Alveolar Ridge Expansion During Indirect Sinus Lift Procedures--A Comparison of Two Surgical Techiques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in ridge dimensions
研究概览
简要总结
The goal of this observational study is to compare two techniques routinely used to increase bone volume in the jaw prior to placing a dental implant, called osseocondensation and osseodensification. The study participants are healthy adults who are planning to get a dental implant. The main questions it aims to answer are:
- Is there a difference in wound closure and soft tissue healing following implant placement using osseocondensation versus osseodensification?
- Is there a difference in bone density around implants placed with osseocondensation versus osseodensification?
- Is there a difference in patient experience during surgery and early phases of healing with osseocondensation versus osseodensification? Researchers will compare implant sites where the osseocondensation technique was used to sites where the osseodensification technique was used to see if there are differences in the outcomes.
It is important to note that the research study will not affect what treatment the participants get. The choice of which technique to use will be made by the dentist who is treating them, based on their clinical judgement. The researchers will only compare the outcomes for the techniques.
For the research study, participants will undergo additional clinical measurements besides those done as the normal post-operative checks, and will fill out questionnaires about their experiences with the procedures. Getting the bone-increasing procedure and getting the dental implant are not part of the research study.
详细描述
Osseocondensation procedure is a surgical technique developed as an alternative to direct sinus lifting, and it is mainly involved in preparing an implant bed without performing any ostectomy. This is a technique preferred to allow the placement of longer and larger dental implants, especially in posterior upper jaws. The target is to increase the density and the volume of the spongiosa bone at apical-coronal and buccal-lingual dimensions through compression. Although success of this surgical technique has been reported through clinical studies and case reports, some complications such as vertigo have been also documented. Osseodensification technique has been recently developed as an alternative to osseocondensation. This technique uses a special drilling protocol in which the bur turns anti-clockwise and pushes the bone into the trabeculated space instead of using an osteotome. There are several in vitro, in vivo, and clinical studies exploring integrity of bone-implant interface following implant placement through osseodensification technique. However, to the investigators' knowledge, there are no clinical studies comparing this procedure to bone condensation through conventional osteotome technique. Thus, the aim of this study is to compare early healing outcomes of implants placed by using osseocondensation and osseodensification techniques.
Both surgical techniques are currently used interchangeably. The outcomes of these procedures have not been compared within the same study. Thus, the investigators believe that a clinical study comparing these two protocols for early wound healing and bone remodeling would allow clinicians to make evidence-based choices in practice.
Working hypothesis is that there are no patient centered, clinical and radiographic differences between osseocondensation and osseodensification in early peri-implant wound healing outcomes and implant stability. Specific aims: 1. To determine wound closure and soft tissue healing following implant placement by using osseocondensation and osseodensification techniques. 2. To determine changes in CBCT bone density around implant placed with osseocondensation and osseodensification techniques. 3. To evaluate patient centered outcomes during surgery and early phases of wound healing following implant placement with osseocondensation and osseodensification.
Surgical technique being used in this study will be determined by the surgeon as part of standard care (patient and site-specific indications). *Research related procedures: - Radiographic and clinical measurements and recording of the alveolar ridge prior to surgery (dental radiographs and CBCT are routinely obtained as standard of care. The investigators will be using these documents to complete more in-depth analysis of the bone). - Clinical recording of the measurements for the alveolar ridge dimensions after flap elevation and after ridge expansion (this is routinely done as standard of care. The investigators will be recording it for research purpose). - Details of the surgery including bone quality (reported by surgeon), presence of buccal dehiscence/fenestration, the need of additional bone grafting of the ridge, the indications for barrier membrane placement. - Recording of implant stability by recording torque value and/or Osstell value (initial implant stability is an important parameter for the success of the implant and is routinely determined as standard care. The investigators will be recording it as part of the study). - Questions designed to evaluate patient experience (pain and discomfort during and after surgery).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old
- •Systemically healthy
- •No contraindications for implant placement surgery
- •No chronic sinus problems
- •Non-smoker
- •Minimum ridge width of 3 mm and ridge height of 5 mm
排除标准
- •need for ENT specialist clearance due to active problems in relation to ear, not, throat related chronic problems
- •sufficient bone volume to perform implant placement without ridge augmentation
- •Require guided bone regeneration prior to implant placement
- •Need to wear a removable temporary restoration during healing
研究组 & 干预措施
Osseodensification
Patients who are having the sinus lift procedure using the osseodensification technique
干预措施: Sinus lift using osseodensification technique (Procedure)
Osseocondensation
Patients who are having the sinus lift procedure using the osseocondensation technique
干预措施: Sinus lift using the osseocondensation technique (Procedure)
结局指标
主要结局
Change in ridge dimensions
时间窗: Day of surgery and day of uncovery (4-6 months post-surgery)
Dimensions of the alveolar ridge, determined by measurements on the surgical stent and the CBCT images
Change in Bone Density
时间窗: Day of procedure and day of uncovery (4-6 months post-operative)
Bone density around the dental implant, measured via CBCT
次要结局
- Healing Score Index 8-10 days PO(8-10 days following the surgical procedure)
- Wound Healing 8-10 days PO(8-10 days following the surgical procedure)
- Wound Healing 6-8 weeks PO(6-8 weeks following the surgical procedure)
- Initial Implant Stability(Intraoperative)
- Final Implant Stability(4-6 months post-surgery)
- Healing Score Index 6-8 weeks PO(6-8 weeks following the surgical procedure)
- Patient Experience 6-8 Weeks PO(6-8 weeks after surgery)
- Patient Experience 4-6 months PO(4-6 months after surgery)
- Patient Experience Day of Surgery(surgical procedure)
- Patient Experience 8-10 Days PO(8-10 days after surgery)
研究者
Binnaz Leblebicioglu
Professor
Ohio State University
