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OpenTrials
Active, Not Recruiting

NCT Number: NCT02661412

Immediate Loading of Implants in the Partially or Completely Edentulous Jaw

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital Saint-John Bruges

Bruges, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. implant survival rate

    Time frame: 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

  2. implant survival rate

    Time frame: 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 outcomes

  1. Infection rate

    Time frame: 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

  2. Infection rate

    Time frame: 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

  3. correlation between patient-mediated factors and occurrence of implant instability

    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

  4. correlation between patient-mediated factors and occurrence of implant instability

    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

  5. correlation between clinical factors and the occurrence of implant instability

    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

  6. correlation between clinical factors and the occurrence of implant instability

    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

  7. correlation between implant characteristics and occurrence of implant instability

    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

  8. correlation between implant characteristics and occurrence of implant instability

    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

Sponsors and collaborators

Lead sponsor

AZ Sint-Jan AV

Other

Registry information

Acronym: IMLOAD

Important dates

Study start
2015
Primary completion
2030
Study completion
2031
First posted
Jan 22, 2016
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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