The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
NCT ID: NCT06533397
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-08-24
2031-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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3-month healing period
Staged SFE is performed; following a 3-month-long healing period, bone core biopsy samples are harvested from the augmented bone, and dental implants are placed.
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.
preoperative cone beam computed tomography (CBCT)
A CBCT scan is performed before SFE surgery to evaluate the anatomy and pathologies of the maxillary sinus.
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.
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.
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.
fixed dental prosthesis (FDP) fabrication
3 months after dental implant placement, fixed dental prostheses are delivered on the dental implants.
bone grafting
A synthetic bone graft material (Bond Apatite, Augma Biomaterials, Cesarea, Israel) is used during SFE.
6-month healing period
Staged SFE is performed; following a 6-month-long healing period, bone core biopsy samples are harvested from the augmented bone, and dental implants are placed.
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.
preoperative cone beam computed tomography (CBCT)
A CBCT scan is performed before SFE surgery to evaluate the anatomy and pathologies of the maxillary sinus.
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.
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.
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.
fixed dental prosthesis (FDP) fabrication
3 months after dental implant placement, fixed dental prostheses are delivered on the dental implants.
bone grafting
A synthetic bone graft material (Bond Apatite, Augma Biomaterials, Cesarea, Israel) is used during SFE.
Interventions
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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.
preoperative cone beam computed tomography (CBCT)
A CBCT scan is performed before SFE surgery to evaluate the anatomy and pathologies of the maxillary sinus.
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.
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.
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.
fixed dental prosthesis (FDP) fabrication
3 months after dental implant placement, fixed dental prostheses are delivered on the dental implants.
bone grafting
A synthetic bone graft material (Bond Apatite, Augma Biomaterials, Cesarea, Israel) is used during SFE.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who need dental implant-borne prostheses,
* Patients with insufficient bone height in the posterior maxilla due to sinus pneumatization.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Semmelweis University
OTHER
Responsible Party
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Marton Kivovics
associate professor
Principal Investigators
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Márton Kivovics, DMD,MSD,PHD
Role: PRINCIPAL_INVESTIGATOR
Department of Public Dental Health, Semmelweis University
Locations
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Semmelweis University Department of Public Dental Health
Budapest, Budapest, Hungary
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SEDCD44
Identifier Type: -
Identifier Source: org_study_id