Jaw, EdentulousILICRANNCT02664298
Prospective Registry of Immediate/Delayed Loading of Implants in the Cranial Bone-grafted Severely Atrophic Jaw
An observational study of Jaw, Edentulous and Jaw, Partially Edentulous, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial summary
Edentulism is often associated with a negative psychosocial impact. The concept of prosthetic rehabilitation in which a prosthesis is supported by osseointegrated implants, was first introduced in the late 1960s by Brånemark et al. and offers an interesting alternative to removable prosthesis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Jaw, Edentulous, Jaw, Partially Edentulous
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2007to Feb 2021
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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: all consenting patients that require fixed prosthetic rehabilitation in a cranial bone-grafted severely atrophic jaw
Who may be able to join
- Patients of all ages
- Patients of all genders
- Patients with moderate to extreme bone atrophy of the jaw (class IV to VI according to Cawood and Howell (Cawood \& Howell, 1988), caused by terminal periodontitis or edentulism
- Patients requiring bone augmentation procedures through cranial bone grafting for jaw reconstruction
- Patients ineligible for conventional removable prosthetic rehabilitation
Who cannot join
- Patients not eligible according to abovementioned criteria
- Patients with severe uncontrolled diabetes
- Patients with cranial vault without diploe and/or cranial vault thickness <3mm, as defined with cone-beam CT (De Ceulaer, et al., 2012)
Trial locations and contacts
1 site in 1 country.
About this study
Edentulism is often associated with a negative psychosocial impact. The concept of prosthetic rehabilitation in which a prosthesis is supported by osseointegrated implants, was first introduced in the late 1960s by Brånemark et al. and offers an interesting alternative to removable prosthesis. However, for patients with a severely atrophic maxilla or mandible, cranial bone grafting of the jaw is required to increase bone width and height necessary for implant insertion. An active collaboration between the surgeons from the Oral and Maxillofacial Department and the prosthodontist from the Department of Dentistry has been established for continuous quality improvement of the concept of (immediate/delayed) implant loading in patients requiring cranial bone grafts to augment their severely atrophic jawbone.
The investigators aim to develop a prospective database registering (immediate/delayed) implant loading data of all patients eligible according to the protocol. Patient demographics, surgical, dental, prosthetic and patient satisfaction parameters are collected during consecutive visits within the framework of routine practice.
Development of a database registering immediate functional loading data secondary to cranial bone-grafting of a severely atrophic jaw, will provide more information about potential patient, surgical and prosthetic factors influencing long-term biological and mechanical stability, as well as patient satisfaction. Moreover, registration of those results could function as a measurement of quality of care, and could be used for sample size calculation for future large prospective trials.
- Conditions
- Jaw, Edentulous, Jaw, Partially Edentulous
- Keywords
- severely atrophic jaw, cranial bone-graft, dental implants, immediate loading, augmentation maxilla/mandible, sinus-floor elevation/sinuslift, dental prosthesis, implant supported, provisional implants, temporary implants, one-stage surgery, alveolar ridge augmentation, maxilla
- Medical subject headings
- Jaw, Edentulous, Jaw, Edentulous, Partially
What is being measured
The primary outcome is the main question the study is designed to answer.
IPI survival rate at time of immediate loading in patients with cranial bone-grafted severely atrophic jaw
Measured: within 6 months postsurgery
definitive implant survival rate in patients with cranial bone-grafted severely atrophic jaw
Measured: within 12 months postoperative
bone-graft resorption, as evaluated through cone-beam computed tomography
Measured: within 12 months postoperative
prosthesis survival rate
Measured: until a maximum of 10 years follow-up
bone-graft resorption, as evaluated through cone-beam computed tomography
Measured: until a maximum of 10 years follow-up
Secondary outcomes (2)
Prevalence of patients with severely atrophic jaw requiring cranial bone-grafting
Measured: every 12 months, until a maximum of ten years
Potential biologic or mechanical risk factors that could predict undesirable functional or aesthetic outcome, through regression analysis
Measured: within 12 months postsurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startJan 2007
- Primary completionFeb 2021
- Study completionFeb 2021
Why it stopped: Registry of patients registry has been discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw, EdentulousStudies 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
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 36 Months
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, Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Bruges, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664298
- Sponsor's protocol ID
- B049201525497
- Acronym
- ILICRAN
- Status last verified
- Feb 2022
- First submitted
- 11 Jan 2016
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- 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
- Prospective Registry of Immediate/Delayed Loading of Implants in the Cranial Bone-grafted Severely Atrophic Jaw
- ClinicalTrials.gov ID
- NCT02664298
- Acronym / sponsor ID
- ILICRAN / B049201525497
- Conditions
- Jaw, Edentulous, Jaw, Partially Edentulous
- Keywords
- severely atrophic jaw, cranial bone-graft, dental implants, immediate loading, augmentation maxilla/mandible, sinus-floor elevation/sinuslift, dental prosthesis, implant supported
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Registry of patients registry has been discontinued
- Enrolment
- 120 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- Jan 2007 (actual)
- Primary completion
- Feb 2021 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 27 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.
Edentulism is often associated with a negative psychosocial impact. The concept of prosthetic rehabilitation in which a prosthesis is supported by osseointegrated implants, was first introduced in the late 1960s by Brånemark et al. and offers an interesting alternative to removable prosthesis. However, for patients with a severely atrophic maxilla or mandible, cranial bone grafting of the jaw is required to increase bone width and height necessary for implant insertion. An active collaboration between the surgeons from the Oral and Maxillofacial Department and the prosthodontist from the Department of Dentistry has been established for continuous quality improvement of the concept of (immediate/delayed) implant loading in patients requiring cranial bone grafts to augment their severely atrophic jawbone.
The investigators aim to develop a prospective database registering (immediate/delayed) implant loading data of all patients eligible according to the protocol. Patient demographics, surgical, dental, prosthetic and patient satisfaction parameters are collected during consecutive visits within the framework of routine practice.
Development of a database registering immediate functional loading data secondary to cranial bone-grafting of a severely atrophic jaw, will provide more information about potential patient, surgical and prosthetic factors influencing long-term biological and mechanical stability, as well as patient satisfaction. Moreover, registration of those results could function as a measurement of quality of care, and could be used for sample size calculation for future large prospective trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all consenting patients that require fixed prosthetic rehabilitation in a cranial bone-grafted severely atrophic jaw
Key inclusion criteria (5 listed)
- Patients of all ages
- Patients of all genders
- Patients with moderate to extreme bone atrophy of the jaw (class IV to VI according to Cawood and Howell (Cawood \& Howell, 1988), caused by terminal periodontitis or edentulism
- Patients requiring bone augmentation procedures through cranial bone grafting for jaw reconstruction
- Patients ineligible for conventional removable prosthetic rehabilitation
Key exclusion criteria (3 listed)
- Patients not eligible according to abovementioned criteria
- Patients with severe uncontrolled diabetes
- Patients with cranial vault without diploe and/or cranial vault thickness <3mm, as defined with cone-beam CT (De Ceulaer, et al., 2012)
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
IPI survival rate at time of immediate loading in patients with cranial bone-grafted severely atrophic jaw
Time frame: within 6 months postsurgery
definitive implant survival rate in patients with cranial bone-grafted severely atrophic jaw
Time frame: within 12 months postoperative
bone-graft resorption, as evaluated through cone-beam computed tomography
Time frame: within 12 months postoperative
prosthesis survival rate
Time frame: until a maximum of 10 years follow-up
bone-graft resorption, as evaluated through cone-beam computed tomography
Time frame: until a maximum of 10 years follow-up
2 secondary outcomes
Prevalence of patients with severely atrophic jaw requiring cranial bone-grafting
Time frame: every 12 months, until a maximum of ten years
Potential biologic or mechanical risk factors that could predict undesirable functional or aesthetic outcome, through regression analysis
Time frame: within 12 months postsurgery
Results and safety
The study was stopped early (reason given: Registry of patients registry has been discontinued). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Jaw, Edentulous
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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
Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Bruges, Belgium
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 and Jaw, Partially 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 5 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: stopped early, 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?
The study was stopped early (reason given: Registry of patients registry has been discontinued). Results are not available in the source record.
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?
IPI survival rate at time of immediate loading in patients with cranial bone-grafted severely atrophic jaw (time frame: within 6 months postsurgery). The study lists 5 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.