Posterior Maxillary Ridge Augmentation With Sinus Lift Us... | NCT03014388

Studies
Posterior Maxillary Ridge Augmentation With Sinus Lift Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft

NCT03014388

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jan 9, 2017Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Bone Resorption

Interventions

autogenous bone
Mineralized plasmatic matrix

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

Dec 2016

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

Jan 2017

Primary Completion Date

Sep 2017Estimated

Completion Date

Oct 2017Estimated

First Submitted Date

Jan 5, 2017

First Submission Date that Met QC Criteria

Jan 5, 2017

First Posted Date

Jan 9, 2017Estimated

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

Jan 5, 2017

Last Update Posted Date

Jan 9, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Refaat Ragab Abu Ellill, Dentist at menistry of health, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Using growth factors obtained from patient's venous blood mixed with particulate autogenous bone the study compares bone gain by implant with gold standards in sinus Lift procedures for future implant insertion.

Detailed Description

To study the effectiveness of MPM in ridge augmentation with implant insertion compared with autogenous bone graft.

-PICO Population(P) : Patients with defective posterior maxillary alveolar ridge. Intervention (I) :Implant placement and ridge augmentation with MPM. Comparator (C) : Autogenous bone graft. Outcome (O) : Patient satisfaction - Implant stability.

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
Autogenous bone graft (Gold Standard).	Experimental	Patients with defective posterior maxillary alveolar ridges requiring implant insertion will have Autogenous bone graft (Gold standard) and to be used for bone augmentation with sinus lift.	Other: autogenous bone
Mineralized Plasmatic Matrix (MPM)	Experimental	Patients with defective posterior maxillary alveolar ridges requiring implant insertion will receive bone graft using Mineralized plasmatic matrix.	Other: Mineralized plasmatic matrix

Interventions

Name	Type	Description	Arm Group Labels	Other Names
autogenous bone	Other	Autogenous bone graft (gold standard). sinus lift with autogenous bone.	Autogenous bone graft (Gold Standard).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient Satisfaction regarding aesthetic results will be measured using questionnaire.	outcome will be measure using questionnaire.	9 months

Secondary Outcomes

Measure	Description	Time Frame
Stability of dental implants.	will be measured using OSTELL Device.	5 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients systemically free.
Patients with posterior maxillary defective ridges indicated for sinus lift procedure.
Cases with 5 mm bone height or less are included in the study.
Age between 18 and 50 years.
Both sexes.
Patients physically able to tolerate surgical and restorative procedures.
Good oral hygiene.
Highly motivated patients.

Exclusion Criteria:

Patients allergic to local anesthetic agent.
Medium and heavy smokers.
Pregnant females.
Presence of any pathosis in the pre-implant site.
Presence of any mucosal disease.
History of oral radiotherapy.
History of prolonged steroids use.
Psychological disorders.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
refaat ragab, Master	Contact	01111175536		refaat.ragab.rr@gmail.com

Overall Officials

Name	Affiliation	Role
Cairo University CBE	Cairo University - Ethics Committee.	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Evaluation of the comparative Effectiveness of MPM Augmentation in posterior maxillary ridge defects with Autogenous bone graft.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001862	Bone Resorption

Ancestor Terms

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided