The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
- Conditions
- Edentulism NosAlveolar Bone Loss
- Interventions
- Procedure: Sinus floor elevation (SFE)Diagnostic Test: preoperative cone beam computed tomography (CBCT)Diagnostic Test: postoperative CBCTDiagnostic Test: bone core biopsyProcedure: dental implant placementProcedure: fixed dental prosthesis (FDP) fabricationDevice: bone grafting
- Registration Number
- NCT06533397
- Lead Sponsor
- Semmelweis University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
Exclusion criteria:
.• Patients who had major systemic diseases as classified by the American Society of Anesthesiologists (ASA grades III-IV),
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 6-month healing period bone grafting 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. 3-month healing period fixed dental prosthesis (FDP) fabrication 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. 6-month healing period Sinus floor elevation (SFE) 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. 6-month healing period fixed dental prosthesis (FDP) fabrication 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. 6-month healing period preoperative cone beam computed tomography (CBCT) 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. 6-month healing period postoperative CBCT 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. 3-month healing period bone grafting 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. 6-month healing period bone core biopsy 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. 3-month healing period Sinus floor elevation (SFE) 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. 3-month healing period preoperative cone beam computed tomography (CBCT) 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. 3-month healing period postoperative CBCT 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. 3-month healing period bone core biopsy 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. 3-month healing period dental implant placement 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. 6-month healing period dental implant placement 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.
- Primary Outcome Measures
Name Time Method Success of the SFE 3 or 6 months 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.
Success of the dental implants 5 years 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 mouthSuccess of the implant borne prostheses 5 years Prostheses with four or fewer complications (screw loosening, decementation, chipping) that could be treated chairside.
- Secondary Outcome Measures
Name Time Method Hisomorphometry: Percent of residual bone graft particles 3-6 months The percentage of residual bone graft particle-area measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%)
Value of the Connectivity (Conn.), calculated from the microCT reconstructions of the bone core biopsy samples. 3-6 months 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.
Hisomorphometry: Percent of bone marrow 3-6 months The percentage of bone marrow-area measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%)
Value of the percent bone volume (BV/TV) calculated from the microCT reconstructions of the bone core biopsy samples. 3-6 months Relative volume of calcified tissue in the selected volume. Unit: none
Value of the bone surface to volume ratio (BS/TV), calculated from the microCT reconstructions of the bone core biopsy samples. 3-6 months Ratio of the segmented bone surface to the total volume in the region of interest. Unit: 1/mm
Value of the trabecular thickness (Tb.Th.), calculated from the microCT reconstructions of the bone core biopsy samples. 3-6 months Mean thickness of the trabeculae, assessed using direct 3D methods. Unit: mm
Value of the trabecular separation (Tb.Sp.), calculated from the microCT reconstructions of the bone core biopsy samples. 3-6 months Mean distance between the trabeculae, assessed using direct 3D methods. Unit: mm
Value of the trabecular bone pattern factor (Tb.Pf), calculated from the microCT reconstructions of the bone core biopsy samples. 3-6 months 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
Value of the structure model index (SMI), calculated from the microCT reconstructions of the bone core biopsy samples. 3-6 months 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
Hisomorphometry: Percent of newly formed bone 3-6 months The percentage of newly formed bone-area measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%)
Value of the Total porosity (Po(tot)), calculated from the microCT reconstructions of the bone core biopsy samples. 3-6 months Percent porosity is the volume of pores as a percent of the total volume of interest (VOI). Unit: percent (%)
Trial Locations
- Locations (1)
Semmelweis University Department of Public Dental Health
🇭🇺Budapest, Hungary