Jaw, Edentulous Clinical Trial
NCT02664298
| Observational patient registry
This study has recruited 120 Participants
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.
Details for the study
Population
all consenting patients that require fixed prosthetic rehabilitation in a cranial
bone-grafted severely atrophic jaw
Brief Title
Prospective Registry of Immediate/Delayed Loading of Implants in the Cranial Bone-grafted Severely Atrophic Jaw
Official Title
Prospective Registry of Immediate/Delayed Loading of Implants in the Cranial Bone-grafted Severely Atrophic Jaw
Brief Summary
Edentulism is often associated with a negative psychosocial impact. The concept of prosthetic
<br /> rehabilitation in which a prosthesis is supported by osseointegrated implants, was first
<br /> introduced in the late 1960s by Brånemark et al. and offers an interesting alternative to
<br /> removable prosthesis. However, for patients with a severely atrophic maxilla or mandible,
<br /> cranial bone grafting of the jaw is required to increase bone width and height necessary for
<br /> implant insertion. An active collaboration between the surgeons from the Oral and
<br /> Maxillofacial Department and the prosthodontist from the Department of Dentistry has been
<br /> established for continuous quality improvement of the concept of (immediate/delayed) implant
<br /> loading in patients requiring cranial bone grafts to augment their severely atrophic jawbone.
<br />
<br /> The investigators aim to develop a prospective database registering (immediate/delayed)
<br /> implant loading data of all patients eligible according to the protocol. Patient
<br /> demographics, surgical, dental, prosthetic and patient satisfaction parameters are collected
<br /> during consecutive visits within the framework of routine practice.
<br />
<br /> Development of a database registering immediate functional loading data secondary to cranial
<br /> bone-grafting of a severely atrophic jaw, will provide more information about potential
<br /> patient, surgical and prosthetic factors influencing long-term biological and mechanical
<br /> stability, as well as patient satisfaction. Moreover, registration of those results could
<br /> function as a measurement of quality of care, and could be used for sample size calculation
<br /> for future large prospective trials.
Study Criteria
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)