Prospective Registry of Immediate/Delayed Loading of Implants in the Cranial Bone-grafted Severely Atrophic Jaw

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Registry of Immediate/Delayed Loading of Implants in the Cranial Bone-grafted Severely Atrophic Jaw

Conditions
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Jaw, Edentulous, Jaw, Partially Edentulous

Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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