Immediate Loading of Implants in the Partially or Completely Edentulous Jaw

Active, not recruiting

• Conditions: Jaw, Edentulous, Partially; Jaw, Edentulous

• Registration Number: NCT02661412
• Lead Sponsor: AZ Sint-Jan AV

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-01-19
• Study First Posted: 2016-01-22
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-02-28
• Primary Completion: 2030-12
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
implant survival rate	until a maximum of 15 years of follow-up	Percentage of people in the study for which implant is still present of the fixture in the oral cavity

Secondary Outcome Measures

Name	Time	Method
correlation between patient-mediated factors and occurrence of implant instability	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
Infection rate	until a maximum of 15 years of follow-up	Percentage of people in the study that develop an infection at the site of the implant in the oral cavity
correlation between implant characteristics and occurrence of implant instability	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
correlation between clinical factors and the occurrence of implant instability	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

Trial Locations

Locations (1)

General Hospital Saint-John Bruges; 🇧🇪 Bruges, Belgium