Status:
RECRUITING
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Lead Sponsor:
Semmelweis University
Conditions:
Alveolar Bone Loss
Edentulism Nos
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- Exclusion criteria:
- .• 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
Exclusion
Key Trial Info
Start Date :
August 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2031
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06533397
Start Date
August 24 2024
End Date
September 1 2031
Last Update
November 29 2024
Active Locations (1)
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1
Semmelweis University Department of Public Dental Health
Budapest, Budapest, Hungary, 1088