Overview

This trial is active, not recruiting.

Conditions jaw, edentulous, partially, jaw, edentulous
Sponsor AZ Sint-Jan AV
Start date January 2001
End date July 2016
Trial size 150 participants
Trial identifier NCT02661412, B049201627038

Summary

Since its introduction in the late 1990s, immediate implant loading concepts (IL) have become a frequent alternative for delayed implant procedures. IL concepts reduce chair time, the number of surgical interventions and pain, and offer instant comfort to the patient. Its reduced treatment time results in obvious socioeconomic advantages. Although there is at present abundant evidence that supports IL, evaluation of long-term biological and mechanical stability outcomes of large patient populations could allow quality improvement and more accurate patient selection. The Departments of Oral and Maxillofacial Surgery and the Department of Dentistry of the General Hospital Saint-John Bruges act as one of the pioneers of IL in Belgium, routinely performing the concept since 2001.

The investigators aim to evaluate the biological and mechanical short- and long-term outcome of IL in partially or completely edentulous patients. Moreover, the investigators aim to detect potential influencing risk factors predicting undesirable prosthetic outcome.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective

Primary Outcomes

Measure
implant survival rate
time frame: within 6 months post placement of implants
implant survival rate
time frame: until a maximum of 15 years of follow-up

Secondary Outcomes

Measure
Infection rate
time frame: within 6 months post placement of implants
Infection rate
time frame: until a maximum of 15 years of follow-up
correlation between patient-mediated factors (age, gender, comorbidities, etc) and occurrence of implant instability, as clinically evaluated by the treating surgeon
time frame: within 6 months post placement of implants
correlation between patient-mediated factors (age, gender, comorbidities, etc) and occurrence of implant instability, as clinically evaluated by the treating surgeon
time frame: until a maximum of 15 years of follow-up
correlation between clinical factors (surgeon, surgical procedure, etc) as and the occurrence of implant instability, as clinically evaluated by the treating surgeon
time frame: within 6 months post placement of implants
correlation between clinical factors (surgeon, surgical procedure, etc) as and the occurrence of implant instability, as clinically evaluated by the treating surgeon
time frame: until a maximum of 15 years of follow-up
correlation between implant characteristics (design/finish/material) and occurrence of implant instability, as clinically evaluated by the treating surgeon
time frame: within 6 months post placement of implants
correlation between implant characteristics (design/finish/material) and occurrence of implant instability, as clinically evaluated by the treating surgeon
time frame: until a maximum of 15 years of follow-up

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - patients of all ages - patients of all genders - patients with partially or complete edentulous jaw - patients treated at the department between 01/01/2001 and 31/12/2015 Exclusion Criteria: - patients not eligible according to abovementioned criteria - patients who required horizontal bone augmentation procedures of the complete alveolar bone - patients who required a jaw reconstruction after tumor resection, osteoradionecrosis or medication-related osteonecrosis of the jaw

Additional Information

Principal investigator Johan Abeloos, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by AZ Sint-Jan AV.