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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06376708
Other study ID # 3-3-13
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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