The Use of Extended Platelet Rich Fibrin in Lateral Sinus Augmentation

Extended Platelet Rich Fibrin in Lateral Maxillary Sinus Lifting With Simultaneous Implant Placement.

thirty implants will be inserted in patients seeking implantation of their lost posterior maxillary teeth (premolar and molars) with limited bone height below the floor of the maxillary sinus, secondary to sinus pneumatization. The patients will be selected from those attending the outpatient clinic of the Oral & Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.

1. Clinical Evaluation

   • Implant stability

2. Radiographic Evaluation Vertical bone gain (VBG)

Study Overview

• Status: Not yet recruiting
• Conditions: Sinus Lift Augmentation
• Intervention / Treatment: Procedure: lateral sinus lift with using allograft and collagen membrane; Procedure: lateral sinus lift with using exteneded platelet rich fibrin

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ammar samman; Phone Number: +201558990325; Email: dr.3mmar@std.mans.edu.eg

Study Locations

• Egypt
  • Mansoura, Egypt
    • Mansoura University
    • Contact: mansoura

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patent ostium of maxillary sinus.
• Patient with missing one or more posterior maxillary teeth.
• Residual bone height of 3-6 mm, measured from the crest of alveolar ridge to the floor of the maxillary sinus at the planned implant site.
• A ridge width at the site of implantation of <5mm.
• Platelets of normal range.
• Good oral hygiene.
• Patients in the age frame between 20 years and 60 years old.
• No gender preface in selection of the patients.
• A minimum crown height space of 8 mm.

Exclusion Criteria:

• Active sinusitis, cyst, tumors or root tips at the planned surgical site.
• Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
• Heavy smoking and alcoholism.
• Parafunctional habits such as bruxism and clenching.
• Signs of acute infection or pus discharge.
• Disturbed occlusion.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lateral sinus lift with bone augmenation	Procedure: lateral sinus lift with using allograft and collagen membrane; sinus floor elevation with placing allograft and collagen membrane
Experimental: lateral sinus lift with extended platelet rich fibrin	Procedure: lateral sinus lift with using exteneded platelet rich fibrin; sinus floor elevation with placing eprf

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
implant stability	the stability of the implants will be evaluated by RFA with the Osstell Mentor device.	9 months
Vertical bone height	vertical bone height will be measured as the distance from the alveolar crest to the new sinus floor at the middle of the implant	6 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: A0102024OS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No