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

NCT02664298 | Terminated

• 1 other identifier: B049201525497
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• 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 Outcomes (1)

• 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

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all consenting patients that require fixed prosthetic rehabilitation in a cranial bone-grafted severely atrophic jaw

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (1)

Araceli Diez-Fraile

Bruges, Other (Non U.s.), 8000, Belgium

Location

MeSH Terms

Conditions

Jaw, Edentulous; Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• Johan Abeloos, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maxillofacial Surgeon, Head of Department

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 27, 2016
• Study Start: January 1, 2007
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)