Comparison Between PEEK With Autogenous Bone Graft and PEEK With Xenograft in Maxillary Sinus Augmentation

November 16, 2024 updated by: mohamed gamal hammad, Cairo University

Comparison Between PEEK With Autogenous Bone Graft and PEEK With Xenograft in Maxillary Sinus Augmentation: Clinical, Radiographic and Histomorphometric Analysis. Randomized Clinical Trials.

Comparison Between PEEK With Autogenous Bone Graft and PEEK With Xenograft in Maxillary Sinus Augmentation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Comparison Between PEEK With Autogenous Bone Graft and PEEK With Xenograft in Maxillary Sinus Augmentation: clinical, radiographic and histomorphometric analysis .

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

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

  • Egypt
      • Cairo, Egypt, 14444
        • Faculty of Dentistry Cairo University

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • posterior edentulous ridge less than 4mm in bone height

Exclusion Criteria:

  • insufficient oral hygiene and motivation

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEEK With Autogenous Bone Graft
maxillary sinus elevation using PEEK device and placement of autogenous bone graft
Other: PEEK With Autogenous Bone Graft
placement of PEEK With Autogenous Bone Graft
Experimental: PEEK With Xenograft
maxillary sinus elevation using PEEK device and placement of xenograft
Other: PEEK With Xenograft
placement of PEEK With xenograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone height
Time Frame: after 6 months
using CBCT in mm
after 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone quality
Time Frame: after 6 months
core biopsy (Histomorphometric evaluation)
after 6 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 (Actual)

June 1, 2023

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

July 23, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 16, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 33-6-23

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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