Alveolar Ridge Expansion by Osseodensification and Its Impact on Implant Survival and Success: A Case Series
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Bone width (mm)
研究概览
简要总结
Approximately 40 implants from patients seeking treatment at the University of Oklahoma, College of Dentistry will be recruited for this study. Osteotomies will be prepared using the osseodensification technique and implants will be placed immediately after. The implants will be from a single manufacturer (Roxolid® SLA® Bone Level Tapered; Straumann®, Institut Straumann AG, Basel, Switzerland). Volumetric analysis of alveolar ridge will be studied using intra-surgical direct measurements and CBCT imaging. A custom stent will be fabricated to standardize the clinical and radiographic measurements at 2mm, 3mm, and 4mm apical to the alveolar crest. Changes in peri-implant bone density will be analyzed on standardized periapical and bitewing radiographs, using the ImageJ software (National Institute of Health, Bethesda, Maryland, USA). Implant stability quotient (ISQ) values will be recorded with a resonance frequency analysis system (Osstell®, Gothenburg, Sweden). Calibrated examiners will assess implant survival and biological or restorative complications and failures. Sites will be evaluated throughout osseointegration and one year after final restoration is delivered.
详细描述
The purpose of this study was to determine the efficacy for alveolar ridge expansion and change in peri-implant density when prepared by the osseodensification technique. The retention of this volume throughout osseointegration and loading were evaluated. The changes in bone volume were recorded by CBCT and intra-surgical direct measurements. A standardizing stent was used for the CBCT and direct measurements with a caliper. CBCT was taken before and after osseodensification, and 1 year after delivery of final restoration. Standardized periapical and bitewing radiographs were also taken to evaluate marginal bone loss and peri-implant bone density. Calibrated examiners evaluated implant survival and failure rate, ISQ value, peri-implant pocket depth, plaque index, bleeding index, gingival index, biological and restorative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •4. Inclusion /
排除标准
- •The inclusion criteria include:
- •Adult patients ≥18 years old
- •Able to understand and sign a written informed consent form and willing to fulfil all study requirements
- •Healed edentulous ridge that is planned for an implant restoration.
- •Experimental site has not been previously augmented with xenograft
- •Experimental site has at least 2 mm of cancellous bone
- •The exclusion criteria include:
- •Uncontrolled systemic disease
- •Currently smoking >10 cigarettes/day
- •History of head/neck radiotherapy within the past five years
- •Current use of oral bisphosphonates or history of IV bisphosphonate use
- •Pregnant, expecting to become pregnant, or lactating women
- •Presence of active periodontal disease
- •Poor oral hygiene
- •Previous history of implant failure at the site
- •The early termination criteria include:
- •The researcher believes that it is not in the patient's best interest to stay in the study
- •Based on the exclusion criteria, the patient becomes ineligible to participate
- •Patient's medical condition requires interventions which preclude involvement in the study (radiation therapy, chemotherapy, etc)
- •Patient does not follow study related instructions
- •The study is suspended or canceled
研究组 & 干预措施
Versah group
The use of a Versah bur, which is an implant drill bit, is different than a standard implant drill bit, in that its use creates a more dense bone, by using a technique called osseodensification. The drill bit and technique are specific to this drill bit and protocol, resulting in denser bone for subsequent implant placement.
干预措施: Densah (Device)
结局指标
主要结局
Bone width (mm)
时间窗: 2 years
Bone width at 2, 3, 4 mm apical to edentulous alveolar ridge.
次要结局
- implant stability(2 years)
- Survival and failure rate(2 years)