Osseodensification Plus Platelet Rich Fibrin With Simulta... | NCT05797675

Studies
Osseodensification Plus Platelet Rich Fibrin With Simultaneous Implant Installation in Closed Sinus Lift

NCT05797675

Sponsor

Arab American University (Palestine)

Status

Completed

Last Update Posted

Apr 11, 2023Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Oral Sinus

Interventions

prf + osseodensification

Countries

Palestinian Territories

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 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2022Actual

Primary Completion Date

Nov 20, 2022Actual

Completion Date

Dec 30, 2022Actual

First Submitted Date

Mar 22, 2023

First Submission Date that Met QC Criteria

Mar 22, 2023

First Posted Date

Apr 4, 2023Actual

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 9, 2023

Last Update Posted Date

Apr 11, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

hadeel bassam albahar, dr, Arab American University (Palestine)Principal Investigator

Lead Sponsor

Arab American University (Palestine)OTHER

Collaborators

Not provided

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

12 patients with indirect sinus lift will be selected with RBH>5mm , surgical procedure

=osseodensification + Prf+ implant .

versah drilling system (osseodensefication technique )will be used , moreover Prf will be prepared by Blood collected in PRF tubes from patients then centrifuge (1300rpm ,14min ) .
primary stability will be measured using Resonance Frequency Analysis by Osstellimmediately and after 6 Mn .
CBCT will be taken before surgery , perioapical x-ray immediately after surgery and CBCT at 6m follow up to be apple to see the differences regarding bone quality and volume.

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

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test group	Experimental	Implant therapy and closed sinus lifting with A-PRF	Procedure: prf + osseodensification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
prf + osseodensification	Procedure	prf+ osseodensification in close sinus lift	Test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
secondary stability of implant	by osstel	6 months
bone density	measuring and evaluating bone density by cbct	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- medically fit non pregnant no sinus pathology

Exclusion Criteria:

young patients under 18
sinus pathology

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
hadeel albahar, master	Arab American University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadeel Albahar		Nablus			Palestinian Territories

Intervention Browse Module

MeSH Terms

ID	Term
D056690	Prolactin-Releasing Hormone

Ancestor Terms

ID	Term
D007028	Hypothalamic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

Not provided