PRF Versus Advanced PRF in Sinus Augmentation | NCT05134753

Studies
PRF Versus Advanced PRF in Sinus Augmentation

NCT05134753

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Dec 23, 2021Actual

Enrollment

32Estimated

Phase

Phase 3

Conditions

Maxillary Sinus

Interventions

Advanced PRF
Control

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 2021

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 30, 2022Estimated

Primary Completion Date

Aug 1, 2022Estimated

Completion Date

Sep 1, 2022Estimated

First Submitted Date

Nov 15, 2021

First Submission Date that Met QC Criteria

Nov 15, 2021

First Posted Date

Nov 26, 2021Actual

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

Dec 12, 2021

Last Update Posted Date

Dec 23, 2021Actual

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

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study arm	Experimental	Patients will undergo sinus augmentation with advanced PRF	Biological: Advanced PRF
Controlled arm	Placebo Comparator	Patients will undergo sinus augmentation with PRF	Biological: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Advanced PRF	Biological	Advanced PRF will be placed for patients undergoing sinus augmentation	Study arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bone quality	Histological analysis for core biopsies Available bone quality will be evaluated by measuring the Total Bone Volume (TBV)	Six months

Secondary Outcomes

Measure	Description	Time Frame
Bone quantity	• Linear height measurements changes of the bone will be evaluated via panoramic X-rays	Six months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The Patients with missing posterior maxillary teeth with insufficient available bone for implant placement indicating the need for maxillary sinus floor augmentation before implantation.

2. The Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.

3. The Patients should be free from any sinus disease that might affect the health and integrity of the sinus lining.

4. Assign an informed consent to be involved in the study.

Exclusion Criteria:

Patients with any systemic disease that may affect normal healing. 2. Patients with any sinus disease.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Mahinour Magdy Mohamed	Contact	01223944859	02	Mahinour_mohamed@dentistry.cu.edu.eg

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided