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

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 Overview

• Status: Active, not recruiting
• Conditions: Severely Atrophic Jaw
• Intervention / Treatment: Radiation: cone-beam computed tomography (CBCT)

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.

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Belgium
  • Bruges, Belgium
    • Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CBCT arm; all participating patients receive an additional CBCT scan at 24 and 36 months, for analysis of evolution of bone volume	Radiation: cone-beam computed tomography (CBCT); additional CBCT scan at 24 and 36 months, for analysis of evolution of bone volume

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mean total bone volume changes (%)	6, 24, and 36 months post surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes	short-term (6 months)
correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes	long-term (24 months)
correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes	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	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	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	long-term (36 months)
incidence of immediate provisional implants loss	up to 6 months
incidence of definitive implant loss	up to 36 months

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV
• Investigators: Principal Investigator: Johan Abeloos, MD, PhD, head of department

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: June 13, 2016
• First Submitted That Met QC Criteria: June 21, 2016
• First Posted (Estimate): June 22, 2016

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: bone augmentation; long-term bone volume changes; immediate provisional implant
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: B049201627591

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No