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

Sponsor

AZ Sint-Jan AV (Other)

Overall Status

Terminated

CT.gov ID

NCT02664298

Collaborator

(none)

120

Enrollment

Location

169

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Jaw, Edentulous Jaw, Partially Edentulous

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Feb 1, 2021

Actual Study Completion Date :

Feb 1, 2021

Outcome Measures

Primary Outcome Measures

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

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]

Other Outcome Measures

patient satisfaction, through visual analogue scale [within 12 months postsurgery (short-term); at annual follow-up until a maximum of 10 years follow-up (long-term)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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)