The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
概览
- 阶段
- 不适用
- 干预措施
- postoperative CBCT
- 疾病 / 适应症
- Alveolar Bone Loss
- 发起方
- Semmelweis University
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Success of the SFE
- 状态
- 招募中
- 最后更新
- 8天前
概览
简要总结
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.
研究者
Marton Kivovics
associate professor
Semmelweis University
入排标准
入选标准
- •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.
排除标准
- •.• 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.
研究组 & 干预措施
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.
干预措施: postoperative CBCT
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.
干预措施: Sinus floor elevation (SFE)
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.
干预措施: preoperative cone beam computed tomography (CBCT)
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.
干预措施: postoperative CBCT
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.
干预措施: bone core biopsy
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.
干预措施: dental implant placement
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.
干预措施: fixed dental prosthesis (FDP) fabrication
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.
干预措施: bone grafting
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.
干预措施: Sinus floor elevation (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.
干预措施: preoperative cone beam computed tomography (CBCT)
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.
干预措施: bone core biopsy
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.
干预措施: dental implant placement
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.
干预措施: fixed dental prosthesis (FDP) fabrication
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.
干预措施: bone grafting
结局指标
主要结局
Success of the SFE
时间窗: 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
时间窗: 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 mouth
Success of the implant borne prostheses
时间窗: 5 years
Prostheses with four or fewer complications (screw loosening, decementation, chipping) that could be treated chairside.
次要结局
- Hisomorphometry: Percent of residual bone graft particles(3-6 months)
- Value of the Connectivity (Conn.), calculated from the microCT reconstructions of the bone core biopsy samples.(3-6 months)
- Hisomorphometry: Percent of bone marrow(3-6 months)
- Value of the percent bone volume (BV/TV) calculated from the microCT reconstructions of the bone core biopsy samples.(3-6 months)
- Value of the bone surface to volume ratio (BS/TV), calculated from the microCT reconstructions of the bone core biopsy samples.(3-6 months)
- Value of the trabecular thickness (Tb.Th.), calculated from the microCT reconstructions of the bone core biopsy samples.(3-6 months)
- Value of the trabecular separation (Tb.Sp.), calculated from the microCT reconstructions of the bone core biopsy samples.(3-6 months)
- Value of the trabecular bone pattern factor (Tb.Pf), calculated from the microCT reconstructions of the bone core biopsy samples.(3-6 months)
- Value of the structure model index (SMI), calculated from the microCT reconstructions of the bone core biopsy samples.(3-6 months)
- Hisomorphometry: Percent of newly formed bone(3-6 months)
- Value of the Total porosity (Po(tot)), calculated from the microCT reconstructions of the bone core biopsy samples.(3-6 months)