Maxillary SinusitisNCT04903418
Assessment of Relationship Between Maxillary Sinus Floor and Maxillary Posterior Teeth Root Tips Position
An observational study of Maxillary Sinusitis, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Maxillary Sinusitis
- What is being tested?
- CBCT software
- Type of treatment
- Medical device
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Jul 2022
- 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 20 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Maxillary Sinusitis
- Being tested
- CBCT software
- Medical subject headings
- Maxillary Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCT softwareDevice
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
The association between presence of periapical lesions and maxillary sinus mucosal thickening
Categorical nominal data (percent)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study startOct 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary SinusitisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Tarek Khater Mohamed, Cairo University
- Investigators
- Dina F Abdelrahim, Ass. Prof., Study director, Associate Professor Department of Oral and Maxillofacial Radiology Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903418
- Sponsor's protocol ID
- MSF-Max. Post. teeth root tips
- Status last verified
- May 2021
- First submitted
- 19 May 2021
- Last updated
- 27 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04903418
- Acronym / sponsor ID
- MSF-Max. Post. teeth root tips
- Conditions
- Maxillary Sinusitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 26 May 2021 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| CBCT software* 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. | Device | – |
Primary outcome
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)
1 secondary outcome
The association between presence of periapical lesions and maxillary sinus mucosal thickening
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
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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.
Dina F Abdelrahim, Ass. Prof. study director
Associate Professor Department of Oral and Maxillofacial Radiology Faculty of Dentistry
Questions about this trial
What is this clinical trial studying?
An observational study of Maxillary Sinusitis, run by Cairo University.
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 4 inclusion and 7 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 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Sara T Khater, Master (01065836744, sara.khater@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 27 May 2021.