Clinical trial NCT04129957: Prediction of Failure of Dental Implants
Official title: The Prediction of Failure Rate of Dental Implants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Implant Complication
Peri-Implantitis
Keywords: prediction
dental implants
failure
peri-implantitis
Lead sponsor: Academic Centre for Dentistry in Amsterdam
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The included patients were those who were referred to the Department of Oral Implantology and Prosthetic Dentistry, ACTA for placement of implant(s).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Failure of dental implants
timeFrame: up to 5 years follow-up
measure: Follow-up time
timeFrame: up to 5 years follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Centre for Dentistry in Amsterdam
state: Noord-Holland
Study officials:
affiliation: Academic Centre for Dentistry Amsterdam
name: Geert van der Heijden, Prof. dr.
role: STUDY_CHAIR
References:
citation: Pjetursson BE, Thoma D, Jung R, Zwahlen M, Zembic A. A systematic review of the survival and complication rates of implant-supported fixed dental prostheses (FDPs) after a mean observation period of at least 5 years. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:22-38. doi: 10.1111/j.1600-0501.2012.02546.x.
citation: Pjetursson BE, Asgeirsson AG, Zwahlen M, Sailer I. Improvements in implant dentistry over the last decade: comparison of survival and complication rates in older and newer publications. Int J Oral Maxillofac Implants. 2014;29 Suppl:308-24. doi: 10.11607/jomi.2014suppl.g5.2.
citation: Jung RE, Zembic A, Pjetursson BE, Zwahlen M, Thoma DS. Systematic review of the survival rate and the incidence of biological, technical, and aesthetic complications of single crowns on implants reported in longitudinal studies with a mean follow-up of 5 years. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:2-21. doi: 10.1111/j.1600-0501.2012.02547.x.
citation: Krebs M, Schmenger K, Neumann K, Weigl P, Moser W, Nentwig GH. Long-term evaluation of ANKYLOS(R) dental implants, part i: 20-year life table analysis of a longitudinal study of more than 12,500 implants. Clin Implant Dent Relat Res. 2015 Jan;17 Suppl 1:e275-86. doi: 10.1111/cid.12154. Epub 2013 Sep 17.
citation: Lekholm U, Grondahl K, Jemt T. Outcome of oral implant treatment in partially edentulous jaws followed 20 years in clinical function. Clin Implant Dent Relat Res. 2006;8(4):178-86. doi: 10.1111/j.1708-8208.2006.00019.x.
citation: Ostman PO, Hellman M, Sennerby L. Ten years later. Results from a prospective single-centre clinical study on 121 oxidized (TiUnite) Branemark implants in 46 patients. Clin Implant Dent Relat Res. 2012 Dec;14(6):852-60. doi: 10.1111/j.1708-8208.2012.00453.x. Epub 2012 May 29.