Clinical trial NCT02664298: Prospective Registry of Immediate/Delayed Loading of Implants in the Cranial Bone-grafted Severely Atrophic Jaw
Official title: Prospective Registry of Immediate/Delayed Loading of Implants in the Cranial Bone-grafted Severely Atrophic Jaw
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Jaw, Edentulous
Jaw, Partially Edentulous
Keywords: severely atrophic jaw
cranial bone-graft
dental implants
immediate loading
augmentation maxilla/mandible
sinus-floor elevation/sinuslift
dental prosthesis
implant supported
provisional implants
temporary implants
one-stage surgery
alveolar ridge augmentation
maxilla
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all consenting patients that require fixed prosthetic rehabilitation in a cranial bone-grafted severely atrophic jaw

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.


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)

Primary outcomes:
measure: IPI survival rate at time of immediate loading in patients with cranial bone-grafted severely atrophic jaw
timeFrame: within 6 months postsurgery
measure: definitive implant survival rate in patients with cranial bone-grafted severely atrophic jaw
timeFrame: within 12 months postoperative
measure: bone-graft resorption, as evaluated through cone-beam computed tomography
timeFrame: within 12 months postoperative
measure: prosthesis survival rate
timeFrame: until a maximum of 10 years follow-up
measure: bone-graft resorption, as evaluated through cone-beam computed tomography
timeFrame: until a maximum of 10 years follow-up
Secondary outcomes:
measure: Prevalence of patients with severely atrophic jaw requiring cranial bone-grafting
timeFrame: every 12 months, until a maximum of ten years
measure: Potential biologic or mechanical risk factors that could predict undesirable functional or aesthetic outcome, through regression analysis
timeFrame: within 12 months postsurgery
Other outcomes:
measure: patient satisfaction, through visual analogue scale
timeFrame: within 12 months postsurgery (short-term); at annual follow-up until a maximum of 10 years follow-up (long-term)
Locations:
city: Brugge
country: Belgium
facility: Araceli Diez-Fraile
state: Other (Non U.s.)
Study officials:
affiliation: Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Bruges, Belgium
name: Johan Abeloos, MD
role: PRINCIPAL_INVESTIGATOR
References: