NCT04129957

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
337

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

October 15, 2019

Last Update Submit

October 17, 2019

Conditions

Keywords

predictiondental implantsfailureperi-implantitis

Outcome Measures

Primary Outcomes (2)

  • Failure of dental implants

    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.

    up to 5 years follow-up

  • Follow-up time

    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.

    up to 5 years follow-up

Study Arms (1)

Patients who underwent placement of dental implants

The study only includes one cohort. That is the patients who underwent placement of dental implants at baseline.

Procedure: Placement of dental implants

Interventions

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

Also known as: No other intervention
Patients who underwent placement of dental implants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Centre for Dentistry in Amsterdam

Amsterdam, North Holland, 1081LA, Netherlands

Location

Related Publications (6)

  • 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.

    PMID: 23062125BACKGROUND
  • 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.

    PMID: 24660206BACKGROUND
  • 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.

    PMID: 23062124BACKGROUND
  • 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.

    PMID: 24103113BACKGROUND
  • 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.

    PMID: 17100743BACKGROUND
  • 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.

    PMID: 22642261BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Geert van der Heijden, Prof. dr.

    Academic Centre for Dentistry Amsterdam

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2019

First Posted

October 17, 2019

Study Start

December 10, 2018

Primary Completion

June 30, 2019

Study Completion

August 15, 2019

Last Updated

October 21, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will share

The participants' clinical data and data on demographic characteristics are possible to be shared. But those data can be only used for research purpose.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Starting 6 months after the publication. The data will be available for 15 years after the end of the study.
Access Criteria
The data can be shared upon researchers' request via email (n.su@acta.nl). Naichuan Su will review the requests. The researchers need to share their protocols and guarantee that the data is only used for research purpose.

Locations