NCT02810184

Determination of Bone Volume Changes of the Cranial Bone-augmented Jaw: A Feasibility Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 16 (actual)
• Sponsor: AZ Sint-Jan AV · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The investigators aim to determine the level of total bone volume remodeling at 6, 24 and 36 months post-surgery in patients who underwent immediate prosthetic rehabilitation through a cranial bone-grafted maxilla in combination with immediate provisional implant (IPI) placement.

Detailed description

Background Bone augmentation provides a solution for patients with a severely atrophic jaw to achieve immediate fixed prosthetic rehabilitation. Studies reporting total bone volume changes are lacking. Objectives The investigators aim to determine the level of total bone volume remodeling at 6, 24 and 36 months post-surgery in patients who underwent immediate prosthetic rehabilitation through a cranial bone-grafted maxilla in combination with immediate provisional implant (IPI) placement. Study design A prospective, longitudinal study. All patients will be recruited at time of pre-surgical consultation. During the surgical procedure, autogenous cranial graft reconstruction of the jaw is carried out under general anaesthesia. Cone-beam CT (CBCT) scans (NewTom VGi evo, QR Verona, Italy) will be taken pre-operatively, and at different time-points post-operatively to evaluate the remodeling process of the bone after the grafting procedure with implant placements and assess the total bone volume changes up to 3 years post-surgically. CBCT scans will be send to the oral maxillofacial surgery (OMFS) Research Group within the Department of Imaging and Pathology (IMPATH), Catholic University Leuven (liaised with the clinical department of Oral and Maxillofacial Surgery; University Hospital Leuven) for analysis of the total bone volume. Data related to patient demographics, clinical diagnosis, the surgical procedure, IPI stability, and total bone volume at different time-points will be registered by a clinical research coordinator. Conclusion This prospective trial could add important knowledge to the field, and provide indications to improve future clinical pre-prosthetic management.

Conditions

• Severely Atrophic Jaw

Interventions

Type	Name	Description
RADIATION	cone-beam computed tomography (CBCT)	additional CBCT scan at 24 and 36 months, for analysis of evolution of bone volume

Timeline

• Start date: 2016-06-01
• Primary completion: 2022-12-01
• Completion: 2023-07-01
• First posted: 2016-06-22
• Last updated: 2022-02-28

Locations

1 site across 1 country: Belgium