Clinical and Microbiological Outcomes of Dental Implants After 10-22 Years of Function

January 31, 2025 updated by: Ioannis Vouros, Aristotle University Of Thessaloniki

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

Study Overview

Status

Enrolling by invitation

Conditions

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:

  1. Age, sex of patient
  2. Relevant medical history
  3. Smoking history
  4. Compliance to recall appointments
  5. Early implant losses
  6. Years of prosthetic loading of implants
  7. Implant characteristics (length, diameter, surface, cylindrical or root-shaped)
  8. Type of prosthesis (single or multiple abutments, cemented or screw-retained)
  9. Biological complications (mucositis, peri-implantitis)
  10. Prosthetic complications (minor, moderate or severe)
  11. History of periodontal disease and treatment prior or after implant placement
  12. Prosthetic work performed by specialist or general practitioner
  13. Maintenance performed by specialist or general practitioner
  14. Relevant ridge augmentation procedures during or before implant placement
  15. Clinical measurements (Pocket depth, Attachment loss, Bleeding on probing, presence of Plaque) on six site for every implant (MB, B, DB, ML, L, DL)
  16. 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
  17. A radiograph will be taken with the parallel cone technique and compared to baseline xrays after implant placement to measure bone stability
  18. 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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 54124
        • School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Uncontrolled medical conditions
  • Active uncontrolled periodontal disease
  • Inability to present for the reevaluation appointment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10-22 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Survival and Success Rates
Time Frame: 10-22 years
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
10-22 years
Incidence of peri-implant pathology
Time Frame: 10-22 years
The percentages of implants that are healthy, have peri-implant mucositis or peri-implantitis
10-22 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcome Measures
Time Frame: 10-22 years
Patients will fill out a questionnaire with 13 targeted questions pertaining to their satisfaction with implant treatment. Patients circled one of the possible answers to each question ("Yes, definitely", "Enough", "Not so", "Definitely not", "Don't know", "No anwswer")
10-22 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Principal Investigator: Ioannis Vouros, DDS PHD, Aristotle University of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

May 30, 2025

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 458/16-4-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Start date: July , 2025 End date: December 2025

IPD Sharing Access Criteria

Any scientist with an interest in this kind of research

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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