Severely Atrophic JawVOLCRANNCT02810184
Determination of Bone Volume Changes of the Cranial Bone-augmented Jaw: A Feasibility Study
An observational study of Severely Atrophic Jaw, run by AZ Sint-Jan AV at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severely Atrophic Jaw
- What is being tested?
- cone-beam computed tomography (CBCT)
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2016to Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV
Bruges
About this study
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.
Read the 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.
- Conditions
- Severely Atrophic Jaw
- Being tested
- cone-beam computed tomography (CBCT)
- Keywords
- bone augmentation, long-term bone volume changes, immediate provisional implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cone-beam computed tomography (CBCT)Radiation
additional CBCT scan at 24 and 36 months, for analysis of evolution of bone volume
| Study group | Role | What they receive |
|---|---|---|
| CBCT arm | all participating patients receive an additional CBCT scan at 24 and 36 months, for analysis of evolution of bone volume Receives: Radiation: cone-beam computed tomography (CBCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean total bone volume changes (%)
Measured: 6, 24, and 36 months post surgery
Secondary outcomes (8)
correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes
Measured: short-term (6 months)
correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes
Measured: long-term (24 months)
correlation between biologic risk factors, as collected through medical files and patient interview, with undesirable bone volume changes
Measured: 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
Measured: 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
Measured: 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
Measured: long-term (36 months)
incidence of immediate provisional implants loss
Measured: up to 6 months
incidence of definitive implant loss
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2022 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severely Atrophic JawStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Abeloos, AZ Sint-Jan AV
- Investigators
- Johan Abeloos, MD, PhD, Principal investigator, Head of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810184
- Sponsor's protocol ID
- B049201627591
- Acronym
- VOLCRAN
- Status last verified
- Feb 2022
- First submitted
- 13 Jun 2016
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Bone Volume Changes of the Cranial Bone-augmented Jaw: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02810184
- Acronym / sponsor ID
- VOLCRAN / B049201627591
- Conditions
- Severely Atrophic Jaw
- Keywords
- bone augmentation, long-term bone volume changes, immediate provisional implant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBCT arm | – | Radiation: cone-beam computed tomography (CBCT)all participating patients receive an additional CBCT scan at 24 and 36 months, for analysis of evolution of bone volume |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cone-beam computed tomography (CBCT)additional CBCT scan at 24 and 36 months, for analysis of evolution of bone volume | Radiation | CBCT arm |
Primary outcome
mean total bone volume changes (%)
Time frame: 6, 24, and 36 months post surgery
8 secondary outcomes
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
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Abeloos, MD, PhD principal investigator
Head of Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severely Atrophic Jaw, run by AZ Sint-Jan AV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean total bone volume changes (%) (time frame: 6, 24, and 36 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.