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.
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.
Study Type
OBSERVATIONAL
Enrollment
16
additional CBCT scan at 24 and 36 months, for analysis of evolution of bone volume
Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV
Bruges, Belgium
mean total bone volume changes (%)
Time frame: 6, 24, and 36 months post surgery
correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes
Time frame: short-term (6 months)
correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes
Time frame: long-term (24 months)
correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes
Time frame: long-term (36 months)
correlation between mechanical risk factors, as measured through clinical or radiographical visualization by the treating surgeon and/or prosthodontist, with undesirable bone volume changes
Time frame: short-term (6 months)
correlation between mechanical risk factors, as measured through clinical or radiographical visualization by the treating surgeon and/or prosthodontist, with undesirable bone volume changes
Time frame: long-term (24 months)
correlation between mechanical risk factors, as measured through clinical or radiographical visualization by the treating surgeon and/or prosthodontist, with undesirable bone volume changes
Time frame: long-term (36 months)
incidence of immediate provisional implants loss
Time frame: up to 6 months
incidence of definitive implant loss
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Time frame: up to 36 months