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Completed

NCT Number: NCT04129957

Prediction of Failure of Dental Implants

The aim of the study is to identify predictors in patient profiles and implant characteristics and to develop and calibrate a prediction model for failure of implants. Patients' demographic characteristics, lifestyle habits, general health, dental health, and implant characteristics were regarded as potential predictors. The failure of implants and the follow-up time in days of implants were considered the outcome. Multivariate Cox proportional hazards regression analysis is used to find out the important risk factors for failure of dental implants and to develop the model for prediction of failure of dental implants at follow-up. The performance and clinical values of the model is determined.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Academic Centre for Dentistry in Amsterdam

Amsterdam, North Holland, 1081LA, Netherlands

About this study

During the past decades, dental implant therapy has developed into a successful treatment option for patients confronted with both partial and complete edentulism. Based on the literature, the survival rate of dental implants, which is defined that the dental implants are still in the mouth after insertion, is around 95% in the 5-year follow-up and around 90% in the 10-year follow-up. The success rate of dental implants, which is defined as dental implants in function, with good hard and soft tissue physiology and user satisfaction ranges from 85.2% to 88.7% in the follow-up of up to 20 years. This indicates that both the success rate and survival rate of dental implants is high. However, both survival rates and success rates vary across patients with different profiles. The expense of dental implant treatment is high and implant placement is a surgical procedure which is invasive and thus risky for the patients' health. Once the failure of dental implants occurs, it may cause some severe negative consequences for patients. For example, the failure will cause a financial loss for patients and a possible shock concerning both mental and physical aspects. To reduce these risks it is important and necessary for clinicians to be able to predict the risk of the failure of dental implants of individual patients before they undergo dental implant treatment.

Aim:

The aim of the project is to find out the possible risk factors for failure of dental implants and to develop a prediction model for the failure of dental implants at follow-up as a tool for clinicians to establish patients individual risk profile.

Methods:

The study is a retrospective design. The clinical data of the adult patients who were referred to the Department of Oral Implantology and Prosthetic Dentistry, Academic Centre for Dentistry Amsterdam (ACTA) for placement of dental implants from September 2009 to September 2013 are collected retrospectively from the clinical data management system of ACTA in the study.

The potential predictors include five domains: patients' demographic characteristics, lifestyle habits, general health, dental health, and implant characteristics. These predictors are pre-screened by international experts in dental implantology based their clinical knowledge and experience.

The outcomes included the follow-up time of implants and whether the failure of the implants was observed at the follow-up. The follow-up time is defined as the difference in time between implant placement and implant failure, or the date of the last follow-up time point if the dental implant is in an acceptable state. The failure of implants is defined as the presence of peri-implantitis, presence of mobility of implants, or removal of the implants for any reasons, for instance, unacceptable performance in aspects of function, tissue physiology, esthetics, and patients' satisfaction after placement of suprastructure.

The Multivariate Cox proportional hazards regression analysis will be used to find out the important risk factors and to develop the model. The performance of the model, in aspects of calibration and discrimination, is assessed. The clinical added values of the model is assessed. Then, the model is transformed into a score chart and a line chart, which is easy-to-use to the clinicians for the prediction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients were over 18 years old at baseline;
  • patients underwent the placement of at least one implant;
  • patients were followed up for the implants at least one time after placement of implants;
  • patients provided their informed consent.

Exclusion criteria

  • patients were <18 years old at baseline;
  • patients were not followed up;
  • patients did not provide the informed consent.

Treatment and study plan

placement of dental implants

Procedure

All the included patients underwent the placement of at least one implant in either upper jaw, or lower jaw, or both.

Other names: No other intervention

Primary outcomes

  1. Failure of dental implants

    Time frame: up to 5 years follow-up

    The failure of implants was defined as the presence of peri-implantitis, presence of mobility of implants, or removal of the implants for any reasons, for instance, unacceptable performance in aspects of function, tissue physiology, esthetics, and patients' satisfaction after placement of suprastructure.

  2. Follow-up time

    Time frame: up to 5 years follow-up

    The follow-up time is defined as the difference in time between implant placement and implant failure, or the date of the last follow-up time point if the dental implant is in an acceptable state.

Sponsors and collaborators

Lead sponsor

Academic Centre for Dentistry in Amsterdam

Other

Registry information

Official study title

The Prediction of Failure Rate of Dental Implants

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 17, 2019
Registry last updated
Oct 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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