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临床试验/NCT06463405
NCT06463405招募中不适用

Patient Perception and Oral Function of Implant-supported Restorations Replacing Posterior Teeth

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年3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
20
试验地点
2
主要终点
Oral Health Related Quality of Life score

研究概览

简要总结

The overall aim is to evaluate the patient-reported outcome and efficiency of replacing posterior teeth with implant-supported crowns compared to RDPs and no treatment. Sub-aims are to evaluate a new 3D-methods for registration of occlusion and to test two crown designs.

Thus, the study design has three aims:

  • To analyze patient perception including OHRQoL, when missing posterior teeth are replaced with implant-supported crowns compared to removable dental prostheses (RDPs) or no replacement.
  • To develop and validate new 3D digital methods for assessing occlusal contacts between upper and lower jaw and to analyze the methods relation to masticatory ability and efficiency.
  • To compare the difference in biological technical outcomes between splinted and non-splinted implant-supported crowns over time.

详细描述

Hypotheses

  • No difference in patient perception of mastication and OHRQoL between no treatment, RDPs and implant-supported crowns in the posterior region
  • No difference between two different digital techniques (T-scan and 3D Intraoral scanning) in measuring the occlusal contact points and area.
  • No difference in biological and technical outcomes between splinted and non-splinted implant-supported crowns

Material and methods. Participants Partially edentulous subjects with missing posterior teeth (Kennedy class I or class II) in the upper or lower jaw, in need for fixed implant-supported crowns to replace the missing teeth are offered to be enrolled if they fulfill the following inclusion criteria. The participants must be in good health and with no contraindications for undergoing dento-alveolar surgery.

Subjects presenting with the following conditions will be excluded from the study:

  • Untreated or active, progressive periodontitis
  • Intake of (high dose) antiresorptive medicine or earlier medication related osteonecrosis of the jaw
  • Therapeutic radiation to the head and neck
  • Uncontrolled diabetes or systemic corticosteroids
  • Heavy smoking (>20 cigarettes/day)
  • An inability to open the mouth wide enough to place implants
  • Decayed or unrestored anterior/premolar teeth
  • Need for major bone augmentation (e.g., bone block graft, extensive augmentations with second operation for implant insertion)
  • < 8 mm bone height to the alveolar nerve or sinus maxillaris
  • Parafunctional habits or untreated temporomandibular dysfunctions or orofacial pain
  • Unable to cooperate or too ill to complete the experiment
  • Lack of signed informed consent A participant, who no longer wishes to participate in the trial, can withdraw her/his informed consent at any time. Withdrawn subjects can give information of which aspects of the trial she/he wishes to withdraw from.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Partially edentulous subjects with missing posterior teeth (Kennedy class I or class II) in the upper or lower jaw, in need for fixed implant-supported crowns to replace the missing teeth are offered to be enrolled if they fulfill the following inclusion criteria. The participants must be in good health and with no contraindications for undergoing dento-alveolar surgery.

排除标准

  • Untreated or active, progressive periodontitis
  • Intake of (high dose) antiresorptive medicine or earlier medication related osteonecrosis of the jaw
  • Therapeutic radiation to the head and neck
  • Uncontrolled diabetes or systemic corticosteroids
  • Heavy smoking (>20 cigarettes/day)
  • An inability to open the mouth wide enough to place implants
  • Decayed or unrestored anterior/premolar teeth
  • Need for major bone augmentation (e.g., bone block graft, extensive augmentations with second operation for implant insertion)
  • < 8 mm bone height to the alveolar nerve or sinus maxillaris
  • Parafunctional habits or untreated temporomandibular dysfunctions or orofacial pain
  • Unable to cooperate or too ill to complete the experiment
  • Lack of signed informed consent

结局指标

主要结局

Oral Health Related Quality of Life score

时间窗: Up to 5 years

Oral Function change in percentage

时间窗: Up to 5 years

Marginal Bone Loss in mm

时间窗: Up to 5 years

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

Klaus Gotfredsen

Professor

University of Copenhagen

研究点 (2)

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