Dental Implant FailedNCT04270396
Early and Late Implant Failure
An observational study of Dental Implant Failed and Peri-Implantitis, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
The aim of this study was to evaluate the early and late implant loss rate in a sample of patients who had received implant-supportive restorative therapy in a university setting. Moreover, the study aimed to identify patient- and implant-related variables for implant failure 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 Failed, Peri-Implantitis
- What is being tested?
- Presence or absence of implant
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 190 participants
- Where
- 1 siteSpain
- Study dates
- 5 Oct 2017to 24 Apr 2019
- How long will I take part?
- 1 Day
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: A sample of men and women over 18 years old, which they had received an implant-supportive restorative therapy in a university setting throughout a period of at least 7 years.
Who may be able to join
- Men and women over 18 years old
- Partially or totally edentulous patients with at least one implant placed at the university and at least 7 years before.
- Cemented, screwed, or mechanically retained prosthesis.
- Single and partial prostheses, as well as complete arch prosthesis (fixed and removable).
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implant Failure and Risk Indicators
The aim of this study was to evaluate the early and late implant loss rate in a sample of patients who had received implant-supportive restorative therapy in a university setting. Moreover, the study aimed to identify patient- and implant-related variables for implant failure
- Conditions
- Dental Implant Failed, Peri-Implantitis
- Being tested
- Presence or absence of implant
- Keywords
- dental implant survival, implant failure, early implant failure, late implant failure
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presence or absence of implantBehavioural
We procedure to observed clinically the sample size, to be able to determine if the dental implant was present or no. If the implant was absent we recorded if it was early( prior to restoration) or late ( after prosthesis was delivered).
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival
Early implant loss and late implant loss
Measured: October 2017 to March 2019
Secondary outcomes (1)
Implant failure
biological and mechanical complications
Measured: October 2017 to March 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start5 Oct 2017
- Primary completion14 Mar 2019
- Study completion24 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies 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
- Prospective
- Enrolment
- 190 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Takamoli, Universitat Internacional de Catalunya
- Investigators
- Joan Takamoli, Principal investigator, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270396
- Sponsor's protocol ID
- PER-ECL-2017-04
- Status last verified
- Feb 2020
- First submitted
- 12 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant Failure and Risk Indicators
- ClinicalTrials.gov ID
- NCT04270396
- Acronym / sponsor ID
- PER-ECL-2017-04
- Conditions
- Dental Implant Failed, Peri-Implantitis
- Keywords
- dental implant survival, implant failure, early implant failure, late implant failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 14 Mar 2019 (actual)
- Study completion
- 24 Apr 2019 (actual)
- First posted
- 17 Feb 2020 (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 this study was to evaluate the early and late implant loss rate in a sample of patients who had received implant-supportive restorative therapy in a university setting. Moreover, the study aimed to identify patient- and implant-related variables for implant failure
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A sample of men and women over 18 years old, which they had received an implant-supportive restorative therapy in a university setting throughout a period of at least 7 years.
Key inclusion criteria (4 listed)
- Men and women over 18 years old
- Partially or totally edentulous patients with at least one implant placed at the university and at least 7 years before.
- Cemented, screwed, or mechanically retained prosthesis.
- Single and partial prostheses, as well as complete arch prosthesis (fixed and removable).
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Presence or absence of implantWe procedure to observed clinically the sample size, to be able to determine if the dental implant was present or no. If the implant was absent we recorded if it was early( prior to restoration) or late ( after prosthesis was delivered). | Behavioural | – |
Primary outcome
Implant survival
Time frame: October 2017 to March 2019
Early implant loss and late implant loss
1 secondary outcome
Implant failure
Time frame: October 2017 to March 2019
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 17 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
Joan Takamoli principal investigator
Universitat Internacional de Catalunya
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 Failed and Peri-Implantitis, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 1 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 17 Feb 2020. 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 Spain. 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?
Implant survival (time frame: October 2017 to March 2019). 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 17 Feb 2020.