Jaw, Edentulous, PartiallyIMLOADNCT02661412
Immediate Loading of Implants in the Partially or Completely Edentulous Jaw
An observational study of Jaw, Edentulous, Partially and Jaw, Edentulous, run by AZ Sint-Jan AV at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Jaw, Edentulous, Partially, Jaw, Edentulous
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2015to Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- 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
- Medical subject headings
- Jaw, Edentulous, Partially, Jaw, Edentulous
What is being measured
The primary outcome is the main question the study is designed to answer.
implant survival rate
Percentage of people in the study for which implant is still present of the fixture in the oral cavity
Measured: 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
Measured: until a maximum of 15 years of follow-up
Secondary outcomes (8)
Infection rate
Percentage of people in the study that develop an infection at the site of the implant in the oral cavity
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: until a maximum of 15 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2030 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw, Edentulous, PartiallyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Abeloos, AZ Sint-Jan AV
- Investigators
- Johan Abeloos, MD, Principal investigator, division of maxillofacial surgery, department of surgery, general hospital Saint-John Bruges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661412
- Sponsor's protocol ID
- B049201627038
- Acronym
- IMLOAD
- Status last verified
- Feb 2022
- First submitted
- 11 Jan 2016
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Loading of Implants in the Partially or Completely Edentulous Jaw
- ClinicalTrials.gov ID
- NCT02661412
- Acronym / sponsor ID
- IMLOAD / B049201627038
- Conditions
- Jaw, Edentulous, Partially, Jaw, Edentulous
- Keywords
- immediate loading, biological stability, mechanical stability, long-term, marginal bone level, maxilla, immediate placement, dental implant
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 22 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
8 secondary outcomes
Infection rate
Time frame: within 6 months post placement of implants
Infection rate
Time frame: until a maximum of 15 years of follow-up
correlation between patient-mediated factors and occurrence of implant instability
Time frame: within 6 months post placement of implants
correlation between patient-mediated factors and occurrence of implant instability
Time frame: until a maximum of 15 years of follow-up
correlation between clinical factors and the occurrence of implant instability
Time frame: within 6 months post placement of implants
correlation between clinical factors and the occurrence of implant instability
Time frame: until a maximum of 15 years of follow-up
correlation between implant characteristics and occurrence of implant instability
Time frame: within 6 months post placement of implants
correlation between implant characteristics and occurrence of implant instability
Time frame: until a maximum of 15 years of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Abeloos, MD principal investigator
division of maxillofacial surgery, department of surgery, general hospital Saint-John Bruges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Jaw, Edentulous, Partially and Jaw, Edentulous, run by AZ Sint-Jan AV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
implant survival rate (time frame: within 6 months post placement of implants). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.