Dental Implant FailureNCT02374216
A Prospective Analysis of Failures of Oral Implants
A study testing Insertion of dental implants in people with Dental Implant Failure and Periodontal Bone Loss, run by Malmö University at 1 site in Sweden.
Trial summary
The purpose of this prospective clinical trial is to investigate and identify factors associated with the failure of dental implants within the population rehabilitated with dental implants at the Folktandvården Specialistklinik in Malmö (Spårvägsgatan 12, 214 27, Malmö). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failure, Periodontal Bone Loss
- What is being tested?
- Insertion of dental implants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2014to Aug 2018
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with a minimum age of 18 years;
- Patients having read, understood, and signed the Form for Patient Information and the Informed Consent.
Who cannot join
- Age less than 18 years;
- General contraindications for implant surgery;
- Subjects with an untreated systemic disease. A complete medical report will permit the disqualification of subjects with an untreated systemic disease. Patients with a systemic disease such as diabetes or hypertension will not be excluded, as long as these pathologies were treated and stabilized within normal biologic parameters.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Analysis of Failures/Complications With Oral Implants
The purpose of this prospective clinical trial is to investigate and identify factors associated with the failure of dental implants within the population rehabilitated with dental implants at the Folktandvården Specialistklinik in Malmö (Spårvägsgatan 12, 214 27, Malmö).
Read the detailed description
The treatment begins with screening against inclusion and exclusion criteria. The patients will then be informed of the design of the study through the reading of the Form for Patient Information and the Informed Consent in Swedish and verbally.
All dental implants to be inserted will be included in the study. Some surgical, implant, loading, prosthetic variables of the study will be decided according to the surgeon's criteria and patient's decisions.
Data will be collected in specific forms, and will be categorized as surgical, implant-specific, patient-related, anatomic, loading conditions, prosthetic, and complications.
Besides descriptive statistics, Kaplan-Meier analysis will be used to estimate implant survival/failure rates (an estimator for estimating the survival function from lifetime data), and multivariate Cox proportional hazards models will be used to identify prognostic variables.
- Conditions
- Dental Implant Failure, Periodontal Bone Loss
- Being tested
- Insertion of dental implants
- Keywords
- Dental Implants, Periodontal Bone Loss, Implant-Supported Dental Prosthesis, Dental Prosthesis Failure
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of dental implantsProcedure or surgery
Also called Dental implant surgical placement
Evaluation of the failure rate of all dental implants, of any brand, inserted between September 1st 2014 to August 31st 2017
| Study group | Role | What they receive |
|---|---|---|
| Dental implants | Other | Evaluation of the failure rate of all dental implants, of any brand, inserted between September 1st 2014 and August 31st 2017 Receives: Procedure: Insertion of dental implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of implants
Time from the surgical placement of implants until the last follow-up visit or until its failure
Measured: Up to 3 years
Secondary outcomes (2)
Marginal bone loss
Time from the surgical placement of implants until the last follow-up visit
Measured: Up to 3 years
Dental prosthesis complications
Time from the surgical placement of implants until the last follow-up visit
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startSep 2014
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Skane
- Responsible party
- Principal investigator, Bruno Ramos Chrcanovic, Malmö University
- Investigators
- Bruno R Chrcanovic, DDS MSc, Principal investigator, Malmö UniversityAnn Wennerberg, DDS PhD, Study chair, Malmö UniversityTomas Albrektsson, MD PhD, Study chair, Göteborg University / Malmö UniversityJenö Kisch, DDS, Study director, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374216
- Sponsor's protocol ID
- Dnr 2014/333
- Status last verified
- Mar 2019
- First submitted
- 10 Feb 2015
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Analysis of Failures/Complications With Oral Implants
- ClinicalTrials.gov ID
- NCT02374216
- Acronym / sponsor ID
- Dnr 2014/333
- Conditions
- Dental Implant Failure, Periodontal Bone Loss
- Keywords
- Dental Implants, Periodontal Bone Loss, Implant-Supported Dental Prosthesis, Dental Prosthesis Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Collaborators
- Region Skane
- Study start
- Sep 2014
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 27 Feb 2015 (estimated)
- 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 purpose of this prospective clinical trial is to investigate and identify factors associated with the failure of dental implants within the population rehabilitated with dental implants at the Folktandvården Specialistklinik in Malmö (Spårvägsgatan 12, 214 27, Malmö).
Detailed description
The treatment begins with screening against inclusion and exclusion criteria. The patients will then be informed of the design of the study through the reading of the Form for Patient Information and the Informed Consent in Swedish and verbally.
All dental implants to be inserted will be included in the study. Some surgical, implant, loading, prosthetic variables of the study will be decided according to the surgeon's criteria and patient's decisions.
Data will be collected in specific forms, and will be categorized as surgical, implant-specific, patient-related, anatomic, loading conditions, prosthetic, and complications.
Besides descriptive statistics, Kaplan-Meier analysis will be used to estimate implant survival/failure rates (an estimator for estimating the survival function from lifetime data), and multivariate Cox proportional hazards models will be used to identify prognostic variables.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental implants | Other | Procedure: Insertion of dental implantsEvaluation of the failure rate of all dental implants, of any brand, inserted between September 1st 2014 and August 31st 2017 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a minimum age of 18 years;
- Patients having read, understood, and signed the Form for Patient Information and the Informed Consent.
Key exclusion criteria (3 listed)
- Age less than 18 years;
- General contraindications for implant surgery;
- Subjects with an untreated systemic disease. A complete medical report will permit the disqualification of subjects with an untreated systemic disease. Patients with a systemic disease such as diabetes or hypertension will not be excluded, as long as these pathologies were treated and stabilized within normal biologic parameters.
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 |
|---|---|---|
| Insertion of dental implantsAlso: Dental implant surgical placementEvaluation of the failure rate of all dental implants, of any brand, inserted between September 1st 2014 to August 31st 2017 | Procedure or surgery | Dental implants |
Primary outcome
Survival of implants
Time frame: Up to 3 years
Time from the surgical placement of implants until the last follow-up visit or until its failure
2 secondary outcomes
Marginal bone loss
Time frame: Up to 3 years
Dental prosthesis complications
Time frame: Up to 3 years
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 7 Mar 2019.
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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.
Bruno R Chrcanovic, DDS MSc principal investigator
Malmö University
Ann Wennerberg, DDS PhD study chair
Malmö University
Tomas Albrektsson, MD PhD study chair
Göteborg University / Malmö University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insertion of dental implants in people with Dental Implant Failure and Periodontal Bone Loss, run by Malmö University at 1 site in Sweden.
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 2 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 7 Mar 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 Sweden. 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?
Survival of implants (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2019.