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临床试验/NCT06177275
NCT06177275招募中不适用

The Influence of Vertical Implant Position With Immediate Provisionalization on the Marginal Bone Loss in Thick Versus Thin Phenotype. A Randomized Controlled Clinical Trial.

Cairo University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Crestal 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 (Schiegnitz and Al-Nawas 2018). However, a pleasant esthetic outcome is the patient's primary expectation regarding implants in the esthetic zone (Vermylen et al. 2003)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 (Cosyn et al. 2012).

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.(Linkevicius et al. 2020).

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 (Laurell and Lundgren, 2011).

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 (Cochran et al., 2009).

This study aims to compare the effect of different vertical implant position with immediate provisionalization on marginal bone loss thin and thick vertical tissue biotype.

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
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Crestal bone loss

时间窗: 1 year

Interproximal bone loss will be measured using paralleling cone technique with standardized peri-apical x-ray and bone loss will be measured mesial and distal to the implant by measuring the vertical bone loss from the initial implant position at T3 immediately after implant position and T4 (6 months) and T5 (12 months), ,where interproximal bone loss will be defined as the distance from implant shoulder to the mesial and distal first visible bone-implant contact (fBIC) and (b) bone over the implant platform. One independent and calibrated examiner (A.P.) measured these radiological variables to the nearest 0.1 mm (Pico et al., 2019).

次要结局

  • Radiographic horizontal bucco-palatal bone changes(1 year)
  • Esthetic evaluation(1 year)
  • implant survival(1 year)
  • Radiographic vertical bone changes(1 year)
  • Midfacial recession (MFR):(easured at 6, and 12 months)
  • Emergence Angle(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nesma Mohamed Fouad Shemais

Lecturer in the department of Oral Medicine & Periodontology

Cairo University

研究点 (2)

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