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临床试验/NCT06528587
NCT06528587已完成不适用

Rehabilitation of Single Aesthetic Areas Using Narrow Diameter Implants With Computer Guided Implant Insertion: a Prospective Study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2024年9月1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
入组人数
17
试验地点
2
主要终点
peri-implant marginal bone loss in millimeters

研究概览

简要总结

The scientific literature does not provide scientific evidence on how to manage patients suffering from monoedentulism with ridges having a reduced bone thickness or a reduced mesio-distal space. Narrow diameter implants could be a solution to rehabilitate patients suffering from these clinical conditions while avoiding longer, more complex and sometimes even multidisciplinary therapies. However, there is a lack of clinical studies analyzing the outcomes of rehabilitation with narrow diameter implants.

详细描述

Dental implants are considered a predictable rehabilitation option in the event of tooth extraction or missing tooth. In some cases, the inevitable resorption of the alveolar ridge after tooth extraction can make the insertion of dental implants difficult or even impossible without the use of more advanced bone regeneration procedures. Narrow diameter implants represent an alternative treatment option in areas with limited ridge width. Narrow alveolar ridges and limited interdental or inter-implant spaces continue to pose a challenge to the clinician. In the case of a narrow ridge, two options are available: the first option is to insert a standard diameter implant following bone augmentation procedures; the second option is to use an implant with a narrow diameter. Regarding the mesio-distal gap, an adequate distance between teeth and implants is necessary to reduce subsequent bone resorption and recession of the papillae. Difficult clinical situations with limited mesio-distal space or reduced ridge width can be overcome by using narrow diameter implants. Correct three-dimensional implant positioning is the key factor to obtain, in addition to good integration, favorable prosthetic results and a good long-term aesthetic result. To optimize the insertion of the implants, reducing the intrinsic imprecision of the conventional free-hand technique, computer-guided static surgery protocols can be used to plan the angulation, position and depth of the implant with a digital software. Narrow diameter implants therefore have their own indication for the replacement of lateral incisors of the maxilla and for the incisors of the mandible.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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 who have undergone implant surgery to perform implant rehabilitation of single edentulism in the anterior region to insert a reduced diameter implant;
  • ASA I and ASA II patients;
  • Age > 18yr;
  • Non-smokers or smokers ≤ 5 cig/day;
  • Achievement of FMPS and FMBS ≤ 15%;
  • Signing of the written informed consent to participate in the study.

排除标准

  • Severe general medical pathologies;
  • Immunodeficiency states;
  • Radiotherapy in the head and neck region;
  • Uncontrolled diabetes or hypertension;
  • Smokers >5 cigs/day;
  • Impossibility to carry out homogeneous and continuous follow-up;
  • Documented allergy to the biomaterials used;
  • Pregnancy or breastfeeding;
  • Inability to provide written informed consent.

研究组 & 干预措施

narrow diameter implant

Patients who have performed computer-guided implant surgery for the rehabilitation of single edentulism in the anterior region with lack of adequate bone thickness or mesio-distal space using implants with narrow diameter.

干预措施: narrow diameter implant (Procedure)

结局指标

主要结局

peri-implant marginal bone loss in millimeters

时间窗: 12 months from implant placement

evaluation of the peri-implant marginal bone loss in millimeters

次要结局

  • soft tissue evaluation in millimeters(12 months from implant placement)
  • biological complication rate in percentage(12 months from implant placement)
  • mechanical complication rate in percentage(12 months from implant placement)
  • esthetics(12 months from implant placement)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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