Assessment of Relationship Between Maxillary Sinus Floor and Maxillary Posterior Teeth Root Tips Position

May 25, 2021 updated by: Sara Tarek Khater Mohamed, Cairo University

Assessment of Relationship Between Maxillary Sinus Floor and Maxillary Posterior Teeth Root Tips Position in a Sample of Egyptian Population Using CBCT: An Observational Cross-Sectional Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

II-Introduction In the human body, the first and largest, sinus to develop is the Maxillary Sinus (MS). The growth of this sinus begins in the intrauterine period of life, and reaches its maximum size and forms the shape of a pyramid by the time of the third molar eruption or at the age of approximately 21 years. The inferior wall of sinus is lined with Schneiderian membrane which is the unique lining of the nasal cavity and paranasal sinuses (Kilic et al., 2010). Normally, the thickness of the Schneiderian membrane is approximately 1 mm (Cakur B et al., 2013; Borgonovo et al., 2015).

Odontogenic sinusitis is the most common result of iatrogenic injury of Schneiderian membrane which could result in its thickening due to inflammatory reaction (Troeltzsch et al., 2015; Zirk et al., 2017). Tooth extraction, posterior maxillary dental implant placement, sinus lift, and orthognathic surgery are the main cause relations of odontogenic sinusitis. Other potential causes include periodontal and periapical diseases (Pen˜arrocha-Oltra et al., 2020).

Detailed study of the proximity of the maxillary posterior teeth root apices to the maxillary sinus floor (MSF) is a mandatory step before some procedures as endodontic procedures in order to avoid over-instrumentation or over-filling of restorative materials. Pushing foreign material into the MS may result in the spread of infection (Obayashiet al., 2004).

The condition of maxillary posterior teeth is usually examined by periapical and panoramic radiographs during routine dental visits. However, plain films are 2-dimensional to represent the 3-dimensional structures which make it difficult to evaluate the actual relation between sinus floor and adjacent teeth (Whyte et al., 2019).

Computed tomography (CT) is considered the gold standard for sinus diagnosis (Mafee et al., 2006). However, recently, cone beam computed tomography (CBCT) is widely utilized in oral and maxillofacial region and provides several advantages over traditional CT, including lower radiation dose and chair side process (Scarfe et al., 2006).

The use of CBCT to assess the presence and possible spread of infection from the periapical area to the MSF achieved prompt radiological diagnosis and allowed superior treatment options and minimized the possibility of complications (Oberli et al., 2007; Estrela et al., 2008; Nunes et al., 2016).

Several 3-D radiographic studies involving the maxillofacial region revealed apical protrusion of the maxillary root apices into the MS but with significant variation between populations (Mudgade, D. K. et al., 2018; Hameed, K. S. et al., 2020) Considering the individual variations of position between different maxillary posterior teeth, the aim of this study is to detect the relationship between maxillary sinus floor and the maxillary posterior root tips position, and to find the association between periapical lesions as well as periodontal disease and maxillary sinus mucosal thickening in a sample of Egyptian population using cone-beam computed tomography (CBCT).

6c. Specific objectives: To detect the relationship between maxillary sinus floor and root tips position of maxillary premolars versus maxillary molars

To find the association between periapical lesions and maxillary sinus mucosal thickening

To find the association between periodontal disease and maxillary sinus mucosal thickening

Hypothesis: null

Statement of the Problem Close relationship of maxillary posterior teeth root tips to maxillary sinus may lead to perforation of its floor, formation of oro-antral fistula, or root displacement into the maxillary sinus during endodontic treatment, tooth extraction, or any surgical procedure. Other conditions, including, periapical infection and periodontal diseases may have a precursor effect on the occurrence of sinus mucosal thickening. Therefore, accurate evaluation of the anatomic relationship of maxillary sinus and posterior teeth is crucial in the clinical practice for preoperative treatment planning in order to avoid such complications.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
using CBCT software in measurement the Relationship between maxillary sinus floor and root tips position of maxillary premolars versus maxillary molars
Time Frame: through study completion, an average of 1 year
Numerical data (quantitative data)
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The association between presence of periapical lesions and maxillary sinus mucosal thickening
Time Frame: through study completion, an average of 1 year
Categorical nominal data (percent)
through study completion, an average of 1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The association between presence of periodontal disease and maxillary sinus mucosal thickening
Time Frame: through study completion, an average of 1 year
Categorical nominal data (percent)
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Dina F Abdelrahim, Ass. Prof., Associate Professor Department of Oral and Maxillofacial Radiology Faculty of Dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MSF-Max. Post. teeth root tips

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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