The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
NCT Number: NCT06533397
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alveolar Bone Loss|Edentulism Nos
Interventions: PROCEDURE: Sinus floor elevation (SFE)|DIAGNOSTIC_TEST: preoperative cone beam computed tomography (CBCT)|DIAGNOSTIC_TEST: postoperative CBCT|DIAGNOSTIC_TEST: bone core biopsy|PROCEDURE: dental implant placement|PROCEDURE: fixed dental prosthesis (FDP) fabrication|DEVICE: bone grafting
Sponsor: Semmelweis University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2031-09
Locations: Semmelweis University Department of Public Dental Health, Budapest, 1088, Hungary

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.

Primary Outcome Measures: Success of the SFE, The SFE surgery is successful if no inflammatory complications occur in the 3- or 6-month-long healing period and the bone volume is sufficient for dental implant placement., 3 or 6 months|Success of the dental implants, According to The International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference.

Success (optimum health)

1. No pain or tenderness upon function
2. 0 mobility
3. less than 2 mm radiographic bone loss from initial surgery
4. No exudates in the patient's history

II. Satisfactory survival

1. No pain on function
2. 0 mobility
3. 2-4 mm radiographic bone loss
4. No exudates in the patient's history

III. Compromised survival

1. May have sensitivity on function
2. No mobility
3. Radiographic bone loss of more than 4 mm (less than1/2 of the length of the implant body)
4. Probing depth more than 7 mm
5. May have exudates in the patient's history

IV. Failure (clinical or absolute failure)

Any of the following:

1. Pain on function
2. Mobility
3. Radiographic bone loss of more than 1/2 length of the implant
4. Uncontrolled exudate
5. Implant no longer in mouth, 5 years|Success of the implant borne prostheses, Prostheses with four or fewer complications (screw loosening, decementation, chipping) that could be treated chairside., 5 years
Secondary Outcome Measures: Hisomorphometry: Percent of residual bone graft particles, The percentage of residual bone graft particle-area measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%), 3-6 months|Hisomorphometry: Percent of newly formed bone, The percentage of newly formed bone-area measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%), 3-6 months|Hisomorphometry: Percent of bone marrow, The percentage of bone marrow-area measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%), 3-6 months|Value of the percent bone volume (BV/TV) calculated from the microCT reconstructions of the bone core biopsy samples., Relative volume of calcified tissue in the selected volume. Unit: none, 3-6 months|Value of the bone surface to volume ratio (BS/TV), calculated from the microCT reconstructions of the bone core biopsy samples., Ratio of the segmented bone surface to the total volume in the region of interest. Unit: 1/mm, 3-6 months|Value of the trabecular thickness (Tb.Th.), calculated from the microCT reconstructions of the bone core biopsy samples., Mean thickness of the trabeculae, assessed using direct 3D methods. Unit: mm, 3-6 months|Value of the trabecular separation (Tb.Sp.), calculated from the microCT reconstructions of the bone core biopsy samples., Mean distance between the trabeculae, assessed using direct 3D methods. Unit: mm, 3-6 months|Value of the trabecular bone pattern factor (Tb.Pf), calculated from the microCT reconstructions of the bone core biopsy samples., Indicator of the relation between convex and concave elements in the trabecular bone structure. Tb.Pf \<0 when the trabecular bone is honeycomb-like and increases as the trabecular bone acquires a rod-like structure. Unit: none, 3-6 months|Value of the structure model index (SMI), calculated from the microCT reconstructions of the bone core biopsy samples., The estimator of the plate- versus rod-like characteristic of the trabecular bone structure, 0 for perfect plates, 3 for perfect rods, and 4 for perfect spheres. Unit: none, 3-6 months|Value of the Total porosity (Po(tot)), calculated from the microCT reconstructions of the bone core biopsy samples., Percent porosity is the volume of pores as a percent of the total volume of interest (VOI). Unit: percent (%), 3-6 months|Value of the Connectivity (Conn.), calculated from the microCT reconstructions of the bone core biopsy samples., One useful and fast algorithm for calculating the Euler connectivity in 3D is the "Conneulor". It measures what might be called "redundant connectivity", the degree to which parts of the object are multiply connected. It is a measure of how many connections in a structure can be severed before the structure falls into two separate pieces. Unit: none., 3-6 months