (3) the maxillary sinus had been grafted for implant-supported prosthesis, (4) implants or other prosthetic devices were present in maxillary posterior edentulous position, (5) orthodontic brackets and wires in images were present; (6) the location of the edentulous sites could not be determined, (7) sinus pathology was present that made the measurement impossible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionJust observation | Other | cross-sectional |
Primary outcome
Lateral wall thickness
Time frame: 2019-09-01~2019-12-31
The thickness of the maxillary sinus lateral wall
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Background: PubMed 29142655Starch-Jensen T, Jensen JD. Maxillary Sinus Floor Augmentation: a Review of Selected Treatment Modalities. J Oral Maxillofac Res. 2017 Sep 30;8(3):e3. doi: 10.5037/jomr.2017.8303. eCollection 2017 Jul-Sep.
- Background: PubMed 28817142Monje A, Urban IA, Miron RJ, Caballe-Serrano J, Buser D, Wang HL. Morphologic Patterns of the Atrophic Posterior Maxilla and Clinical Implications for Bone Regenerative Therapy. Int J Periodontics Restorative Dent. 2017 Sep/Oct;37(5):e279-e289. doi: 10.11607/prd.3228.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lateral Wall Thickness, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lateral wall thickness (time frame: 2019-09-01~2019-12-31). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06309706, which also lists 2 linked publications.
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 13 Mar 2024.