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临床试验/NCT05670340
NCT05670340已完成不适用

Effect of Bone-related and Soft-tissue-related Variables on the Marginal Bone Loss of Platform-matched and Platform Switched Dental Implants

University of Salamanca2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年1月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Change in the Peri-implant Marginal Bone level

研究概览

简要总结

In this clinical trial the effect of the implant-abutment morphology (platform-switched vs platform matched) will be assessed in both soft tissue (soft tissue thickness) and hard tissue (marginal bone loss) outcomes. Several clinical predictors (initial implant position level, gingival biotype, abutment height and prosthetic emergence profile) will also be taken into account as modulating factors of the clinical outcome.

详细描述

This prospective clinical trial is conducted at the Dental Clinic of the Faculty of Medicine of the University of Salamanca. The protocol was developed in accordance with the 1975 Declaration of Helsinki, and later approved by the Bioethics Committee of the University of Salamanca with the number (Ref:473/2020)

Before initiating any procedure, each patient received information about the study design and signed an informed consent. The subjects are recruited consecutively following the admission protocols of the Dental Clinic of the Faculty of Medicine of the University of Salamanca, Salamanca, Spain. The inclusion criteria are:

(1) Patients of legal age (>18 years); (2) in need of at least one maxillary or mandibular dental implant to be inserted in mature bone (more than 4 months after tooth extraction) in the posterior area (premolars and molars); (3) with good oral hygiene (plaque and gingival index ≤ 25%). The exclusion criteria included clinical conditions that contraindicated implant surgery, (1) patients with immunological alterations, pregnant and lactating, (2) heavy smokers > 20 cigarettes/day, (3) with the need for bone or soft tissue augmentations, (4) patients whose anatomy prevented the correct three-dimensional placement of the implant to perform prosthetically guided screwed restorations.

All implants were placed by an experienced implantologist following standard procedures and the manufacturer's recommendations. All implants were connected to a transmucosal abutment to heal in one-stage approach. Several variables were collected in this surgical phase (bone quality, implant stability, implant-bone level, mucosal thickness, keratinized mucosa width ...)

After 3 to 4 months of implant healing all the clinical parameters were reevaluated and the final impression will be used for the manufacturing of a porcelain-fused to metal screwed crowns.

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
Double (Participant, Outcomes Assessor)

盲法说明

only the care provider knows the group asignement

入排标准

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

入选标准

  • Patients of legal age (>18 years).
  • With rehabilitation needs with 1 maxillary or mandibular implant in mature bone (more than 4 months after tooth extraction) in the posterior sector (premolars and molars).
  • With good hygiene (plaque and gingival index ≤ 25%).

排除标准

  • Medical conditions that contraindicated implant surgery.
  • Patients with immunological alterations, pregnant and lactating.
  • Heavy smokers > 20 cigarettes/day,
  • Requiring bone augmentations or of soft tissues.
  • Patients whose anatomy prevented the correct three-dimensional placement of the implant to perform prosthetically guided screw-retained restorations.

结局指标

主要结局

Change in the Peri-implant Marginal Bone level

时间窗: At baseline (reference), in comparison with 3, 6 and 12 months

The implant-bone level is assesssed radiographicly

Change in the Implant stablity quotient

时间窗: At baseline (reference), and in comparison with the 3 months follow-up

The ISQ is assesssed by Osstell

Change in the Gingival Thickness

时间窗: At baseline (reference) and in comparison with the 3, 6 and 12 months follow-up

The gingival thickness will be assessed by measuring the keratinized region around implants with a periodontal probe and a thickness caliper

次要结局

未报告次要终点

研究者

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

JAVIER MONTERO

Full Professor in Prosthodontics

University of Salamanca

研究点 (2)

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