PRF Versus Advanced PRF in Sinus Augmentation

December 12, 2021 updated by: Mahinour magdy mohamed, Cairo University

Platelet Rich Fibrin Versus Advanced Platelet Rich Fibrin as Bone Graft Material in Sinus Augmentation (Randomized Controlled Clinical Trial)

In the present study the main hypothesis , Advanced PRF will improve the bone quality and quantity in sinus augmentation

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Study arm
Patients will undergo sinus augmentation with advanced PRF
Biological: Advanced PRF
Advanced PRF will be placed for patients undergoing sinus augmentation
PLACEBO_COMPARATOR: Controlled arm
Patients will undergo sinus augmentation with PRF
Biological: Control
PRF will be placed for patients undergoing sinus augmentation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 30, 2022

Primary Completion (ANTICIPATED)

August 1, 2022

Study Completion (ANTICIPATED)

September 1, 2022

Study Registration Dates

First Submitted

November 15, 2021

First Submitted That Met QC Criteria

November 15, 2021

First Posted (ACTUAL)

November 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 23, 2021

Last Update Submitted That Met QC Criteria

December 12, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PRF and sinus augmentation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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