Clinical trial NCT02661412: Immediate Loading of Implants in the Partially or Completely Edentulous Jaw
Official title: Immediate Loading of Implants in the Partially or Completely Edentulous Jaw
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Jaw, Edentulous, Partially
Jaw, Edentulous
Keywords: immediate loading
biological stability
mechanical stability
long-term
marginal bone level
maxilla
immediate placement
dental implant
fibre-reinforced provisional fixed prosthesis
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2016-01-22
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: implant survival rate
timeFrame: within 6 months post placement of implants
measure: implant survival rate
timeFrame: until a maximum of 15 years of follow-up
Secondary outcomes:
measure: Infection rate
timeFrame: within 6 months post placement of implants
measure: Infection rate
timeFrame: until a maximum of 15 years of follow-up
measure: correlation between patient-mediated factors and occurrence of implant instability
timeFrame: within 6 months post placement of implants
measure: correlation between patient-mediated factors and occurrence of implant instability
timeFrame: until a maximum of 15 years of follow-up
measure: correlation between clinical factors and the occurrence of implant instability
timeFrame: within 6 months post placement of implants
measure: correlation between clinical factors and the occurrence of implant instability
timeFrame: until a maximum of 15 years of follow-up
measure: correlation between implant characteristics and occurrence of implant instability
timeFrame: within 6 months post placement of implants
measure: correlation between implant characteristics and occurrence of implant instability
timeFrame: until a maximum of 15 years of follow-up
Other outcomes:
Locations:
city: Bruges
country: Belgium
facility: General Hospital Saint-John Bruges
Study officials:
affiliation: division of maxillofacial surgery, department of surgery, general hospital Saint-John Bruges
name: Johan Abeloos, MD
role: PRINCIPAL_INVESTIGATOR
References: