Osteotome Sinus Floor Elevation With or Without Grafting: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Endo-sinus bone gain at 12-month
研究概览
简要总结
The osteotome sinus floor elevation (OSFE) technique has been proved to be a predictable procedure for successful implant placement in posterior maxillae with limited bone height under sinus. OSFE is considered to be minimal invasive and minimal traumatic while having a limitation with regard to the residual bone height. According to the consensus conference in 1996, OSFE technique without bone grafting should be limited to RBH ranging from 7mm to 9mm. However, recent studies reported favorable results even with RBH of around 4mm. Moreover, there is still controversy regarding the necessity of a grafting material in order to maintain the space for new bone formation. Spontaneous bone formation was observed for OSFE without grafting by some researches.
Due to the lack of randomized controlled trial (RCTs), there is still no clear guideline for implant therapy in posterior maxillae with limited bone height. Neither is there any evidence to recommend or contraindicate the application of grafting materials in combination with OSFE.
The present RCT is aimed to evaluate the clinical success of OSFE with RBH of 2mm to 8 mm and to study whether the application of grafting material in combination with OSFE will be more favorable. The hypothesis is that the application of simultaneous grafting has no significant advantage in terms of clinical success. Spontaneous bone formation can be observed with implants placed using OSFE without grafting.
45 systemically healthy adults consecutively admitted for oral implant therapy will be randomly assigned to 2 test groups. Only one implant system will be used to minimize the implant-originated influencing factors. Bio-Oss® will be chosen as the bone substitute as it is currently the typical xenograft available. Autogenous bone will be also used as it is deemed as 'gold standard' for bone graft materials.
A panoramic radiograph and cone-beam CT should be taken to assess the pretreatment bone height under sinus. For T1 group, the autogenous bone chips harvested during the drilling procedure will be mixed up with Bio-Oss®. And the mixture is placed into the 'socket' by osteotomes when elevating the sinus membrane until the final depth. For T2 group, no grafting materials will be used. The subjects will be recalled for follow-up visits at 3 months, 6 months, 1 year, 2 years, 3 years,5years and 10 years after surgery for clinical and radiographic examination. Implant protrusion length, endo-sinus bone gain and crestal bone level will be measured on the radiographs using specialized software. ANOVA will be performed for the success rates of the 2 groups. Descriptive statistics will be used for the radiographic parameters.
The present study is aimed to provide preliminary evidence for an important clinical question that whether OSFE is predictable and reliable with RBH of less than 6mm and whether the application of grafting materials is necessary for this indication.
详细描述
-
Specific aims
-
To evaluate the clinical success of implants placed in posterior maxillae with limited residual bone height (2mm to 8 mm) using OSFE with or without simultaneous grafting
-
To study the influence of simultaneous grafting on the clinical success of dental implants in posterior maxillae using OSFE
-
To observe the bone changes in the elevated space under sinus with or without grafting.
The null hypothesis is that the application of simultaneous grafting has no significant advantage in terms of clinical success. Spontaneous bone formation can be observed with implants placed using OSFE without grafting. 2. Background and significance
Posterior maxillae commonly pose a challenge for successful dental implants due to the poor bone quality and insufficient bone quantity. Efforts have been made to allow successful implant placement in the posterior maxilla subject to limited bone height under the sinus. Approaches available now include the application of tilting implants, short implants, sinus floor elevation technique, etc. The osteotome sinus floor elevation (OSFE) technique, first introduced by Tatum in 1986, has been proved to be a predictable procedure. For OSFE, access to the sinus membrane is achieved through a crestal approach. Therefore, compared with window technique, OSFE is considered to be less invasive and less traumatic while having a limitation with regard to the residual bone height. According to the consensus conference in 1996, OSFE technique should be limited to RBH ranging from 7mm to 9mm. However, with the improvement of implant design and surgical technique, the high predictability of implant therapy has encouraged re-evaluation of this limitation. Favorable results have been reported with more compromised sites even with RBH of around 4mm. Moreover, there is controversy regarding the necessity of a grafting material in order to maintain the space for new bone formation. In a previous pilot study, 42 implants was placed in posterior maxillae with OSFE without bone grafting materials. The RBH ranged from 4mm to 8mm (average 6.36mm). The 5-month result also demonstrated predictable results.
But to date, there is still insufficient data regarding the clinical results of the implants in posterior maxilla with OSFE technique without grafting and it still remains to be elucidated the necessity of grafting with OSFE. And the lack of well-designed RCTs makes the level of evidence relatively low. In this context, therefore, the applicants attempt to assess the clinical success of dental implants placed in posterior maxillae using OSFE with or without grafting and to observe the endo-sinus bone changes specially for RBH of only 2mm to 8 mm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •partial edentulism in the maxillary posterior region for at least 6 months from tooth loss
- •residual bone height ranged from 2mm to 8mm (measured on pre-surgical radiograph)
- •sufficient bone width in edentulous region
- •systemic and local condition compatible with implant placement and sinus floor elevation
- •willing to provide informed consent and capable to comply the study protocol.
排除标准
- •uncontrolled diabetes mellitus or other systemic disorders
- •uncontrolled periodontal conditions, endodontic lesions or other oral disorders
- •heavy smokers (≥ 10 cigarettes per day)
- •rhinitis or sinusitis
- •insufficient residual bone quality to achieve implant stability
- •previous implant installation or bone grafting at the surgical site
研究组 & 干预措施
OSFE with grafting
OSFE with grafting (autogenous bone chips+xenograft material with a ratio of 1:4)
干预措施: SLA dental implants (Device)
OSFE with grafting
OSFE with grafting (autogenous bone chips+xenograft material with a ratio of 1:4)
干预措施: Osteotome sinus floor elevation (Procedure)
OSFE with grafting
OSFE with grafting (autogenous bone chips+xenograft material with a ratio of 1:4)
干预措施: Bone grafting (Procedure)
OSFE without grafting
OSFE without grafting. No grafting materials or autogenous bone chips were used.
干预措施: Osteotome sinus floor elevation (Procedure)
OSFE without grafting
OSFE without grafting. No grafting materials or autogenous bone chips were used.
干预措施: SLA dental implants (Device)
结局指标
主要结局
Endo-sinus bone gain at 12-month
时间窗: 12-month follow-up
Radiographic assessment was conducted on periapical radiographs at every follow-up visit using paralleling technique. The endo-sinus bone gain of both groups were assessed on radiography.
Endo-sinus bone gain at 6-month
时间窗: 6-month follow-up
Radiographic assessment was conducted on periapical radiographs at every follow-up visit using paralleling technique. The endo-sinus bone gain of both groups were assessed on radiography.
Endo-sinus bone gain at 60-month
时间窗: 60-month follow-up
Radiographic assessment was conducted on periapical radiographs at every follow-up visit using paralleling technique. The endo-sinus bone gain of bothgroups were assessed on radiography.
Endo-sinus bone gain at 24-month
时间窗: 24-month follow-up
Radiographic assessment was conducted on periapical radiographs at every follow-up visit using paralleling technique. The endo-sinus bone gain of both groups were assessed on radiography.
Endo-sinus bone gain at 36-month
时间窗: 36-month follow-up
Radiographic assessment was conducted on periapical radiographs at every follow-up visit using paralleling technique. The endo-sinus bone gain of both groups were assessed on radiography.
Endo-sinus bone gain at 10-year
时间窗: 10-year follow-up
Radiographic assessment was conducted on periapical radiographs at every follow-up visit using paralleling technique. The endo-sinus bone gain of bothgroups were assessed on radiography.
次要结局
- Surgical and post-surgical complications and discomfort(3 hours after surgery)
研究者
Junyu Shi
Chair of Oral and Maxillo-facial Implantology Department
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University