Dental Implant FailureNCT02369562
A Retrospective Analysis of Failures of Oral Implants
An observational study of Dental Implant Failure and Periodontal Bone Loss, run by Malmö University at 1 site in Sweden.
Trial summary
The purpose of this retrospective study 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?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failure, Periodontal Bone Loss
- What is being tested?
- Evaluation of the failure rate of dental implants
- Type of treatment
- Surgery or procedure
- How many people
- 2,670 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2014to Sep 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The population rehabilitated with dental implants at/or referred to prosthetic rehabilitation at the Avdelning för Oral Protetik at the Folktandvården Specialistklinik in Malmö.
Who may be able to join
- All treated patients with dental implants placed and restored at the Avdelning för Oral Protetik at the Folktandvården Specialistklinik in Malmö with an available dental record;
- Patients having read, understood, and signed the Form for Patient Information and the Informed Consent.
Who cannot join
- Patients not willing to give their permission to scrutinize their records;
- Lack of enough data in the patients' dental records.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Analysis of Failures/Complications With Oral Implants
The purpose of this retrospective study 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
This is a retrospective study that involves collecting information about the past and comparing that with contemporary information collected from the same cases. The patients' dental records' archive and the digital dental records of the Folktandvården Specialistklinik in Malmö will be scrutinized. The patients will be retraced in the Swedish Personal Data System and will be invited for a recall visit with a clinical and radiographic examination. 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. In case the patient is not willing to pay a recall visit, only the data of the patient's records will be used, under the patients' approval.
The data from the patients' records will be directly inserted to a computer file of the statistical software Statistical Package for the Social Sciences (SPSS Inc., Chicago, USA). The additional follow-up information from the patients' recall visit will be collected in specific forms and then inserted to the previously mentioned computer file. All dental implants inserted will be included in the study. Data will be categorized as surgical, implant-specific, patient-related, anatomic, loading conditions, prosthetic, and trans- and postoperative complications.
Periapical radiographies of the patients' digital record will be neatly filed in a computer file. Periapical radiographies that could possibly exist in celluloid film will be digitalized. From each patient, additional radiographs will be selected from the patient's record, based on availability in several time intervals. At the recall consultation, new periapical radiographies will be taken. The reference point will be established at the implants-abutment junction, and the marginal bone level measurement will be performed by using the Image J software.
- Conditions
- Dental Implant Failure, Periodontal Bone Loss
- Being tested
- Evaluation of the failure rate of dental implants
- Keywords
- Dental implants, Periodontal Bone Loss
- 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.
Evaluation of the failure rate of dental implantsProcedure or surgery
Also called Implant failure rate assessment
Evaluation of the failure rate of dental implants, from the time of implant insertion (any time between 1980 and August 31st 2014) until September 2015
| Study group | Role | What they receive |
|---|---|---|
| Dental implant patients | All patients rehabilitated with dental implants. Receives: Procedure: Evaluation of the failure rate 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 or until its failure
Measured: Including implants placed from 1980 until August 31st 2014
Secondary outcomes (1)
Marginal bone loss
Time from the surgical placement of implants until the last follow-up
Measured: Including implants placed from 1980 until August 31st 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,670 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 director, Malmö UniversityTomas Albrektsson, MD PhD, Study director, Göteborg University / Malmö UniversityJenö Kisch, DDS, Study chair, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369562
- Sponsor's protocol ID
- Dnr 2014/598
- Status last verified
- Oct 2023
- First submitted
- 10 Feb 2015
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chrcanovic BR, Kisch J, Albrektsson T, Wennerberg A. Factors Influencing Early Dental Implant Failures. J Dent Res. 2016 Aug;95(9):995-1002. doi: 10.1177/0022034516646098. Epub 2016 May 4.
PubMed 27146701
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis of Failures/Complications With Oral Implants
- ClinicalTrials.gov ID
- NCT02369562
- Acronym / sponsor ID
- Dnr 2014/598
- Conditions
- Dental Implant Failure, Periodontal Bone Loss
- Keywords
- Dental implants, Periodontal Bone Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,670 participants (actual)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Collaborators
- Region Skane
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 24 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 retrospective study 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
This is a retrospective study that involves collecting information about the past and comparing that with contemporary information collected from the same cases. The patients' dental records' archive and the digital dental records of the Folktandvården Specialistklinik in Malmö will be scrutinized. The patients will be retraced in the Swedish Personal Data System and will be invited for a recall visit with a clinical and radiographic examination. 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. In case the patient is not willing to pay a recall visit, only the data of the patient's records will be used, under the patients' approval.
The data from the patients' records will be directly inserted to a computer file of the statistical software Statistical Package for the Social Sciences (SPSS Inc., Chicago, USA). The additional follow-up information from the patients' recall visit will be collected in specific forms and then inserted to the previously mentioned computer file. All dental implants inserted will be included in the study. Data will be categorized as surgical, implant-specific, patient-related, anatomic, loading conditions, prosthetic, and trans- and postoperative complications.
Periapical radiographies of the patients' digital record will be neatly filed in a computer file. Periapical radiographies that could possibly exist in celluloid film will be digitalized. From each patient, additional radiographs will be selected from the patient's record, based on availability in several time intervals. At the recall consultation, new periapical radiographies will be taken. The reference point will be established at the implants-abutment junction, and the marginal bone level measurement will be performed by using the Image J software.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental implant patients | – | Procedure: Evaluation of the failure rate of dental implantsAll patients rehabilitated with dental implants. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population rehabilitated with dental implants at/or referred to prosthetic rehabilitation at the Avdelning för Oral Protetik at the Folktandvården Specialistklinik in Malmö.
Key inclusion criteria (2 listed)
- All treated patients with dental implants placed and restored at the Avdelning för Oral Protetik at the Folktandvården Specialistklinik in Malmö with an available dental record;
- Patients having read, understood, and signed the Form for Patient Information and the Informed Consent.
Key exclusion criteria (2 listed)
- Patients not willing to give their permission to scrutinize their records;
- Lack of enough data in the patients' dental records.
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 |
|---|---|---|
| Evaluation of the failure rate of dental implantsAlso: Implant failure rate assessmentEvaluation of the failure rate of dental implants, from the time of implant insertion (any time between 1980 and August 31st 2014) until September 2015 | Procedure or surgery | Dental implant patients |
Primary outcome
Survival of implants
Time frame: Including implants placed from 1980 until August 31st 2014
Time from the surgical placement of implants until the last follow-up or until its failure
1 secondary outcome
Marginal bone loss
Time frame: Including implants placed from 1980 until August 31st 2014
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 19 Oct 2023.
- Derived from this study: PubMed 27146701Chrcanovic BR, Kisch J, Albrektsson T, Wennerberg A. Factors Influencing Early Dental Implant Failures. J Dent Res. 2016 Aug;95(9):995-1002. doi: 10.1177/0022034516646098. Epub 2016 May 4.
- Individual participant dataSharing planned: No
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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 director
Malmö University
Tomas Albrektsson, MD PhD study director
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?
An observational study of 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 2 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 19 Oct 2023. 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: Including implants placed from 1980 until August 31st 2014). 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 NCT02369562, which also lists 1 linked publication.
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 19 Oct 2023.