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

NCT06376708 | Completed

• 1 other identifier: 3-3-13
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Maxillary Sinus

Keywords

maxillary sinus elevation and PEEK

Outcome Measures

Primary Outcomes (1)

• Bone quantity

  using of CBCT

  6 months postoperatively

Secondary Outcomes (1)

• Bone quality

  6 months postoperatively

Study Arms (2)

PEEK and PRF

EXPERIMENTAL

maxillary sinus elevation using PEEK and platelet rich fibrin

Other: platelet rich fibrin; Other: Polyether ether ketone

PEEK alone

ACTIVE COMPARATOR

maxillary sinus elevation using PEEK alone

Other: Polyether ether ketone

Interventions

platelet rich fibrin OTHER

platelet rich fibrin

Also known as: P.R.F

PEEK and PRF

Polyether ether ketone OTHER

Polyether ether ketone

Also known as: PEEK

PEEK alone; PEEK and PRF

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

polyetheretherketone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master holder

Model Details: use of platelet rich fibrin after maxillary sinus elevation using PEEK

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 19, 2024
• Study Start: September 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: July 1, 2023
• Last Updated: April 19, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)