The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

August 24, 2024

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2031

Conditions
Alveolar Bone LossEdentulism Nos
Interventions
PROCEDURE

Sinus floor elevation (SFE)

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.

DIAGNOSTIC_TEST

preoperative cone beam computed tomography (CBCT)

A CBCT scan is performed before SFE surgery to evaluate the anatomy and pathologies of the maxillary sinus.

DIAGNOSTIC_TEST

postoperative CBCT

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.

DIAGNOSTIC_TEST

bone core biopsy

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.

PROCEDURE

dental implant placement

Following the 3- or 6-month-long healing period following SFE, dental implants are placed non-submerged in the augmented bone under local anesthesia.

PROCEDURE

fixed dental prosthesis (FDP) fabrication

3 months after dental implant placement, fixed dental prostheses are delivered on the dental implants.

DEVICE

bone grafting

A synthetic bone graft material (Bond Apatite, Augma Biomaterials, Cesarea, Israel) is used during SFE.

Trial Locations (1)

1088

RECRUITING

Semmelweis University Department of Public Dental Health, Budapest

All Listed Sponsors
lead

Semmelweis University

OTHER