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临床试验/NCT07574710
NCT07574710已完成不适用

Effects of Implant Placement Depth (4 mm Versus 6 mm) on Crestal Bone Stability in Immediate Implant Placement: A Clinical Study With 1-Year Post-Restorative Results

Tomas Linkevicius1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2021年2月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
1
主要终点
Marginal bone loss around dental implant

研究概览

简要总结

The aim of a study was to analyze the effect of implant placement depth (4 mm versus 6 mm below the mid-facial gingival margin) on marginal bone loss (MBL) around implant and implant stability during immediate implant placement after tooth extraction. Clinical trial was conducted involving 35 patients requiring immediate implant placement after tooth extraction. Implants were placed either 4 mm (control group) or 6 mm (test group) below the mid-facial gingival margin. Primary outcome was deemed to be radiographic assessment of marginal bone level from periapical radiographs. Secondary outcome was implant stability quotient registration using resonance freaquency analyzer. The null hypothesis is that there is no significant difference in peri-implant marginal bone loss between implants placed at 4 mm depth versus 6 mm depth relative to the buccal gingival margin during immediate implant placement.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •1) age ≥ 18 years; (2) generally healthy individuals with no medical contraindications for implant surgery; (3) healthy soft tissue, indicated by bleeding on probing (BOP) < 20% and Plaque Index (PI) < 25%; (4) keratinized gingiva ≥ 2 mm, both buccally and lingually; (5) presence of molar or premolar in the upper or lower jaw; (6) implant primary stability ≥ 35 Ncm; (7) intact alveolar bone walls post-extraction; (8) one study implant per patient; and (9) signed informed consent with permission to utilize data for research purposes

排除标准

  • •(1) smoking (≥ 10 cigarettes/day); (2) history of uncontrolled periodontitis; (3) uncontrolled diabetes or alcoholism; (4) medications known to impair healing; and (5) implant primary stability < 35 Ncm

研究组 & 干预措施

4 mm

Active Comparator

干预措施: Implants were positioned 4 mm below the mid-facial gingival margin (Procedure)

6 mm

Experimental

干预措施: Implant was placed 6 mm below free gingival margin (Procedure)

结局指标

主要结局

Marginal bone loss around dental implant

时间窗: From implant restoration delivery till 1 year follow-up

次要结局

  • Implant stability quotient(After implant placement and after 4 months)

研究者

发起方
Tomas Linkevicius
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tomas Linkevicius

Professor

Lithuanian University of Health Sciences

研究点 (1)

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