Immediate Loading of Implants in the Partially or Completely Edentulous Jaw

Jaw, Edentulous, Partially Clinical Trial

— IMLOAD  

Official title:

Immediate Loading of Implants in the Partially or Completely Edentulous Jaw

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02661412
• Other study ID #: B049201627038
• Status: Active, not recruiting
• Start date: December 2015
• Est. completion date: December 2031

Study information

• Verified date: February 2022
• Source: AZ Sint-Jan AV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2031
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially
• Mouth, Edentulous

Locations

Country	Name	City	State
Belgium	General Hospital Saint-John Bruges	Bruges

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	implant survival rate	Percentage of people in the study for which implant is still present of the fixture in the oral cavity	within 6 months post placement of implants
Primary	implant survival rate	Percentage of people in the study for which implant is still present of the fixture in the oral cavity	until a maximum of 15 years of follow-up
Secondary	Infection rate	Percentage of people in the study that develop an infection at the site of the implant in the oral cavity	within 6 months post placement of implants
Secondary	Infection rate	Percentage of people in the study that develop an infection at the site of the implant in the oral cavity	until a maximum of 15 years of follow-up
Secondary	correlation between patient-mediated factors and occurrence of implant instability	correlation between patient-mediated factors (age, gender, comorbidities, etc) and occurrence of implant instability, as clinically evaluated by the treating surgeon	within 6 months post placement of implants
Secondary	correlation between patient-mediated factors and occurrence of implant instability	correlation between patient-mediated factors (age, gender, comorbidities, etc) and occurrence of implant instability, as clinically evaluated by the treating surgeon	until a maximum of 15 years of follow-up
Secondary	correlation between clinical factors and the occurrence of implant instability	correlation between clinical factors (surgeon, surgical procedure, etc) as and the occurrence of implant instability, as clinically evaluated by the treating surgeon	within 6 months post placement of implants
Secondary	correlation between clinical factors and the occurrence of implant instability	correlation between clinical factors (surgeon, surgical procedure, etc) as and the occurrence of implant instability, as clinically evaluated by the treating surgeon	until a maximum of 15 years of follow-up
Secondary	correlation between implant characteristics and occurrence of implant instability	correlation between implant characteristics (design/finish/material) and occurrence of implant instability, as clinically evaluated by the treating surgeon	within 6 months post placement of implants
Secondary	correlation between implant characteristics and occurrence of implant instability	correlation between implant characteristics (design/finish/material) and occurrence of implant instability, as clinically evaluated by the treating surgeon	until a maximum of 15 years of follow-up