The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSemmelweis University
About this trial
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
Qualifiers
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.
Disqualifiers
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,
Trial design
Treatments tested in this trial
- Sinus floor elevation (SFE)
- preoperative cone beam computed tomography (CBCT)
- postoperative CBCT
- bone core biopsy
- dental implant placement
- fixed dental prosthesis (FDP) fabrication
- bone grafting
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov