Clinical trial NCT02810184: Determination of Bone Volume Changes of the Cranial Bone-augmented Jaw: A Feasibility Study
Official title: Determination of Bone Volume Changes of the Cranial Bone-augmented Jaw: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severely Atrophic Jaw
Keywords: bone augmentation
long-term bone volume changes
immediate provisional implant
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients of all ages
* 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 requesting immediate prosthetic rehabilitation, through the placement of an immediate provisional implant (IPI)-supported fixed bridge (immediate loading)

Exclusion Criteria:

* Patients not fulfilling abovementioned criteria
* Patients with severe uncontrollable diabetes
* Patients with a smoking habit of \>10 cigarettes/day
* Patients with severe sinusitis problems
* Patients with insufficient cranial bone thickness
* Patients with bone remodeling or systemic diseases, or undergoing systematically administered treatments affecting bone remodeling
* Patients in whom postoperative complications (e.g. sinusitis, infections) occurred, will be excluded from the analysis, since these could be responsible for short-term bone volume loss confounding long-term results

Primary outcomes:
measure: mean total bone volume changes (%)
timeFrame: 6, 24, and 36 months post surgery
Secondary outcomes:
measure: correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes
timeFrame: short-term (6 months)
measure: correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes
timeFrame: long-term (24 months)
measure: correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes
timeFrame: long-term (36 months)
measure: correlation between mechanical risk factors, as measured through clinical or radiographical visualization by the treating surgeon and/or prosthodontist, with undesirable bone volume changes
timeFrame: short-term (6 months)
measure: correlation between mechanical risk factors, as measured through clinical or radiographical visualization by the treating surgeon and/or prosthodontist, with undesirable bone volume changes
timeFrame: long-term (24 months)
measure: correlation between mechanical risk factors, as measured through clinical or radiographical visualization by the treating surgeon and/or prosthodontist, with undesirable bone volume changes
timeFrame: long-term (36 months)
measure: incidence of immediate provisional implants loss
timeFrame: up to 6 months
measure: incidence of definitive implant loss
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Bruges
country: Belgium
facility: Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV
Study officials:
affiliation: Head of Department
name: Johan Abeloos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: