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

Not Applicable

Completed

• Conditions: Maxillary Sinus
• Interventions: Other: platelet rich fibrin; Other: Polyether ether ketone

• Registration Number: NCT06376708
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study Start: 2022-09-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-07-01
• Status Verified: 2023-09
• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-04-17
• Last Update Submitted: 2024-04-17
• Study First Posted: 2024-04-19
• Last Update Posted: 2024-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEEK and PRF	platelet rich fibrin	maxillary sinus elevation using PEEK and platelet rich fibrin
PEEK alone	Polyether ether ketone	maxillary sinus elevation using PEEK alone
PEEK and PRF	Polyether ether ketone	maxillary sinus elevation using PEEK and platelet rich fibrin

Primary Outcome Measures

Name	Time	Method
Bone quantity	6 months postoperatively	using of CBCT

Secondary Outcome Measures

Name	Time	Method
Bone quality	6 months postoperatively	Histomorphometic analysis (For Core biopsy)

Trial Locations

Locations (1)

Faculty of Dentistry Cairo University; 🇪🇬 Cairo, Egypt