NCT06533397 The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
| NCT ID | NCT06533397 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Semmelweis University |
| Condition | Alveolar Bone Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-08-24 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-08-24 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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
Contact & Investigator
Márton Kivovics, DMD,MSD,PHD
PRINCIPAL INVESTIGATOR
Department of Public Dental Health, Semmelweis University
Frequently Asked Questions
Who can join the NCT06533397 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Alveolar Bone Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06533397 currently recruiting?
Yes, NCT06533397 is actively recruiting participants. Contact the research team at kivovics.marton@semmelweis.hu for enrollment information.
Where is the NCT06533397 trial being conducted?
This trial is being conducted at Budapest, Hungary.
Who is sponsoring the NCT06533397 clinical trial?
NCT06533397 is sponsored by Semmelweis University. The principal investigator is Márton Kivovics, DMD,MSD,PHD at Department of Public Dental Health, Semmelweis University. The trial plans to enroll 40 participants.