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Completed

NCT Number: NCT06376708

Comparison Between PEEK With Platelet-rich Fibrin and PEEK Alone in Maxillary Sinus Augmentation

comparison between the resulted bone during maxillary sinus elevation by PEEK with and without platelet rich fibrin

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Key information

Conditions

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Cairo University

Cairo, Egypt

About this study

Histomorphometric and clinical analysis of the bone formed after 6 months after the maxillary sinus elevation using PEEK in the 2 groups : the study group (PEEK with platelet rich fibrin) and the control group (PEEK alone ) .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Posterior edentulous ridges with pneumatized maxillary sinus and remaining bone height less than 4 mm.
  • ASA physical status I and II.
  • Patients willing to be a part of the study and ready to give their consent in writing for the same.
  • Patient not complain from maxillary sinusitis
  • Patient with good oral hygiene.
  • Both males as well as females without any active periodontal disease.
  • The edentulous ridges are covered with optimal thickness of mucoperiosteum with no signs of inflammation, ulceration or scar tissue.
  • Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.

Exclusion criteria

  • • General contraindications to implant surgery.
  • Untreated gingivitis, periodontitis.
  • Subjected to irradiation in the head and neck area less than 1 year before implantation.
  • Untreated periodontitis.
  • Pregnant or nursing.
  • Unable to open mouth sufficiently to accommodate the surgical tooling.
  • Patients participating in other studies, if the present protocol could not be properly followed.
  • Patient who could/would not participate in the follow-up period.

Treatment and study plan

platelet rich fibrin

Other

platelet rich fibrin

Other names: P.R.F

Polyether ether ketone

Other

Polyether ether ketone

Other names: PEEK

Primary outcomes

  1. Bone quantity

    Time frame: 6 months postoperatively

    using of CBCT

Secondary outcomes

  1. Bone quality

    Time frame: 6 months postoperatively

    Histomorphometic analysis (For Core biopsy)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparison Between PEEK With Platelet-rich Fibrin and PEEK Alone in Maxillary Sinus Augmentation: Histomorphometric and Clinical Analysis: A Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2024
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.