Lateral Sinus Augmentation Utilizing Bovine Bone Mixed with Platelet-rich Fibrin

February 1, 2025 updated by: NIBRAS HAMDAN CHASIB BAIDHANI, University of Baghdad

Lateral Sinus Augmentation Utilizing Bovine Bone Mixed with Platelet-rich Fibrin: Evaluation of Graft Volume Changes Based on CBCT Imaging

Background:

In sinus augmentation procedure, graft resorption remains a major dilemma of various graft materials.

Objective:

To estimate the graft volume changes following lateral sinus augmentation utilizing cone beam computed tomography.

Methods: A total of 34 lateral sinus augmentation operations were performed and 50 dental implants were concomitantly inserted. The sinus augmentation cases were distributed randomly into 3 groups according to graft material: Group A comprised utilizing deproteinized bovine bone alone, group B using deproteinized bovine bone mixed with leukocyte and platelet-rich fibrin, and group C employing deproteinized bovine bone mixed with advanced platelet-rich fibrin. Cone-beam computed tomography was obtained 2 weeks (baseline record) and 24 weeks postoperatively for the measurement of the graft volume changes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Early Phase 1

Contacts and Locations

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

Study Locations

  • Iraq
    • Baghdad
      • Bab Al Muadham, Baghdad, Iraq, 10047
        • College of Dentistry

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • requiring lateral sinus lift for implant placement

Exclusion Criteria:

  • available bone permits implant placement without need for sinus lifting

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: utilizing bovine bone mixed with PRF for sinus lifting
Procedure: lateral sinus lift

A rectangular shaped osteotomy was performed using a low-speed surgical handpiece and round diamond bur, with copious cooled normal saline irrigation.

The Schneiderian membrane (SM) was gently elevatated using Frios Sinus Set elevators for implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of graft volume changes based on CBCT imaging
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

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

Sponsor

University of Baghdad

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 (Actual)

January 13, 2023

Primary Completion (Actual)

March 20, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

February 1, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 1, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 998125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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