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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Hungary
Semmelweis University Department of Public Dental Health
RECRUITING
Budapest
Contact Information
Primary
Márton Kivovics, DMD,MSD,PHD
kivovics.marton@semmelweis.hu
003614591500
Backup
Dorottya Pénzes, DMD,MSD,PHD
dorottya.penzes@semmelweis.hu
003614591500
Time Frame
Start Date: 2024-08-24
Estimated Completion Date: 2031-09
Participants
Target number of participants: 40
Treatments
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Semmelweis University

This content was sourced from clinicaltrials.gov