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

NCT06803576 | Enrolling By Invitation

• 1 other identifier: 458/16-4-2021
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Pocket Depth; Attachment Loss; Bone Loss in Jaw

Keywords

dental implants; biologic complications; biomet 3i; Long-term results; prosthetic complications

Outcome Measures

Primary Outcomes (1)

• 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

  10-22 years

Secondary Outcomes (2)

• Implant Survival and Success Rates

  10-22 years

• Incidence of peri-implant pathology

  10-22 years

Other Outcomes (1)

• Patient-Reported Outcome Measures

  10-22 years

Study Arms (1)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

School of Dentistry

Thessaloniki, 54124, Greece

Location

Related Publications (4)

• Amelie Bäumer1,2*, Shirin Toekan3, Daniel Saure4 and Gerd Körner2

  BACKGROUND

• 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.

  PMID: 36807599 BACKGROUND

• Chappuis 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.

  PMID: 23506385 BACKGROUND

• Frisch 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.

  PMID: 31599464 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peri-implant sulcular fluid

Study Officials

• Ioannis Vouros, DDS PHD

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: January 1, 2025
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Start date: July , 2025 End date: December 2025
• Access Criteria: Any scientist with an interest in this kind of research

Locations

GR (1)