Determination of Bone Volume Changes of the Cranial Bone-... | NCT02810184

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

NCT02810184

Sponsor

AZ Sint-Jan AV

Status

Unknown status

Last Update Posted

Feb 28, 2022Actual

Enrollment

16Actual

Phase

Not provided

Conditions

Severely Atrophic Jaw

Interventions

cone-beam computed tomography (CBCT)

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Dec 2022Estimated

Completion Date

Jul 2023Estimated

First Submitted Date

Jun 13, 2016

First Submission Date that Met QC Criteria

Jun 21, 2016

First Posted Date

Jun 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2022

Last Update Posted Date

Feb 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cone-beam computed tomography (CBCT)	Radiation	additional CBCT scan at 24 and 36 months, for analysis of evolution of bone volume	CBCT arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johan Abeloos, MD, PhD	Head of Department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV		Bruges			Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided