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Chronic SinusitisNCT06773494

Clinical and Radiographic Evidence of Alleviation of Preoperative Chronic Sinusitis After Open Sinus Allogeneic Bone Augmentation Surgery: A Retrospective Observational Study

An observational study of Chronic Sinusitis and Open Sinus Elevation, run by Misr International University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to evaluate the impact of open sinus elevation technique on chronic sinusitis when combined with simultaneous dental implant placement. A retrospective analysis of patients with chronic sinusitis who underwent sinus elevation and dental implant procedures was performed. Read more about this study

Who is it for?
Any age
Conditions the study is for
Chronic Sinusitis, Open Sinus Elevation
How many people
36 participants
Where
1 siteEgypt
Study dates
29 May 2024to 30 Jun 2024
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 Any age
  • All sexes
  • Child, Adult, Older adult

Study population: The current research was performed on 36 sinuses selected from patients in Oral and Maxillofacial outpatients' clinics at the Faculty of Dentistry, Suez Canal University, who underwent sinus lifting procedures to increase alveolar ridge height for simultaneous implant placement. The study was planned as a comparative retrospective study under the World Medical Association Declaration of Helsinki. All clinical and radiographic data will be acquired through the screening of saved patients' files, radiographs and a patient filled questionnaire. The selected patients' records fulfilled selective criteria.

Who may be able to join

  • 1. Males and females ≥ 18 years of age. 2. ASA I and ASA II. 3. Patients having partial edentulism in the posterior region of the maxilla. 4. Edentulous sites consist of native non augmented bone. 5. Horizontal ridge dimension minimum of 5mm 6. The vertical ridge dimension 4-7 mm. 7. Bone quality of D2 or D3. 8. Enough inter-arch distance. 9. The presence of one-year postoperative radiograph CBCT. 10. Presence of postoperative follow up clinical data.

Who cannot join

  • 1. Patients with active acute infection or residual lesion related to the edentulous sites.
  • 2. Acute maxillary sinus pathosis 3. A remaining root dislodged in the Maxillary sinus. 4. Patients that lack a stable occlusion or have parafunctional habits. 5. Patients with poor oral hygiene who are not amenable to motivation and improvement.
  • 6. Smokers who smoke more than 10 cigarettes a day. 7. Pregnant or lactating mothers. 8. Alcohol and drug abuse. 9. Treatment with radiation therapy in the craniofacial region within the previous 12 months.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Suez Canal University

    Ismailia, 41522

Other trials in Egypt

About this study

Official title: Long-term Clinical and Radiographic Evidence of Alleviation of Preoperative Chronic Sinusitis After Open Sinus Allogeneic Bone Augmentation Surgery: A Retrospective Observational Study

The aim of this study is to evaluate the impact of open sinus elevation technique on chronic sinusitis when combined with simultaneous dental implant placement. A retrospective analysis of patients with chronic sinusitis who underwent sinus elevation and dental implant procedures was performed. Radiographic images were analyzed preoperatively and postoperatively to assess the fluid levels in the sinuses. Clinical evaluation through a questionnaire tabulated by an ENT specialist was done for all patients. The results showed the following: Preoperative radiographs showed varying fluid levels in the sinuses. Postoperative results demonstrated that fluid levels were either entirely eliminated or significantly reduced in all cases. Therefore, it can be concluded that sinus elevation procedures, when performed concurrently with dental implants, can alleviate chronic sinusitis symptoms as evidenced by reduced fluid levels in the sinus cavities.

Read the detailed description

Introduction Implant placement in the posterior maxilla may be a dilemma. Factors complicating the treatment may be anatomical landmarks, type of bone, residual bone height, limited accessibility, maxillary sinus pneumatization as well as sinus pathologies such as chronic or acute sinusitis (1,2).

When vertical bone in the posterior maxilla is compromised due to maxillary sinus pneumatization several protocols were advocated to overcome this occurrence, such as the placement of short implants (3), 2nd premolar occlusion (4), or maxillary sinus elevation (5). Sinus elevation was introduced in 1980 when Boyne and James presented the lateral window approach as a modification of the Caldwell- Luc technique; access to lift the sinus floor is performed by a window through the lateral wall of the sinus (6). This technique was proven to be effective and successful for sinus elevation, even up to 12 mm in cases of severely atrophic ridge (7). It was later divided into three techniques according to the lateral wall preparation: hinge, elevated, and complete (8).

The high position of the Maxillary Sinus Ostium (MSO) led to the fact that drainage of the sinus is always against the gravitational force, an important factor that may lead to fluid precipitation inside the sinus and needs to be considered when dealing with maxillary sinusitis (9).

The presence of pre-operative sinus pathologies, including chronic and acute sinusitis may complicate the treatment of open sinus elevation as they may affect the integrity of the Schneiderian membrane at the time of open sinus elevation (10). Not only so, but they may also increase the risk of post-operative sinusitis (11).

However, a research gap exists in this aspect since a systematic review published in 2021 negated that suggestion and mentioned that mucosal thickenings of the Schneiderian membrane and/ or chronic sinusitis are not likely to pause extra risk factors in terms of sinus augmentation (12).

Patients and Methods

Patient Selection:

The current research was performed on 36 sinuses selected from patients in Oral and Maxillofacial outpatients' clinics at the Faculty of Dentistry, Suez Canal University, who underwent sinus lifting procedures to increase alveolar ridge height for simultaneous implant placement. The study was planned as a comparative retrospective study under the World Medical Association Declaration of Helsinki. All clinical and radiographic data will be acquired through the screening of saved patients' files, radiographs and a patient filled questionnaire. The selected patients' records fulfilled selective criteria.

Inclusion Criteria:

  1. Males and females ≥ 18 years of age.
  2. ASA I and ASA II.
  3. Patients having partial edentulism in the posterior region of the maxilla.
  4. Edentulous sites consist of native non augmented bone.
  5. Horizontal ridge dimension minimum of 5mm
  6. The vertical ridge dimension 4-7 mm.
  7. Bone quality of D2 or D3.
  8. Enough inter-arch distance.
  9. The presence of one-year postoperative radiograph CBCT.
  10. Presence of postoperative follow up clinical data.

Exclusion Criteria:

  1. Patients with active acute infection or residual lesion related to the edentulous sites.
  2. Acute maxillary sinus pathosis
  3. A remaining root dislodged in the Maxillary sinus.
  4. Patients that lack a stable occlusion or have parafunctional habits.
  5. Patients with poor oral hygiene who are not amenable to motivation and improvement.
  6. Smokers who smoke more than 10 cigarettes a day.
  7. Pregnant or lactating mothers.
  8. Alcohol and drug abuse.
  9. Treatment with radiation therapy in the craniofacial region within the previous 12 months.

Surgical protocol:

All the surgical procedures were performed by the same surgeon using standardized techniques under aseptic conditions. Open sinus elevation was done with simultaneous implant placement with allogenic bone graft. The follow up period for all patients was one year.

Outcomes assessment:

Clinical outcomes:

Clinical examination was done by an ENT specialist, where the patient filled a questionnaire (formulated by the ENT specialist) which was used to determine the presence or absence of symptoms of chronic sinusitis.

Radiographic outcomes:

All subjects were evaluated for presence or absence of chronic sinusitis in the preoperative CBCT and one-year follow up CBCT. Fusion module was used to accurately compare both CBCTs by superimposing the postoperative CBCT on the preoperative CBCT.

Chronic sinusitis is identified as the presence of thickening of Schneiderian membrane ≥ 2 mm, mucosal cyst, polyp, or fluid level (13).

Statistical Plan:

Sample size calculation:

This power analysis used bone height gain as the primary outcome. The effect size f = (3.2349048) was calculated based upon the results of Hammuda \& ghoneim 2021 (13) and assuming that the standard deviation within each group = 0.8, using alpha level of 5% and Beta level of 20% i.e. power = 80%. The minimum estimated sample size was 8 samples per group. Sample size calculation was done using G*Power version 3.1.9.2

Keywords
open sinus elevation, lateral window, dental implants, chronic sinusitis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic outcome

    All subjects were evaluated for presence or absence of chronic sinusitis in the preoperative CBCT and one-year follow up CBCT. Fusion module was used to accurately compare both CBCTs by superimposing the postoperative CBCT on the preoperative CBCT.

    Chronic sinusitis is identified as the presence of thickening of Schneiderian membrane ≥ 2 mm, mucosal cyst, polyp, or fluid level.

    Measured: 1 year

Secondary outcomes (1)
  1. Clinical outcome

    Clinical examination was done by an ENT specialist, where the patient filled a questionnaire (formulated by the ENT specialist) which was used to determine the presence or absence of symptoms of chronic sinusitis.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2025
  2. Study start29 May 2024
  3. Primary completion30 Jun 2024
  4. Study completion30 Jun 2024

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06773494
Sponsor's protocol ID
2024/518
Status last verified
Jan 2025
First submitted
8 Jan 2025
Last updated
14 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • El Sholkamy MA, Mattar HA, Mohamed MH, Keraa KM, Nasr TA, Hussein WA. Evidence of chronic sinusitis alleviation after open sinus allogeneic bone augmentation with simultaneous implant placement: A long-term retrospective observational study. Oral Maxillofac Surg. 2025 Dec 19;30(1):8. doi: 10.1007/s10006-025-01482-9.

    PubMed 41417228

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Sinusitis and Open Sinus Elevation, run by Misr International University at 1 site in Egypt.

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 3 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 14 Jan 2025. 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 Egypt. 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?

Radiographic outcome (time frame: 1 year). 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 NCT06773494, which also lists 1 linked publication.

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 14 Jan 2025.

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Clinical Trial NCT06773494 | AzTrials