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

AZ Sint-Jan AV

Status: Terminated

Conditions: Jaw, Partially Edentulous; Jaw, Edentulous

Study type: Observational

Funder types: Other

Identifiers

NCT02664298

B049201525497

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Volunteers: No Healthy Volunteers

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)