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

NCT06773494 | Completed

• 1 other identifier: 2024/518
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Sinusitis; Open Sinus Elevation

Keywords

open sinus elevation; lateral window; dental implants; chronic sinusitis

Outcome Measures

Primary Outcomes (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.

  1 year

Secondary Outcomes (1)

• Clinical outcome

  1 year

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \. 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.

You may not qualify if:

• \. Patients with active acute infection or residual lesion related to the edentulous sites.
• \. 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.
• \. 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.

Sponsors & Collaborators

• Misr International University: lead
• Suez Canal University: collaborator

Study Sites (1)

Suez Canal University

Ismailia, 41522, Egypt

Location

Study Officials

• Hebatullah A Mattar, Assistant Lecturer

  Misr International University

  PRINCIPAL INVESTIGATOR

• Wael A Hussein, Assistant Lecturer

  Misr International University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 14, 2025
• Study Start: May 29, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 14, 2025

Record last verified: 2025-01

Locations

EG (1)