跳至主要内容
临床试验/NCT07266701
NCT07266701
Enrolling By Invitation
不适用

Precision Implant Dentistry - Bite Force Registration as Risk Assessment in Dental Implant Treatment.

Malmö University1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2025年5月15日最近更新:

概览

阶段
不适用
状态
Enrolling By Invitation
发起方
Malmö University
入组人数
85
试验地点
1
主要终点
Bite force in correlation to technical and biological complications in patients with dental implant treatment

概览

简要总结

The general aim of this clinical trial is to implement clinical assessment of overload by bite force registration to enable future simple but precise risk assessment to provide individualized treatment plans.

The main questions it aims to answer are:

  • Can we risk-assess patients regarding overload based on bite force measurement before dental implant treatment?
  • Can we profile patients based on bite force to tailor precise dental implant treatment for individual patients?
  • Will this profiling lead to improved prognosis by reduced number of technical and/or biological complications?

Participants with dental implant prostheses get their bite force measured and followed every year up to 10 years to see complications.

详细描述

The general aims will be tried to answer with two studies. One prospect and one retrospective.

Specific research questions - Study 2: Prospective clinical trial analyzing bite force and technical complications in patients receiving dental implant treatment.,

  • Does bite force differ between patients who do/do not experience complications?
  • Does high bite force measurement correlate with the number of technical complications in patients receiving dental implant treatment in a normal population?
  • Can we identify at what force risk for fractures becomes significant?
  • Does high bite force correlate with peri-implant bone loss?

Patients who accept participation will attend an examination where bilateral bite force will be recorded usin Innobyte, a highly sensitive, calibrated bilateral transducer (InnobyteTM, Kube Innovation) capable of measuring wide ranges of bite forces with good accuracy using digital display not visible to the participant.

Experimental procedure Participants are instructed to abstain from using analgesics or alcohol for 24 hours before the test as well as eating, chewing gum or tobacco products 1 hour before the session.

Participants will be seated upright in a dental chair. Participants will perform one initial maximum bite force registration to familiarize themselves with the equipment. After this, the participants will be asked to bite on the padded force transducer as hard as possible (the time needed to achieve maximum bite force is determined by the subject but typically 2 to 5 seconds). Three such measurements will be recorded with a 30-second rest in between, and the average will be calculated and registered.

All tests are carried out in one experimental session that will take approximately 10 minutes.

Baseline radiographs as well as radiographs taken at follow-up visits will be reviewed for signs of bone loss. Registrations of bleeding on probing and pocket depth will be done to determine presence of peri-implant mucositis or peri-implantitis.

Any identified technical or biological complications and/or signs of wear (measured according to TWES 3.0) will be registered together with data regarding patient age and gender, type of implant restoration, restorative material, opposing dentition and time after delivery of the prosthetic construction.

Participants will be asked to answer a questionnaire evaluating orofacial pain and jaw function and factors that may affect this. The questionnaire includes initial screening questions as well as validated instruments:

  • Screening - 3Q/TMD
  • Stress - PSS-10
  • Jaw function - JFLS-8
  • Use of splint
  • Brux-Screen

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

  • Adults aged 18 years and above that understand written and spoken Swedish language.

排除标准

  • 未提供

结局指标

主要结局

Bite force in correlation to technical and biological complications in patients with dental implant treatment

时间窗: 2025-2028

次要结局

未报告次要终点

研究者

发起方
Malmö University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验