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

Severely Atrophic Jaw Clinical Trial

— VOLCRAN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02810184
• Other study ID #: B049201627591
• Status: Active, not recruiting
• Start date: June 2016
• Est. completion date: July 2023

Study information

• Verified date: February 2022
• Source: AZ Sint-Jan AV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: July 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Severely Atrophic Jaw

Intervention

Radiation:
• cone-beam computed tomography (CBCT)
additional CBCT scan at 24 and 36 months, for analysis of evolution of bone volume

Locations

Country	Name	City	State
Belgium	Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV	Bruges

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean total bone volume changes (%)		6, 24, and 36 months post surgery
Secondary	correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes		short-term (6 months)
Secondary	correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes		long-term (24 months)
Secondary	correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes		long-term (36 months)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	incidence of immediate provisional implants loss		up to 6 months
Secondary	incidence of definitive implant loss		up to 36 months