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

Jaw, Edentulous Clinical Trial

— ILICRAN  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02664298
• Other study ID #: B049201525497
• Status: Terminated
• Start date: January 2007
• Est. completion date: February 2021

Study information

• Verified date: February 2022
• Source: AZ Sint-Jan AV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrophy
• Jaw, Edentulous
• Jaw, Partially Edentulous
• Mouth, Edentulous

Locations

Country	Name	City	State
Belgium	Araceli Diez-Fraile	Brugge	Other (Non U.s.)

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	IPI survival rate at time of immediate loading in patients with cranial bone-grafted severely atrophic jaw		within 6 months postsurgery
Primary	definitive implant survival rate in patients with cranial bone-grafted severely atrophic jaw		within 12 months postoperative
Primary	bone-graft resorption, as evaluated through cone-beam computed tomography		within 12 months postoperative
Primary	prosthesis survival rate		until a maximum of 10 years follow-up
Primary	bone-graft resorption, as evaluated through cone-beam computed tomography		until a maximum of 10 years follow-up
Secondary	Prevalence of patients with severely atrophic jaw requiring cranial bone-grafting		every 12 months, until a maximum of ten years
Secondary	Potential biologic or mechanical risk factors that could predict undesirable functional or aesthetic outcome, through regression analysis		within 12 months postsurgery