Implant ComplicationNCT04129957
Prediction of Failure of Dental Implants
An observational study of Implant Complication and Peri-Implantitis, run by Academic Centre for Dentistry in Amsterdam at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implant Complication, Peri-Implantitis
- What is being tested?
- Placement of dental implants
- Type of treatment
- Surgery or procedure
- How many people
- 337 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Dec 2018to 15 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- patients were <18 years old at baseline;
- patients were not followed up;
- patients did not provide the informed consent.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Centre for Dentistry in Amsterdam
Amsterdam, North Holland, 1081LA
About this study
Official title: The Prediction of Failure Rate 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.
Read the 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.
- Conditions
- Implant Complication, Peri-Implantitis
- Being tested
- Placement of dental implants
- Keywords
- prediction, dental implants, failure, peri-implantitis
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of dental implantsProcedure or surgery
Also called No other intervention
All the included patients underwent the placement of at least one implant in either upper jaw, or lower jaw, or both.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Placement of dental implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start10 Dec 2018
- Primary completion30 Jun 2019
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Implant ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academic Centre for Dentistry in Amsterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naichuan Su, Academic Centre for Dentistry in Amsterdam
- Investigators
- Geert van der Heijden, Prof. dr., Study chair, Academic Centre for Dentistry Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129957
- Sponsor's protocol ID
- 2018.376
- Status last verified
- Oct 2019
- First submitted
- 15 Oct 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The participants' clinical data and data on demographic characteristics are possible to be shared. But those data can be only used for research purpose.
Publications
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.
PubMed 23062125Pjetursson 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.
PubMed 24660206Jung 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.
PubMed 23062124Krebs 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.
PubMed 24103113Lekholm 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.
PubMed 17100743Ostman 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.
PubMed 22642261
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prediction of Failure Rate of Dental Implants
- ClinicalTrials.gov ID
- NCT04129957
- Acronym / sponsor ID
- 2018.376
- Conditions
- Implant Complication, Peri-Implantitis
- Keywords
- prediction, dental implants, failure, peri-implantitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Academic Centre for Dentistry in AmsterdamUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent placement of dental implants | – | Procedure: Placement of dental implantsThe study only includes one cohort. That is the patients who underwent placement of dental implants at baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- patients were <18 years old at baseline;
- patients were not followed up;
- patients did not provide the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placement of dental implantsAlso: No other interventionAll the included patients underwent the placement of at least one implant in either upper jaw, or lower jaw, or both. | Procedure or surgery | Patients who underwent placement of dental implants |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Background: PubMed 23062125Pjetursson 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.
- Background: PubMed 24660206Pjetursson 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.
- Background: PubMed 23062124Jung 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.
- Background: PubMed 24103113Krebs 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.
- Background: PubMed 17100743Lekholm 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.
- Background: PubMed 22642261Ostman 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.
- Individual participant dataSharing planned: Yes. The participants' clinical data and data on demographic characteristics are possible to be shared. But those data can be only used for research purpose.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geert van der Heijden, Prof. dr. study chair
Academic Centre for Dentistry Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implant Complication and Peri-Implantitis, run by Academic Centre for Dentistry in Amsterdam at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of dental implants (time frame: up to 5 years follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04129957, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.