Crestal Bone Level After Allogenic Bone Ring With Simulta... | NCT03906591

Studies
Crestal Bone Level After Allogenic Bone Ring With Simultaneous Dental Implant Placement

NCT03906591

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Apr 8, 2019Actual

Enrollment

28Estimated

Phase

Not Applicable

Conditions

Allogenic Bone Ring

Interventions

allogenic bone ring
autogenous bone ring

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 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2019Estimated

Primary Completion Date

Oct 2022Estimated

Completion Date

Feb 2023Estimated

First Submitted Date

Apr 4, 2019

First Submission Date that Met QC Criteria

Apr 4, 2019

First Posted Date

Apr 8, 2019Actual

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 4, 2019

Last Update Posted Date

Apr 8, 2019Actual

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

This trial is aiming to answer a question whether in Patients with severely atrophied, distal mandibular regions, the use of allogenic bone rings with simultaneous dental implants, compared to autogenous bone rings, give successful clinical and radiographic outcomes without donor site morbidity

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

28Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
allogenic bone ring	Experimental		Procedure: allogenic bone ring
autogenous bone ring	Active Comparator		Procedure: autogenous bone ring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
allogenic bone ring	Procedure	allogenic bone ring with simultaneous dental implant placement	allogenic bone ring

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in crestal bone height	cone beam computed tomography will be used to measure bone height in millimeters	at 6 months

Secondary Outcomes

Measure	Description	Time Frame
graft failure	signs of graft failure will be evaluated by clinical examination	after 1 week, 6 months and after 9 months
implant loss	signs of implant loss will be evaluated by clinical examination

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Medically free form any systemic diseases that contraindicate the surgical procedures or affect predictable outcomes and non-smoker subjects.
Atrophic mandibular distal region requiring vertical augmentation.
Good oral hygiene and healthy keratinized mucosa.

Exclusion Criteria:

Presence of acute dentoalveolar infection or any pathologic lesions.
Totally edentulous patients and patients requiring massive reconstruction and augmentation procedures.
Patients with history of previously failed augmentation procedures, or failed implant placement at the intended augmentation region.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
alaa ragab, master	Contact	00201224665688		dralaa3@hotmail.com
Sherif Aly, PhD	Contact	00201001932020		Sherief.ali@hotmail.com

Overall Officials

Not provided

Locations

Not provided