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

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ClinicalTrials.gov Identifier: NCT02810184
Recruitment Status : Recruiting
First Posted : June 22, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Johan Abeloos, AZ Sint-Jan AV

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Severely Atrophic Jaw Radiation: cone-beam computed tomography (CBCT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Determination of Bone Volume Changes of the Cranial Bone-augmented Jaw: A Feasibility Study
Study Start Date : June 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : July 2023

Arm 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




Primary Outcome Measures :
  1. mean total bone volume changes (%) [ Time Frame: 6, 24, and 36 months post surgery ]

Secondary Outcome Measures :
  1. correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes [ Time Frame: short-term (6 months) ]
  2. correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes [ Time Frame: long-term (24 months) ]
  3. correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes [ Time Frame: long-term (36 months) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. incidence of immediate provisional implants loss [ Time Frame: up to 6 months ]
  8. incidence of definitive implant loss [ Time Frame: up to 36 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810184


Contacts
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Contact: Lies Pottel lies.pottel@azsintjan.be

Locations
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Belgium
Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV Recruiting
Bruges, Belgium
Contact: Lies Pottel         
Sponsors and Collaborators
AZ Sint-Jan AV
Investigators
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Principal Investigator: Johan Abeloos, MD, PhD Head of Department
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Responsible Party: Johan Abeloos, Head of department, Division of Maxillofacial surgery, AZ Sint-Jan AV
ClinicalTrials.gov Identifier: NCT02810184    
Other Study ID Numbers: B049201627591
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Johan Abeloos, AZ Sint-Jan AV:
bone augmentation
long-term bone volume changes
immediate provisional implant
Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical