Titanium Prepared Platelet-rich Fibrin in Bone Regeneration in Lateral Window Maxillary Sinus Augmentation

Evaluation of Titanium-prepared Platelet-rich Fibrin in Bone Regeneration in Lateral Window Maxillary Sinus Augmentation (Clinical Trial)

This trial aims to evaluate the effect of the sole use of T-PRF in bone formation process as applied in maxillary sinus floor elevation in comparison to traditional T-PRF/bone graft combination.

This study is clinical trial that will include 18 patients seeking implant placement in upper posterior maxilla compromised with maxillary sinus pneumatization. Patients will be assigned into control and test groups. All the patients will undergo sinus lifting procedure through which a combination of xenograft and T-PRF was used in the control group whereas; sole T-PRF will be applied in the test group.

Study Overview

• Status: Completed
• Conditions: Sinus Lifting
• Intervention / Treatment: Other: T-PRF alone; Other: T-PRF/Xenograft

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Systemically in a healthy condition.
• Residual bone height is ≤5mm in the posterior maxilla as measured with CBCT.
• Non-smokers.
• Good oral hygiene as indicated by plaque and bleeding scores

Exclusion Criteria:

• Medically compromised conditions will be excluded to avoid infections or any adverse reaction related to immunity suppression.
• Acute maxillary sinusitis.
• Patients administering any antibiotics or regular anti-inflammatory drugs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T-PRF	Other: T-PRF alone; T-PRF is the material to be tested in this study as an alternative to classical bone graft
Active Comparator: T-PRF/xenograft	Other: T-PRF/Xenograft; One part of T-PRF will be divided into minute pieces to be mixed with xenograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain level	measuring level of pain using visual analog scale (VAS) 0-10, where 0 reading indicates no pain and 10 reading reflects the most severe pain.	up to 2 weeks
Change in bone volume	pre opertaive and post operative CBCT	up to 3 months
Change in bone denisty	pre opertaive and post operative CBCT	up to 3 months
Change in bone height	pre opertaive and post operative CBCT	up to 3 months

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Actual): March 21, 2023
• Study Completion (Actual): March 21, 2023

Study Registration Dates

• First Submitted: November 11, 2023
• First Submitted That Met QC Criteria: November 11, 2023
• First Posted (Estimated): November 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 11, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 0301_10/2021

Drug and device information, study documents

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