The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Recruiting now · Not applicable
Conditions studied: Alveolar Bone Loss, Edentulism Nos
In brief
Pneumatization of the maxillary sinus may lead to insufficient bone volume for dental implant placement in the edentulous posterior maxilla. Sinus floor elevation (SFE) surgery with the lateral window technique is a safe and predictable surgical intervention to restore bone height in the maxillary premolar and molar areas. According to the literature, several bone graft materials may be successfully applied for SFE surgery. There is a lack of evidence regarding the application of biphasic calcium sulfate (BCS) for SFE. The healing period following staged SFE is 2-9 months. The aim of this study is: * to evaluate the success of SFE surgery using BCS as graft material, * to compare the microarchitecture of the augmented bone depending on the healing period, * to evaluate the success of dental implants placed in the augmented bone and that of the prostheses delivered on the dental implants.
Key facts
- Study ID
- NCT06533397
- Run by
- Semmelweis University
- People needed
- 40
- Starts
- 2024-08-24
- Expected to finish
- 2031-09-01
- Last updated by the study team
- 2026-04-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients over the age of 18 years,
- Patients who need dental implant-borne prostheses,
- Patients with insufficient bone height in the posterior maxilla due to sinus pneumatization.
You may not qualify if…
- .• Patients who had major systemic diseases as classified by the American Society of Anesthesiologists (ASA grades III-IV),
- psychiatric contraindications,
- patients on medication interfering with bone metabolism, including steroid therapy and antiresorptive medication,
- radiation to the head or neck region within the previous five years,
- localized periapical disease, odontogenic and nonodontogenic cysts, and maxillary sinusitis,
- evidence of uncontrolled periodontal disease,
- Alcohol Use Disorder defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5),
- recreational drug abuse,
- heavy smoking (>10 cigarettes/day),
- diseases of the oral mucosa, including blisters and ulcers, i.e.: red and white lesions, pigmented lesions, benign tumors of the oral cavity, and oral cancer. Leukoplakia, Erythroplakia, Precancerous lesions, Oral squamous cell carcinoma and malign tumors of the soft and hard tissues, Oral candidiasis, Oral lichen planus, Psoriasis, Pemphigus, and Pemphigoid.
- pregnancy or nursing,
- poor oral hygiene
Where it is running
- Semmelweis University Department of Public Dental Health — Budapest, Budapest, Hungary (enrolling)
Full record on ClinicalTrials.gov
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