Dental Implant FailedNCT04983758
20-year Implant Survival in Periodontally Healthy and Compromised Patients
An observational study of Dental Implant Failed and Peri-Implantitis, run by University of Turin, Italy at 1 site in Italy.
Trial summary
The aim of this study will be to compare the long-term outcomes of sandblasted and acid-etched (SLA) implants in patients previously treated for periodontitis and in periodontally healthy patients (PHP) after a follow-up of at least 20-years. 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, Bone Loss
- What is being tested?
- Oral Rehabilitation with dental implants
- Type of treatment
- Pill or oral medicine
- How many people
- 149 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2021to 1 Jul 2023
- 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: All patients attending the principle investigator (M.R.), a specialist in periodontology, for dental implant therapy between December 1998 and September 2001 were screened for possible inclusion in the study.
Who may be able to join
- complete edentulism;
- presence of an implant-supported overdenture;
- mucosal diseases;
- alcohol and drug abuse;
- pregnancy;
- uncontrolled metabolic disorders;
- aggressive periodontitis;
- no interest in participating in the study
Who cannot join
- Everything not as Inclusion Criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term (20-year) Implant Survival and Success Rates in Patients Healthy and Compromised Patients
The aim of this study will be to compare the long-term outcomes of sandblasted and acid-etched (SLA) implants in patients previously treated for periodontitis and in periodontally healthy patients (PHP) after a follow-up of at least 20-years.
- Conditions
- Dental Implant Failed, Peri-Implantitis, Bone Loss
- Being tested
- Oral Rehabilitation with dental implants
- Medical subject headings
- Peri-Implantitis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Rehabilitation with dental implantsOther
Patients have been treated with oral dental implants supporting fixed dental prostheses
| Study group | Role | What they receive |
|---|---|---|
| PHP | Not described Receives: Other: Oral Rehabilitation with dental implants | |
| Moderate PCP | Not described Receives: Other: Oral Rehabilitation with dental implants | |
| Severe PCP | Not described Receives: Other: Oral Rehabilitation with dental implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival rate
Change in percentage of dental implants in situ / dental implants placed
Measured: Baseline; 10-year at the 20-year follow-up examination
Secondary outcomes (1)
Marginal Bone loss
Changes in mm of the peri-implant marginal bone loss
Measured: Baseline; 10-year at the 20-year follow-up examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Jul 2023 (estimated)
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
- 149 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Roccuzzo, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983758
- Sponsor's protocol ID
- 168/2021
- Status last verified
- Jul 2021
- First submitted
- 6 Jul 2021
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term (20-year) Implant Survival and Success Rates in Patients Healthy and Compromised Patients
- ClinicalTrials.gov ID
- NCT04983758
- Acronym / sponsor ID
- 168/2021
- Conditions
- Dental Implant Failed, Peri-Implantitis, Bone Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 30 Jul 2021 (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 will be to compare the long-term outcomes of sandblasted and acid-etched (SLA) implants in patients previously treated for periodontitis and in periodontally healthy patients (PHP) after a follow-up of at least 20-years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PHP | – | Other: Oral Rehabilitation with dental implants |
| Moderate PCP | – | Other: Oral Rehabilitation with dental implants |
| Severe PCP | – | Other: Oral Rehabilitation with dental implants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients attending the principle investigator (M.R.), a specialist in periodontology, for dental implant therapy between December 1998 and September 2001 were screened for possible inclusion in the study.
Key inclusion criteria (8 listed)
- complete edentulism;
- presence of an implant-supported overdenture;
- mucosal diseases;
- alcohol and drug abuse;
- pregnancy;
Key exclusion criteria (1 listed)
- Everything not as Inclusion Criteria
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 |
|---|---|---|
| Oral Rehabilitation with dental implantsPatients have been treated with oral dental implants supporting fixed dental prostheses | Other | Moderate PCP, PHP, Severe PCP |
Primary outcome
Implant survival rate
Time frame: Baseline; 10-year at the 20-year follow-up examination
Change in percentage of dental implants in situ / dental implants placed
1 secondary outcome
Marginal Bone loss
Time frame: Baseline; 10-year at the 20-year follow-up examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- 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.
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 University of Turin, Italy at 1 site in Italy.
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 8 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: status not confirmed, as of the sponsor's last update on 30 Jul 2021. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mario Roccuzzo (+390117714732, mario.roccuzzo@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survival rate (time frame: Baseline; 10-year at the 20-year follow-up examination). 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 30 Jul 2021.