NCT02664298|Terminated
Study Stopped
Registry of patients registry has been discontinued
Prospective Registry of Immediate/Delayed Loading of Implants in the Cranial Bone-grafted Severely Atrophic Jaw
ILICRAN
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Sponsor study identifier
observational
120
1 country
1
Study Start
January 2007
Actual (reported)Primary Completion
February 2021
Actual (reported)Study Completion
February 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2007
Actual (reported)January 11, 2016
Actual (reported)January 27, 2016
Actual (reported)February 2021
Actual (reported)February 2021
Actual (reported)IPI survival rate at time of immediate loading in patients with cranial bone-grafted severely atrophic jaw
within 6 months postsurgery
definitive implant survival rate in patients with cranial bone-grafted severely atrophic jaw
within 12 months postoperative
bone-graft resorption, as evaluated through cone-beam computed tomography
within 12 months postoperative
prosthesis survival rate
all consenting patients that require fixed prosthetic rehabilitation in a cranial bone-grafted severely atrophic jaw
Araceli Diez-Fraile
Bruges, Other (Non U.s.), 8000, Belgium
Johan Abeloos, MD
Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Bruges, Belgium
120 participants (actual enrollment reported by the registry).
First Submitted
January 11, 2016
First Posted
January 27, 2016
Study Start
January 2007
Actual (reported)Comparison of Synthetic Bone Substitute and a Bovine-derived Xenograft in Horizontal Bone Augmentation
until a maximum of 10 years follow-up
bone-graft resorption, as evaluated through cone-beam computed tomography
until a maximum of 10 years follow-up
Prevalence of patients with severely atrophic jaw requiring cranial bone-grafting
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
within 12 months postsurgery
patient satisfaction, through visual analogue scale
within 12 months postsurgery (short-term); at annual follow-up until a maximum of 10 years follow-up (long-term)
Contact the study team to confirm eligibility.
Primary Completion
February 2021
Actual (reported)Study Completion
February 2021
Actual (reported)Last Updated
February 28, 2022
Record last verified: 2022-02
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Source: ClinicalTrials.gov.
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