NCT06309706

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

March 7, 2024

Last Update Submit

March 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Lateral wall thickness

    The thickness of the maxillary sinus lateral wall

    2019-09-01~2019-12-31

Study Arms (1)

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).

Other: No intervention

Interventions

Just observation

cross-sectional

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

edentulous ridges in the bilateral posterior maxillary area in Chinese patients

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (2)

  • 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.

    PMID: 29142655BACKGROUND
  • Monje 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.

    PMID: 28817142BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2024

First Posted

March 13, 2024

Study Start

September 1, 2019

Primary Completion

January 1, 2020

Study Completion

December 31, 2020

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations