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

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 Overview

• Status: Active, not recruiting
• Conditions: 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.

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 Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Belgium
  • Bruges, Belgium
    • General Hospital Saint-John Bruges

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients of all ages with loss of all or almost all teeth due to terminal periodontal disease and/or untreatable endodontic problems, that requested treatment according to the IL protocol between 01/01/2001 and 31/12/2015. Patients should have adequate bone volume to predominantly receive an implant of ≥13x3.5mm anteriorly and an implant of ≥9 x 3.5mm posteriorly. All patients, with or without a pre-prosthetic sinus floor augmentation, are included in de study.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV
• Investigators: Principal Investigator: Johan Abeloos, MD, division of maxillofacial surgery, department of surgery, general hospital Saint-John Bruges

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2015
• Primary Completion (ANTICIPATED): December 1, 2030
• Study Completion (ANTICIPATED): December 1, 2031

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: January 19, 2016
• First Posted (ESTIMATE): January 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: dental implant; marginal bone level; immediate loading; long-term; maxilla; immediate placement; biological stability; mechanical stability; fibre-reinforced provisional fixed prosthesis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous; Jaw, Edentulous, Partially
• Other Study ID Numbers: B049201627038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No