- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02664298
Prospective Registry of Immediate/Delayed Loading of Implants in the Cranial Bone-grafted Severely Atrophic Jaw (ILICRAN)
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Other (Non U.s.)
-
Brugge, Other (Non U.s.), Belgium, 8000
- Araceli Diez-Fraile
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
IPI survival rate at time of immediate loading in patients with cranial bone-grafted severely atrophic jaw
Time Frame: within 6 months postsurgery
|
within 6 months postsurgery
|
definitive implant survival rate in patients with cranial bone-grafted severely atrophic jaw
Time Frame: within 12 months postoperative
|
within 12 months postoperative
|
bone-graft resorption, as evaluated through cone-beam computed tomography
Time Frame: within 12 months postoperative
|
within 12 months postoperative
|
prosthesis survival rate
Time Frame: until a maximum of 10 years follow-up
|
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
|
until a maximum of 10 years follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevalence of patients with severely atrophic jaw requiring cranial bone-grafting
Time Frame: every 12 months, until a maximum of ten years
|
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
|
within 12 months postsurgery
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
patient satisfaction, through visual analogue scale
Time Frame: within 12 months postsurgery (short-term); at annual follow-up until a maximum of 10 years follow-up (long-term)
|
within 12 months postsurgery (short-term); at annual follow-up until a maximum of 10 years follow-up (long-term)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Johan Abeloos, MD, Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Bruges, Belgium
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B049201525497
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Jaw, Edentulous
-
Dentsply Sirona Implants and ConsumablesCompletedPartially Edentulous JawChina
-
University of Alabama at BirminghamZimmer DentalCompleted
-
Dentsply Sirona Implants and ConsumablesCompletedPartially Edentulous JawChina
-
Dentsply Sirona Implants and ConsumablesCompletedPartially Edentulous JawChina
-
Dentsply Sirona Implants and ConsumablesCompleted
-
Dentsply Sirona Implants and ConsumablesCompleted
-
University of IowaEnrolling by invitationEdentulous Jaw | Edentulous MouthUnited States
-
Concordia Dent SrlITI International Team for Implantology, SwitzerlandCompletedMANDIBLE | ATROPHYC EDENTULOUS JAWRomania
-
Cairo UniversityUnknownEdentulous Alveolar Ridge | Edentulous Jaw | Edentulous MouthEgypt
-
Lithuanian University of Health SciencesHacettepe University; University of Michigan; University of Messina; Universidad...UnknownPartially Edentulous JawLithuania