Immediate Loading of Implants in the Partially or Completely Edentulous Jaw

NCT02661412 | Active Not Recruiting

• 1 other identifier: B049201627038
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Infection rate

  within 6 months post placement of implants

• Infection rate

  until a maximum of 15 years of follow-up

• correlation between patient-mediated factors and occurrence of implant instability

  within 6 months post placement of implants

• correlation between patient-mediated factors and occurrence of implant instability

  until a maximum of 15 years of follow-up

• correlation between clinical factors and the occurrence of implant instability

  within 6 months post placement of implants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (1)

General Hospital Saint-John Bruges

Bruges, Belgium

Location

MeSH Terms

Conditions

Jaw, Edentulous, Partially; Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• Johan Abeloos, MD

  division of maxillofacial surgery, department of surgery, general hospital Saint-John Bruges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maxillofacial Surgeon, Head of Department

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 22, 2016
• Study Start: December 1, 2015
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)