Horizontal Ridge Augmentation With Guided Bone Regeneration Using Particulate Xenogenic Bone Substitutes With or Without Autogenous Block Grafts: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Changes in horizontal alveolar ridge width from pre-operatively (baseline) to 12 months after implant loading.
研究概览
简要总结
To evaluate dimensional bone alterations following horizontal ridge augmentation using guided bone regeneration (GBR) with or without autogenous block graft (ABG) for the rehabilitation of atrophic jaws with dental implants.
详细描述
Forty-two patients with 42 severe horizontal bone atrophy sites in the maxilla or mandible will be randomly assigned to two groups: ABG or GBR.
In the ABG group, a combination of ABG with particulate xenograft, covered with collagen membrane, will be used, while only a combination of particulate xenograft and collagen membrane alone will be in the GBR group. After 6-9 months of healing, implants were inserted. All implants will be definitively restored 6 months after implant placement. Radiographic examination (cone beam computed tomograms, CBCT) will be performed to evaluate the amount of horizontal bone width (HBW) gain immediately after bone grafting procedure (T0), at 6 months (T6), and at 18 months (T18). Patient demographic information, amount of width augmentation, implant survival, complications, and contributing factors will be gathered and analyzed.
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)
盲法说明
Outcome measurements will be recorded by an examiner, who will not participate in any study procedure, and will be blind to the allocated treatment. This blinded examiner will be trained and calibrated to perform measurements. A dentist who is blinded to the treatment protocol will performe all radiographic measurements.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years old, who required an implant supported restoration in at least one site, with severe atrophy of the alveolar ridge in the horizontal plane (class III-IV atrophy according to Cawood and Howell classification),
- •adequate oral hygiene
- •no history of previous bone augmentation procedures at the implant site, and
- •able to understand and sign an informed consent form.
排除标准
- •uncontrolled systemic conditions, irradiation in the head and neck area, - immunosuppressed or immunocompromised,
- •presented with oral disorders (such as lichen planus),
- •treated or under treatment with intravenous amino-bisphosphonates,
- •untreated periodontitis, poor oral hygiene and motivation,
- •parafunctional habits,
- •pregnant or lactating,
- •drug or alcohol abuse,
- •psychiatric disorders,
- •a history (within the last 3 months) of using (at least weekly or more frequently) smokeless chewing tobacco, smoking a pipe, cigar or cigarette (at a rate of more than 10 cigarettes per day),
- •acute/chronic infection/inflammation in the area, or
- •an extraction with less than 3 months of healing
研究组 & 干预措施
Alveolar ridge augmentation without ABG
Horizontal ridge augmentation using guided bone regeneration without autogenous block graft (ABG)
干预措施: Horizontal ridge augmentation (Procedure)
Alveolar ridge augmentation with ABG
Horizontal ridge augmentation using guided bone regeneration with autogenous block graft (ABG).
干预措施: Horizontal ridge augmentation (Procedure)
结局指标
主要结局
Changes in horizontal alveolar ridge width from pre-operatively (baseline) to 12 months after implant loading.
时间窗: From pre-operatively (baseline) to 12 months after implant loading.
Horizontal alveolar ridge changes in being assessed in the regenerated area. This outcome will be evaluated from pre-operatively (baseline), to 12 months after implant loading by measuring the alveolar ridge width at various points on the cross-sectional images using data obtained from CBCT scans.
次要结局
- Implant failure(At 6 months (T6), and at 18 months (T18) after implant placement.)
- Regrafting necessity(At 6 months (T6).)
- Complications(6 months)