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

• Conditions: Pocket Depth; Attachment Loss; Bone Loss in Jaw

• Registration Number: NCT06803576
• Lead Sponsor: Aristotle University Of Thessaloniki

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

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 Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-01-27
• Study First Posted: 2025-01-31
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiographic Marginal Bone loss	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

Secondary Outcome Measures

Name	Time	Method
Implant Survival and Success Rates	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
Incidence of peri-implant pathology	10-22 years	The percentages of implants that are healthy, have peri-implant mucositis or peri-implantitis

Trial Locations

Locations (1)

School of Dentistry; 🇬🇷 Thessaloniki, Greece