Evaluation of Alveolar Augmentation Using Tunneling Surgi... | NCT03498573

Studies
Evaluation of Alveolar Augmentation Using Tunneling Surgical Technique

NCT03498573

Sponsor

Hussien Amer Elkady

Status

Unknown status

Last Update Posted

Apr 13, 2018Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Bone Atrophy

Interventions

tunneling surgical technique

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 2018

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

May 1, 2018Estimated

Primary Completion Date

Jul 2018Estimated

Completion Date

Apr 2019Estimated

First Submitted Date

Mar 29, 2018

First Submission Date that Met QC Criteria

Apr 7, 2018

First Posted Date

Apr 13, 2018Actual

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 7, 2018

Last Update Posted Date

Apr 13, 2018Actual

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

patients suffering from anterior maxillary horizontal bone defect the alveolar ridge will be augmented by minimally invasive tunneling technique utilizing MPM as bone graft and patients followed up for 14 weeks .

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

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tunneling surgical technique	Experimental		Other: tunneling surgical technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tunneling surgical technique	Other	sticky bone prepared by centrifuge patient blood and mixing with xinograft	tunneling surgical technique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
bone formation	bone formation assessed by cone beam ct	14 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients' age range from 18-60 years.
Patients with horizontal bone defect in anterior maxillary area.
Patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome.

Exclusion Criteria:

• Patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders and autoimmune diseases (may affect normal healing).

Accepts Healthy Volunteers

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
hussien amer elkady, B.D.S	Contact	01141178095		elkady_003@yahoo.com
tarek elghareeb	Contact

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19639058	Background	Nevins ML, Camelo M, Nevins M, Schupbach P, Friedland B, Camelo JM, Kim DM. Minimally invasive alveolar ridge augmentation procedure (tunneling technique) using rhPDGF-BB in combination with three matrices: a case series. Int J Periodontics Restorative Dent. 2009 Aug;29(4):371-83.