The Influence of Vertical Implant Position With Immediate Provisionalization on the Marginal Bone Loss: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Marginal bone loss
研究概览
简要总结
Multiple clinical studies have established high survival rates and tremendous predictability of dental implant treatment. However, a pleasant esthetic outcome is the patient's primary expectation regarding implants in the esthetic zone and several esthetic factors have been evaluated to contribute to an esthetic appearance. Among these, the midfacial soft tissue level is considered to be one of the most important factors; Cosyn and co-workers reported that among factors including soft tissue phenotype, the midfacial recession was associated with the position of the implant .
Therefore, subcrestal implant placement has been advocated as it has been associated with the reduction of crestal bone loss in cases with decreased soft tissue thickness. If the vertical soft tissues on the crest of the alveolar ridge are 2 mm or less at the time of implant placement, implants will undergo unavoidable bone resorption by establishing sufficient biologic protection. Another option was proposed by Linkevicius et al, who introduced the subcrestal implant placement as a method to accommodate the problem of thin soft tissues.
Research question:
Does the placement of delayed implants with different vertical depth affect the marginal bone loss with immediate provisionalization?
详细描述
Preservation of crestal bone is crucial and must be prioritized from the onset of implant placement. Adequate amount of peri-implant bone contributes to esthetic success and implant stability. Crestal bone contributes to both esthetics and function. Resorption of crestal bone is seen as loss of interproximal papillary support and gingival recession, which gives way to peri-implantitis and compromises esthetics.
With respect to the depth of insertion, implants can be placed at various levels in the bone, in which affects the peri-implant tissues with the surrounding marginal bone. Therefore, Placement of an implant in a deeper position with re¬spect to the bone crest (subcrestal placement) has been suggested as a method that could contribute to main¬tain the periimplant soft and hard tissues in comparison with crestal placement, though this affirmation is sub¬ject to controversy.
Rationale for conducting the research:
Limiting the extent of peri-implant bone loss has been recognized for decades to be an important aspect of long-term implant success, and stable peri-implant bone conditions play an important role in maintaining esthetics.
the opinion expressed widely in the scientific literature has been that subcrestal implant placement leads to increased crestal bone resorption. However, clinical studies addressing the implant placement depth in relation to crestal bone have been rare. Data on subcrestal versus crestal placement have mostly come from animal studies. Even fewer data are available regarding the effects of crestal versus subcrestal positioning of platform-switched implants.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •● Patients with single missing upper anterior or premolar teeth
- •Patients with minimum buccolingual width of 6 mm and mesiodistal width of 6mm
- •Patients with healthy systemic conditions.
- •Patients older than 18 years.
- •Good oral hygiene.
- •Accepts one year follow-up period (cooperative patients).
- •The patient provides informed consent.
- •Adequate Inter-arch space for implant placement.
- •Favorable occlusion (no traumatic occlusion).
- •Absence of allergy to the prescribed medications.
排除标准
- •● Patients with inadequate bone volume and/ or quality
- •Patients with local root remnants
- •Patients with inadequate wound healing
- •Patients with signs of acute infection related to the area of interest.
- •Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al., 2006).
- •Heavy smokers patients (more than 10 cigarettes per day) (Lambert, Morris and Ochi, 2000).
- •Metabolic diseases such as diabetes or hyperthyroidism as well as systemic medications such as chemotherapy or bisphosphonates
- •Pregnant or nursing women.
- •Uncooperative patients.
结局指标
主要结局
Marginal bone loss
时间窗: 1 year follow up
Crestal bone loss
次要结局
- Mid facial recession(1 year follow up)
- Gingival Thickness(1 year follow up)
- Post-operative patient satisfaction(1 year follow up)
- Implant Survival(1 year follow up)
- The pink esthetic score(1 year follow up)
研究者
RWGWanis
Assistant Lecturer
Cairo University