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

Maxillary Sinus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06376708
• Other study ID #: 3-3-13
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 ) .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Maxillary Sinus

Intervention

Other:
• platelet rich fibrin
platelet rich fibrin
• Polyether ether ketone
Polyether ether ketone

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone quantity	using of CBCT	6 months postoperatively
Secondary	Bone quality	Histomorphometic analysis (For Core biopsy)	6 months postoperatively