The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Semmelweis University
40 participants
Aug 24, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria12
- • 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
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Interventions
Patients rinse with 0.2% chlorhexidine solution for one minute before surgery. Under local anesthesia, a mucoperiosteal flap is raised from a midcrestal incision and two relieving incisions. Lateral window osteotomies are carried out using diamond burs. The Schneiderian membrane is carefully elevated and the synthetic bone graft material (Bond Apatite, Augma Biomaterials, Cesarea, Israel) (2-3 cm3) is packed in the defect with light force. The buccal flap is then mobilized to allow tension-free primary closure. The margins are stabilized with single interrupted sutures. Antibiotics (1 g amoxicillin-clavulanate twice a day for 5 days, or in case of side effects or known allergy to penicillin, 300 mg clindamycin 4 times a day for 4 days), anti-inflammatory drugs (50 mg diclofenac 3 times a day for 3 days), and chlorhexidine mouthwash (twice a day for 21 days from the first day after surgery) are prescribed. Suture removal takes place after 10 days.
A CBCT scan is performed before SFE surgery to evaluate the anatomy and pathologies of the maxillary sinus.
A CBCT scan is performed following the 3- or 6-month-long healing period after SFE to evaluate the anatomy and healing of the augmented bone and the maxillary sinus.
At the time of dental implant placement, the first step of the implant bed preparation is performed using a trephine drill to harvest a bone core biopsy sample from the augmented bone. The biopsy sample is harvested from the implant bed, this way the patient is spared of excess surgical burden as this bone would be removed even if no biopsy sample was harvested during dental implant placement. The bone core biopsy samples are subjected to histomorphometric and microCT analysis.
Following the 3- or 6-month-long healing period following SFE, dental implants are placed non-submerged in the augmented bone under local anesthesia.
3 months after dental implant placement, fixed dental prostheses are delivered on the dental implants.
A synthetic bone graft material (Bond Apatite, Augma Biomaterials, Cesarea, Israel) is used during SFE.
Locations(1)
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NCT06533397