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

NCT ID: NCT02664298

Last Updated: 2022-02-28

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2021-02-28

Brief Summary

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.

Conditions

Jaw, Edentulous; Jaw, Partially Edentulous

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AZ Sint-Jan AV

OTHER

Sponsor Role: lead

Responsible Party

Johan Abeloos

Maxillofacial Surgeon, Head of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johan Abeloos, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Bruges, Belgium

Locations

Araceli Diez-Fraile

Bruges, Other (Non U.s.), Belgium

Countries

Belgium

Other Identifiers

B049201525497

Identifier Type: -

Identifier Source: org_study_id