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

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

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

Study Overview

• Status: Completed
• Conditions: Maxillary Sinus
• Intervention / Treatment: Other: platelet rich fibrin; Other: Polyether ether ketone

Detailed Description

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 ) .

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEEK and PRF; maxillary sinus elevation using PEEK and platelet rich fibrin	Other: platelet rich fibrin; platelet rich fibrin; Other Names: P.R.F; Other: Polyether ether ketone; Polyether ether ketone; Other Names: PEEK
Active Comparator: PEEK alone; maxillary sinus elevation using PEEK alone	Other: Polyether ether ketone; Polyether ether ketone; Other Names: PEEK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone quantity	using of CBCT	6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone quality	Histomorphometic analysis (For Core biopsy)	6 months postoperatively

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: maxillary sinus elevation and PEEK
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Anesthetics, Inhalation; Ether
• Other Study ID Numbers: 3-3-13

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
• product manufactured in and exported from the U.S.: No