Biphasic Material With PRF in Lateral Sinus Floor Augmentation

The Lateral Approach Maxillary Sinus Floor Augmentation Using Biphasic Material Combined With Injectable Platelet Rich Fibrin- Randomized Clinical Trial

A lack of bone in the posterior maxilla, mainly resulting from the combination of alveolar bone resorption after tooth loss, pneumatization of the maxillary sinus, and periodontal disease, leads to increased difficulty during dental implant treatment.

The classic technique for maxillary sinus floor augmentation entails the preparation of the trap door to elevate the schneiderian membrane in the lateral sinus wall. it can be done either in a single stage with simultaneous implant placement or in two stages with delayed implant placement, depending on the available residual alveolar ridge height that necessary for implant primary stability.

The new compartment created between the floor of maxillary sinus and the elevated membrane was filled with either autogenous, allografts, xenograft or combination of them to maintain space for new bone formation. The disadvantages of such methods are high costs for grafting material, time consuming and high morbidity, because harvesting of bone grafts is needed.

Study Overview

• Status: Not yet recruiting
• Conditions: Maxillary Sinus Disease
• Intervention / Treatment: Procedure: Lateral sinus floor augmentation; Drug: Biphasic Calcium Phosphate; Procedure: Injectable platlets rich fibrin

Detailed Description

Recently, a systematic review demonstrated the effectiveness of synthetic bone materials, including biphasic calcium phosphate (BCP), as substitutes for autogenous bone. BCP consists of hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP). In contrast with stable HA, β-TCP is highly resorptive and is replaced by newly formed bone; therefore, the resorption rate of BCP could be influenced by the ratio of HA and β-TCP.

platelet-rich fibrin (PRF) was recently introduced as additional or replacement materials in bone augmentation procedures. The use of biologic mediators with osteoinductive properties has been considered to reduce the time interval and accelerate the formation of new bone. The strengths of PRF in reducing tissue inflammation, promoting the vascularization of bone tissue, accelerating new bone formation, and improving scaffold mechanics have been reported.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Alzahraa Alghriany, Lecturer; Phone Number: +201203770058; Email: alghriany@aun.edu.eg
• Study Contact Backup: Name: Ahmed Mortada Fikry, Associate professor; Phone Number: +201005432223; Email: mortadafikry@hotmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Residual bone crest height < 5 mm and width≥6 mm in the planned implant site.
• Healed bone crest (at least 6 months elapsed from tooth loss/extraction);

Exclusion Criteria:

• Absolute medical contraindications to implant surgery such as uncontrolled diabetes mellitus, blood platelet disorders, serious osseous disorders, and cardiac arrhythmia; history of bone grafting in the posterior maxilla, immunocompromised patients, taking corticosteroids, taking aspirin before the procedure, positive history of chemotherapy and radiotherapy, and maxillary sinus pathologies

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 BCP alone; Lateral bone augmentation with biphasic calcium phosphate BCP bone substitute application	Procedure: Lateral sinus floor augmentation; maxillary sinus floor augmentation by lateral approach; Drug: Biphasic Calcium Phosphate; appliaction of BCP bone substitute
Active Comparator: Group 2 BCP with I-PRF; Lateral bone augmentation with biphasic calcium phosphate BCP bone substitute application with addition of injectable platlet rich fibrin I-PRF	Procedure: Lateral sinus floor augmentation; maxillary sinus floor augmentation by lateral approach; Drug: Biphasic Calcium Phosphate; appliaction of BCP bone substitute; Procedure: Injectable platlets rich fibrin; centrifuge 10 ml of patient blood to get I-PRF that applied to the bone substitute

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertical bone gain BG	Vertical bone gain (BG) 6 months after sinus augmentation in both height and density aspects by cone beam CT	6 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2024
• Primary Completion (Estimated): March 15, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: October 1, 2023
• First Submitted That Met QC Criteria: October 1, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: PRF; sinus floor augmentation; biphasic calcium phosphate
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Paranasal Sinus Diseases; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: PRF in sinus augmentation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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