Pocket DepthNCT06803576
Clinical and Microbiological Outcomes of Dental Implants After 10-22 Years of Function
An observational study of Pocket Depth and Attachment Loss, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Aim: the aim of this retrospective study is to present long-term data (10+ years of functional loading) on the success and survival of ZimVie (3i) implants. Data from a patient pool of a private periodontal office will be used to reexamine patients with at least 10 years of loading of their dental implants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pocket Depth, Attachment Loss, Bone Loss in Jaw
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2025to 30 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 patient sample of this study is part of a retrospective evaluation of patients who received treatment with dental implants in a private periodontal practice run by a single specialist Periodontist (A.B.) between 2000 and 2013, with at least 10 years of functional loading of their prosthetic work. A comprehensive chart review revealed 208 potential patients, and an effort will be made to invite all of them for a reevaluation appointment.
Who may be able to join
- Age 18 years and over
- Systemic health or controlled medical conditions
- Periodontal health, either no periodontal disease, or previously treated periodontal disease under a supportive periodontal maintenance (SPT) program
- Smokers were included but encouraged to enter a smoking cessation program
- Patients with bruxism or parafunctional habits were included.
Who cannot join
- Uncontrolled medical conditions
- Active uncontrolled periodontal disease
- Inability to present for the reevaluation appointment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical and Microbiological Parameters of Success Following the Application of Osseointegrated Dental Implants. A 10-year Retrospective Study
Aim: the aim of this retrospective study is to present long-term data (10+ years of functional loading) on the success and survival of ZimVie (3i) implants. Data from a patient pool of a private periodontal office will be used to reexamine patients with at least 10 years of loading of their dental implants.
Parameters to be examined are bone loss, biologic and prosthetic complications, as well as Patient Reported Outcomes (PROMs) to analyze patient satisfaction with dental implant treatment
Read the detailed description
Aim: the aim of this study is to present long-term data (10+ years of functional loading) on the success and survival of ZimVie (3i) implants.
Clinical relevance: The successful application of dental implants in replacing missing teeth has been proven since the late 1980's. Over the years a great number of changes in implant designs and implant companies have entered in the dental field of practice. One of the most important questions that have to be addressed is the long-term stability and success of dental implants. While some implant brands have shown reliable long-term stability of their implants, there is still a lack of long-term studies (over 10 years of functional loading) for many implant systems, as it is quite hard to follow-up on patients for such a long time. Therefore, long-term data on implant survival and success is particurarly useful, especially if it is based on private practice patient, thus reflecting the aspects of everyday practice of implantology
Materials and methods: A comprehensive search of patient records from the private practice of the primary investigator (A.B.) was conducted and patients that received dental implant placement from 2001 until 2013 will be asked to participate in the study. After signing the relevant consent forms, all patients that are willing to participate in the study will be examined clinically and radiographically. The following parameters will be examined:
- Age, sex of patient
- Relevant medical history
- Smoking history
- Compliance to recall appointments
- Early implant losses
- Years of prosthetic loading of implants
- Implant characteristics (length, diameter, surface, cylindrical or root-shaped)
- Type of prosthesis (single or multiple abutments, cemented or screw-retained)
- Biological complications (mucositis, peri-implantitis)
- Prosthetic complications (minor, moderate or severe)
- History of periodontal disease and treatment prior or after implant placement
- Prosthetic work performed by specialist or general practitioner
- Maintenance performed by specialist or general practitioner
- Relevant ridge augmentation procedures during or before implant placement
- Clinical measurements (Pocket depth, Attachment loss, Bleeding on probing, presence of Plaque) on six site for every implant (MB, B, DB, ML, L, DL)
- Samples of the peri-implant sulcular fluid will taken with paper points and measured with Elisa kits to calculate the presence of the following biomarkers: RANKL, OPG, Il-a and TNF-b
- A radiograph will be taken with the parallel cone technique and compared to baseline xrays after implant placement to measure bone stability
- A questionnaire will be also provided to all study participants to measure satisfaction following implant therapy Data analysis The main parameter to be examined will be bone loss around an implant over time, as that relates to the definitions of peri-implant mucositis and peri-implantitis. Secondary outcomes will also be examined as pertaining to clinical differences according to the variety of 3i implants that have been used. External vs. internal hex, root-shape vs cylindrical, osseotite vs full osseotite vs nanotite surfaces etc. An number of around 100 patients are expected to be examined for a total of 250 implants.
- Conditions
- Pocket Depth, Attachment Loss, Bone Loss in Jaw
- Keywords
- dental implants, biologic complications, biomet 3i, Long-term results, prosthetic complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a least 10 years of loaded implants | Patients from a private periodontal office who have functioning implants for at least 10 years (range 10-22 years) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Marginal Bone loss
The amount of vertical bone loss around the mesial and distal surface of an implant, when bone levels at time of placement and at reevaluation were compared
Measured: 10-22 years
Secondary outcomes (2)
Implant Survival and Success Rates
Implant Survival Rate was defined as an implant still in place at the time of reevaluation and Implant Success Rate was defined as an implant with marginal bone loss up to 2 mm
Measured: 10-22 years
Incidence of peri-implant pathology
The percentages of implants that are healthy, have peri-implant mucositis or peri-implantitis
Measured: 10-22 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Jan 2025
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pocket DepthStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis Vouros, Aristotle University Of Thessaloniki
- Investigators
- Ioannis Vouros, DDS PHD, Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803576
- Sponsor's protocol ID
- 458/16-4-2021
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: there is a plan to make IPD available. It also means that a data dictionary (a description of the variables, or types of data, collected for each individual) will be provided so that the data can be fully interpreted.
Publications
Amelie Bäumer1,2*, Shirin Toekan3, Daniel Saure4 and Gerd Körner2
Carra MC, Blanc-Sylvestre N, Courtet A, Bouchard P. Primordial and primary prevention of peri-implant diseases: A systematic review and meta-analysis. J Clin Periodontol. 2023 Jun;50 Suppl 26:77-112. doi: 10.1111/jcpe.13790. Epub 2023 Mar 6.
PubMed 36807599Chappuis V, Buser R, Bragger U, Bornstein MM, Salvi GE, Buser D. Long-term outcomes of dental implants with a titanium plasma-sprayed surface: a 20-year prospective case series study in partially edentulous patients. Clin Implant Dent Relat Res. 2013 Dec;15(6):780-90. doi: 10.1111/cid.12056. Epub 2013 Mar 18.
PubMed 23506385Frisch E, Vach K, Ratka-Krueger P. Impact of supportive implant therapy on peri-implant diseases: A retrospective 7-year study. J Clin Periodontol. 2020 Jan;47(1):101-109. doi: 10.1111/jcpe.13206. Epub 2019 Nov 6.
PubMed 31599464
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Parameters of Success Following the Application of Osseointegrated Dental Implants. A 10-year Retrospective Study
- ClinicalTrials.gov ID
- NCT06803576
- Acronym / sponsor ID
- 458/16-4-2021
- Conditions
- Pocket Depth, Attachment Loss, Bone Loss in Jaw
- Keywords
- dental implants, biologic complications, biomet 3i, Long-term results, prosthetic complications
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 31 Jan 2025 (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.
Aim: the aim of this retrospective study is to present long-term data (10+ years of functional loading) on the success and survival of ZimVie (3i) implants. Data from a patient pool of a private periodontal office will be used to reexamine patients with at least 10 years of loading of their dental implants.
Parameters to be examined are bone loss, biologic and prosthetic complications, as well as Patient Reported Outcomes (PROMs) to analyze patient satisfaction with dental implant treatment
Detailed description
Aim: the aim of this study is to present long-term data (10+ years of functional loading) on the success and survival of ZimVie (3i) implants.
Clinical relevance: The successful application of dental implants in replacing missing teeth has been proven since the late 1980's. Over the years a great number of changes in implant designs and implant companies have entered in the dental field of practice. One of the most important questions that have to be addressed is the long-term stability and success of dental implants. While some implant brands have shown reliable long-term stability of their implants, there is still a lack of long-term studies (over 10 years of functional loading) for many implant systems, as it is quite hard to follow-up on patients for such a long time. Therefore, long-term data on implant survival and success is particurarly useful, especially if it is based on private practice patient, thus reflecting the aspects of everyday practice of implantology
Materials and methods: A comprehensive search of patient records from the private practice of the primary investigator (A.B.) was conducted and patients that received dental implant placement from 2001 until 2013 will be asked to participate in the study. After signing the relevant consent forms, all patients that are willing to participate in the study will be examined clinically and radiographically. The following parameters will be examined:
- Age, sex of patient
- Relevant medical history
- Smoking history
- Compliance to recall appointments
- Early implant losses
- Years of prosthetic loading of implants
- Implant characteristics (length, diameter, surface, cylindrical or root-shaped)
- Type of prosthesis (single or multiple abutments, cemented or screw-retained)
- Biological complications (mucositis, peri-implantitis)
- Prosthetic complications (minor, moderate or severe)
- History of periodontal disease and treatment prior or after implant placement
- Prosthetic work performed by specialist or general practitioner
- Maintenance performed by specialist or general practitioner
- Relevant ridge augmentation procedures during or before implant placement
- Clinical measurements (Pocket depth, Attachment loss, Bleeding on probing, presence of Plaque) on six site for every implant (MB, B, DB, ML, L, DL)
- Samples of the peri-implant sulcular fluid will taken with paper points and measured with Elisa kits to calculate the presence of the following biomarkers: RANKL, OPG, Il-a and TNF-b
- A radiograph will be taken with the parallel cone technique and compared to baseline xrays after implant placement to measure bone stability
- A questionnaire will be also provided to all study participants to measure satisfaction following implant therapy Data analysis The main parameter to be examined will be bone loss around an implant over time, as that relates to the definitions of peri-implant mucositis and peri-implantitis. Secondary outcomes will also be examined as pertaining to clinical differences according to the variety of 3i implants that have been used. External vs. internal hex, root-shape vs cylindrical, osseotite vs full osseotite vs nanotite surfaces etc. An number of around 100 patients are expected to be examined for a total of 250 implants.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a least 10 years of loaded implants | – | –Patients from a private periodontal office who have functioning implants for at least 10 years (range 10-22 years) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient sample of this study is part of a retrospective evaluation of patients who received treatment with dental implants in a private periodontal practice run by a single specialist Periodontist (A.B.) between 2000 and 2013, with at least 10 years of functional loading of their prosthetic work. A comprehensive chart review revealed 208 potential patients, and an effort will be made to invite all of them for a reevaluation appointment.
Key inclusion criteria (5 listed)
- Age 18 years and over
- Systemic health or controlled medical conditions
- Periodontal health, either no periodontal disease, or previously treated periodontal disease under a supportive periodontal maintenance (SPT) program
- Smokers were included but encouraged to enter a smoking cessation program
- Patients with bruxism or parafunctional habits were included.
Key exclusion criteria (3 listed)
- Uncontrolled medical conditions
- Active uncontrolled periodontal disease
- Inability to present for the reevaluation appointment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Radiographic Marginal Bone loss
Time frame: 10-22 years
The amount of vertical bone loss around the mesial and distal surface of an implant, when bone levels at time of placement and at reevaluation were compared
2 secondary outcomes
Implant Survival and Success Rates
Time frame: 10-22 years
Incidence of peri-implant pathology
Time frame: 10-22 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- BackgroundAmelie Bäumer1,2*, Shirin Toekan3, Daniel Saure4 and Gerd Körner2
- Background: PubMed 36807599Carra MC, Blanc-Sylvestre N, Courtet A, Bouchard P. Primordial and primary prevention of peri-implant diseases: A systematic review and meta-analysis. J Clin Periodontol. 2023 Jun;50 Suppl 26:77-112. doi: 10.1111/jcpe.13790. Epub 2023 Mar 6.
- Background: PubMed 23506385Chappuis V, Buser R, Bragger U, Bornstein MM, Salvi GE, Buser D. Long-term outcomes of dental implants with a titanium plasma-sprayed surface: a 20-year prospective case series study in partially edentulous patients. Clin Implant Dent Relat Res. 2013 Dec;15(6):780-90. doi: 10.1111/cid.12056. Epub 2013 Mar 18.
- Background: PubMed 31599464Frisch E, Vach K, Ratka-Krueger P. Impact of supportive implant therapy on peri-implant diseases: A retrospective 7-year study. J Clin Periodontol. 2020 Jan;47(1):101-109. doi: 10.1111/jcpe.13206. Epub 2019 Nov 6.
- Individual participant dataSharing planned: Yes. there is a plan to make IPD available. It also means that a data dictionary (a description of the variables, or types of data, collected for each individual) will be provided so that the data can be fully interpreted.
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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.
Ioannis Vouros, DDS PHD principal investigator
Aristotle University Of Thessaloniki
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 Pocket Depth and Attachment Loss, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 5 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: enrolling by invitation, as of the sponsor's last update on 4 Feb 2025. 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 Greece. 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?
This study is still under way. Results are not available in the source record yet.
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?
Radiographic Marginal Bone loss (time frame: 10-22 years). 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 NCT06803576, which also lists 4 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 4 Feb 2025.