Lateral Sinus Augmentation Using L-PRF as Sole Graft Material

NCT04160780 | Completed DMC

• 1 other identifier: 280986
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Maxillary Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

L-PRF as sole graft material

EXPERIMENTAL

lateral sinus augmentation using L-PRF as sole graft material

Procedure: L-PRF

xenograft as sole graft material

EXPERIMENTAL

lateral sinus augmentation using xenograft as sole graft material

Procedure: xenograft

Xenograft mixed with L-PRF as graft material

EXPERIMENTAL

lateral sinus augmentation using L-PRF mixed with xenograft as graft material

Procedure: L-PRF mixed with xenograft

Interventions

L-PRF PROCEDURE

sinus augmentation using L-PRf as sole graft material

L-PRF as sole graft material

L-PRF mixed with xenograft PROCEDURE

sinus augmentation using L-PRF mixed with xenograft as sole graft material

Xenograft mixed with L-PRF as graft material

xenograft PROCEDURE

sinus augmentation using xenograft as sole graft material

xenograft as sole graft material

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• British University In Egypt: lead

MeSH Terms

Conditions

Maxillary Diseases

Interventions

Transplantation, Heterologous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: September 8, 2019
• First Posted: November 13, 2019
• Study Start: March 26, 2016
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: December 5, 2019

Record last verified: 2019-12