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临床试验/NL-OMON20945
NL-OMON20945招募中不适用

Comparison of hybrid and moderate rough implants in periodontally compromised patients: a 3-year randomized clinical trail

ACTA Dental Research B.V., Gustav Mahlerlaan 3004, 1081 LA, Amsterdam, The Netherlands0 个研究点目标入组 43 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
43

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • Age at least 18 years
  • -Provision of written informed consent
  • -Agree to return for follow-up visits after 1, 2 and 3 years
  • -Periodontally compromised patients having a history of proximal attachment loss of > 5mm in > 30% of teeth present and enrolled in a supportive periodontal therapy (SPT) program after active periodontal treatment
  • -Requirement of two single-unit fixed partial dentures (FPDs supported by two implants in mandibular premolar and/or molar region
  • -Adjacent natural tooth/teeth
  • -In antagonistic jaw natural teeth, partial prosthesis, or implant supported (partial) prosthesis in contact with planned FPD
  • -History of edentulism in planned implant area > 4 months
  • -At planned implant area, a minimum of 12 mm bone in vertical dimension and minimum of 6 mm in horizontal dimension available
  • -Acquiring a primary stable implant situation assumed by investigator

排除标准

  • -History of local radiotherapy to the head and neck region
  • -History of chemotherapy < 5 years prior to surgery
  • -Smoking > 10 cigarettes a day
  • -Uncontrolled diabetes mellitus
  • -Known or suspected current malignancy
  • -Pregnancy at time of inclusion
  • -Alcohol or drug abuse
  • -Any systemic or local disease that would compromise postoperative healing and/or osseointegration
  • -Need for systemic bisphosphonates, corticosteroids or any other medication that would compromise postoperative healing and/or osseointegration
  • -History of systemic bisphosphonates
  • -Presence of active clinical periodontal disease expressed by probing pocket depths > 5 mm and bleeding on probing
  • -History of necrotic or rapid progressive periodontitis
  • -Untreated caries and/or endodontic disease
  • -Previous implant loss
  • -Previous bone augmentation in planned implant area
  • -Severe grinding/clenching habits
  • -Incapability of performing oral hygiene as a result of physical or mental disorders
  • -During any period of the study, if any mandatory procedures and measurements are missing by the investigator, the dataset of that subject will be removed from the final results.

研究者

发起方
ACTA Dental Research B.V., Gustav Mahlerlaan 3004, 1081 LA, Amsterdam, The Netherlands

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