Horizontal Ridge Augmentation of the Mandible Autogenous... | NCT03183336

Studies
Horizontal Ridge Augmentation of the Mandible Autogenous Block Grafts

NCT03183336

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jul 11, 2017Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Horizontal Ridge Deficiency
Block Graft

Interventions

ridge split interpositional block graft
decortication Onlay block graft

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

Jul 2017

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

Jul 2016Actual

Primary Completion Date

Aug 2017Estimated

Completion Date

Sep 2017Estimated

First Submitted Date

Jun 6, 2017

First Submission Date that Met QC Criteria

Jun 8, 2017

First Posted Date

Jun 12, 2017Actual

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

Jul 6, 2017

Last Update Posted Date

Jul 11, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

20 subjects presenting with horizontal mandibular ridge width less than 5 mm were selected and randomly divided two groups (10 in each group). the first group received interpositional block grafts (harvested from the chin and ramus) covered with Platelet-rich fibrin membrane. the second group received onlay block grafts (harvested from the chin and ramus) and covered with Platelet-rich fibrin membrane. the grafts are left for 4 months. the alveolar ridge width dimensions is then measured using radiographic analysis using cone-beam computed tomography scans

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interpositional block graft	Experimental	ridge split interpositional block graft	Procedure: ridge split interpositional block graft
Onlay block graft	Active Comparator	decortication onlay block graft	Procedure: decortication Onlay block graft

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ridge split interpositional block graft	Procedure		Interpositional block graft
decortication Onlay block graft

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
alveolar ridge width gained	radiographic analysis following ridge augmentation using Cone beam computed tomography	4 months

Secondary Outcomes

Measure	Description	Time Frame
patient morbidity following the surgical procedure	pain value on pain scale	14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients of both sexes with a minimum vertical bone height above the inferior alveolar canal of 10mm in the edentulous region.

Patients should have ridge thickness less than 5mm measured 2mm from the alveolar crest Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.

Exclusion Criteria:

Patients with any systemic disease that may affect normal bone healing. Patients with drug allergies, drug or alcohol abuse, periodontal diseases or poor oral hygiene

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided