Modified Surgical Technique for Lateral Block Augmentatio... | NCT05339971

Studies
Modified Surgical Technique for Lateral Block Augmentation Prior to Implant Installation

NCT05339971

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Apr 21, 2022Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Bone Augmentation

Interventions

block perforation

Countries

Not provided

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

Apr 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

Dec 7, 2016Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Apr 9, 2022

First Submission Date that Met QC Criteria

Apr 15, 2022

First Posted Date

Apr 21, 2022Actual

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

Apr 15, 2022

Last Update Posted Date

Apr 21, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kristina Bertl, Principal Investigator, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Evaluation of the surgical result (augmentation volume, proportion of newly formed bone) after perforation of the bone block in the course of lateral block augmentation prior to planned implant installation.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
block perforation	Experimental		Other: block perforation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
block perforation	Other	The bone block used for lateral bone augmentation will be perforated several times.	block perforation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Histomorphometry	% of new bone formation	at implant installation (approximately 6 months after augmentation)
Radiographic	Volume gain (mm3) after block augmentation at the buccal aspect	6 months after block augmentation
Radiographic	Volume gain (mm3) after block augmentation at the buccal aspect	12 months after block augmentation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

single tooth gap in need of lateral bone augmentation prior to implant installation

Exclusion Criteria:

untreated periodontal disease
systemic disease and/or medication intake with significant effect on bone healing

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

130 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided