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

Osseodensification Plus Platelet Rich Fibrin With Simultaneous Implant Installation in Closed Sinus Lift : A Randomized Control Trial.

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

=osseodensification + Prf+ implant .

1. 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 ) .
2. primary stability will be measured using Resonance Frequency Analysis by Osstellimmediately and after 6 Mn .
3. 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.

Study Overview

• Status: Completed
• Conditions: Oral Sinus
• Intervention / Treatment: Procedure: prf + osseodensification

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Palestinian Territory, occupied
  • Nablus, Palestinian Territory, occupied
    • Hadeel Albahar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- medically fit non pregnant no sinus pathology

Exclusion Criteria:

• young patients under 18
• sinus pathology

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; Implant therapy and closed sinus lifting with A-PRF	Procedure: prf + osseodensification; prf+ osseodensification in close sinus lift; Other Names: platelet concentrates,

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Arab American University (Palestine)
• Investigators: Principal Investigator: hadeel albahar, master, Arab American University

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2022
• Primary Completion (Actual): November 20, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 9, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: AAUP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No