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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title:

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.


Detailed Summary:
Sponsor: AZ Sint-Jan AV

Current Primary Outcome:

  • IPI survival rate at time of immediate loading in patients with cranial bone-grafted severely atrophic jaw [ Time Frame: within 6 months postsurgery ]
  • definitive implant survival rate in patients with cranial bone-grafted severely atrophic jaw [ Time Frame: within 12 months postoperative ]
  • bone-graft resorption, as evaluated through cone-beam computed tomography [ Time Frame: within 12 months postoperative ]
  • prosthesis survival rate [ Time Frame: until a maximum of 10 years follow-up ]
  • bone-graft resorption, as evaluated through cone-beam computed tomography [ Time Frame: until a maximum of 10 years follow-up ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Prevalence of patients with severely atrophic jaw requiring cranial bone-grafting [ Time Frame: 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 [ Time Frame: within 12 months postsurgery ]


Original Secondary Outcome: Same as current

Information By: AZ Sint-Jan AV

Dates:
Date Received: January 11, 2016
Date Started: January 2007
Date Completion: December 2020
Last Updated: January 22, 2016
Last Verified: January 2016