Clinical trial NCT06803576: Clinical and Microbiological Outcomes of Dental Implants After 10-22 Years of Function
Official title: Clinical and Microbiological Parameters of Success Following the Application of Osseointegrated Dental Implants. A 10-year Retrospective Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pocket Depth
Attachment Loss
Bone Loss in Jaw
Keywords: dental implants
biologic complications
biomet 3i
Long-term results
prosthetic complications
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Radiographic Marginal Bone loss
timeFrame: 10-22 years
Secondary outcomes:
measure: Implant Survival and Success Rates
timeFrame: 10-22 years
measure: Incidence of peri-implant pathology
timeFrame: 10-22 years
Other outcomes:
measure: Patient-Reported Outcome Measures
timeFrame: 10-22 years
Locations:
city: Thessaloniki
country: Greece
facility: School of Dentistry
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Ioannis Vouros, DDS PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amelie Bäumer1,2*, Shirin Toekan3, Daniel Saure4 and Gerd Körner2
citation: 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.
citation: 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.
citation: 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.