NCT04903418

Brief Summary

There have been no cross-sectional studies conducted on the Egyptian population studying the relationship between maxillary sinus floor and the maxillary posterior root tips position using CBCT, and whether the maxillary sinus mucosal thickening is associated with periapical lesions as well as periodontal disease. Such study will raise the diagnostic and interpretational abilities of dental radiologists and decision making of oral surgeons and endodontists.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

May 27, 2021

Status Verified

May 1, 2021

Enrollment Period

8 months

First QC Date

May 19, 2021

Last Update Submit

May 25, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • using CBCT software in measurement the Relationship between maxillary sinus floor and root tips position of maxillary premolars versus maxillary molars

    Numerical data (quantitative data)

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • The association between presence of periapical lesions and maxillary sinus mucosal thickening

    through study completion, an average of 1 year

Other Outcomes (1)

  • The association between presence of periodontal disease and maxillary sinus mucosal thickening

    through study completion, an average of 1 year

Interventions

* Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database. * All the CBCT examinations will be obtained for patients who were scanned using CBCT Software (Planmeca Romexis® Viewer software). * CBCT images will be analysed in different planes.

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The CBCT data of this study will be obtained from the CBCT data base available at the department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University, Cairo, Egypt. Being a retrospective study, CBCT scans of Egyptian patients who have already been subjected to CBCT examination as part of their dental diagnosis and/or treatment planning will be included according to the proposed eligibility criteria.

You may qualify if:

  • CBCT scans for patients aged from 20 to 70 years.
  • CBCT scans for patients with at least first and second maxillary premolars and first and secon maxillary molars present on one side (fully erupted teeth and fully formed apices).
  • CBCT scans taken for pre-evaluation of endodontic treatment, implant placement, impacted teeth removal, obstructive sleep apnea treatment, pre-orthodontic or pre-prosthetic evaluation.
  • Good quality CBCT scans.

You may not qualify if:

  • CBCT scans for patients with no maxillary posterior teeth.
  • CBCT scans for patients with history of maxillary sinus operation (including sinus floor elevation).
  • CBCT scans for patients with sign or history of non-odontogenic sinusitis, including air-fluid level, thickening of all the sinus walls and maxillary sinus polyps.
  • CBCT scans for patients with syndromes, congenital or developmental anomalies.
  • CBCT scans for patients with bone disease.
  • CBCT scans for patients with traumatic injuries to the maxillofacial region.
  • Low quality CBCT scans (any artifact).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Maxillary Sinusitis

Condition Hierarchy (Ancestors)

SinusitisRespiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Dina F Abdelrahim, Ass. Prof.

    Associate Professor Department of Oral and Maxillofacial Radiology Faculty of Dentistry

    STUDY DIRECTOR

Central Study Contacts

Sara T Khater, Master

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 26, 2021

Study Start

October 1, 2021

Primary Completion

June 1, 2022

Study Completion

July 1, 2022

Last Updated

May 27, 2021

Record last verified: 2021-05