Lateral Sinus Augmentation Using L-PRF as Sole Graft Material

Lateral Sinus Augmentation Using L-PRF and Xenograft: Radiographic and Histomorphometry Analysis.

Severe maxillary atrophy occurs after extraction of teeth in poster maxilla due to dimensional changes occur after removal; besides, sinus membrane pneumatization causes alveolar bone resorption, different classification for remaining alveolar bone in the posterior maxilla were done. In this study, the ABC sinus classification was followed in case selection. A sinus augmentation is done with several techniques. Sinus membrane elevation is done with two different approaches, either the crestal approach or lateral window approach.

Using biofiller material for sinus membrane elevation has been tried by many researchers, using a bone graft, platelet concentrates preparation, collagen membranes, tenting screws, or with implant tenting.

In this study, sinus augmentation was performed using a lateral window approach using L-PRF as sole biofiller material in one group, xenograft as only biofiller material in the second group and mixed xenograft with L-PRF in the third group. Histomorphometric analysis was done from the core biopsy after three months of augmentation, and implant placement was done.

After three months, prosthetic parts were placed. The results of this study show that the augmentation of the sinus using L-PRF mixed with bone graft is showing the best results followed by L-PRF only, and the least was xenograft.

From this point of discussion, it can be considered that using L-PRF as sole biofiller material in sinus augmentation.

Study Overview

• Status: Completed
• Conditions: Maxillary Diseases
• Intervention / Treatment: Procedure: L-PRF; Procedure: xenograft; Procedure: L-PRF mixed with xenograft

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adult patients.
2. Both sex, males and females.
3. Age from 24 - 49 years old.
4. All patients were free from any systemic diseases as evidenced by Burkett's oral medicine health history questionnaire.
5. Extraction done at posterior maxilla involved with the maxillary sinus.
6. Remaining alveolar bone ≤ 5mm vertically and ≥ 4mm horizontally and from 1.5 mm to 3.5 mm vertically.
7. Gingival biotype 1-2mm thickness.
8. Patient has no previous surgery in Maxillary antrum.

Exclusion Criteria:

1. Smokers.
2. Pregnant and breast-feeding females.
3. Mentally retarded Patients.
4. Presence of hematologic disease.
5. Previous radiation, chemotherapy, or immunosuppressive treatments.
6. Diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy.
7. Patient with history of chronic sinus pathosis
8. Anticoagulant drugs, Endocarditis risk factors, renal and hepatic failure.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: L-PRF as sole graft material; lateral sinus augmentation using L-PRF as sole graft material	Procedure: L-PRF; sinus augmentation using L-PRf as sole graft material
Experimental: xenograft as sole graft material; lateral sinus augmentation using xenograft as sole graft material	Procedure: xenograft; sinus augmentation using xenograft as sole graft material
Experimental: Xenograft mixed with L-PRF as graft material; lateral sinus augmentation using L-PRF mixed with xenograft as graft material	Procedure: L-PRF mixed with xenograft; sinus augmentation using L-PRF mixed with xenograft as sole graft material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
histomorphometric analysis	After three months from sinus augmentation, a second surgery will be done for implant placement; during this procedure, a bone core biopsy will be harvested. The biopsy will be stained with mason stain for histomorphometric analysis. The aim is to measure the newly formed bone for three months.	3 months

Collaborators and Investigators

• Sponsor: British University In Egypt

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2016
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: September 8, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Jaw Diseases; Maxillary Diseases
• Other Study ID Numbers: 280986

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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