IMLOAD: Immediate Loading of Implants in the Partially or Completely Edentulous Jaw

Sponsor

AZ Sint-Jan AV (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02661412

Collaborator

(none)

150

Enrollment

Location

192

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Jaw, Edentulous, Partially Jaw, Edentulous

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.

Study Design

Study Type:

Observational

Actual Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Immediate Loading of Implants in the Partially or Completely Edentulous Jaw

Actual Study Start Date :

Dec 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2030

Anticipated Study Completion Date :

Dec 1, 2031

Outcome Measures

Primary Outcome Measures

implant survival rate [within 6 months post placement of implants]
Percentage of people in the study for which implant is still present of the fixture in the oral cavity
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

Infection rate [within 6 months post placement of implants]
Percentage of people in the study that develop an infection at the site of the implant in the oral cavity
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 patient-mediated factors and occurrence of implant instability [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
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
correlation between clinical factors and the occurrence of implant instability [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
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
correlation between implant characteristics and occurrence of implant instability [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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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