Lateral Sinus Augmentation Using L-PRF as Sole Graft Material

Maxillary Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04160780
• Other study ID #: 280986
• Status: Completed
• Phase: N/A
• Start date: March 26, 2016
• Est. completion date: April 1, 2019

Study information

• Verified date: December 2019
• Source: British University In Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Maxillary Diseases

Intervention

Procedure:
• L-PRF
sinus augmentation using L-PRf as sole graft material
• L-PRF mixed with xenograft
sinus augmentation using L-PRF mixed with xenograft as sole graft material
• xenograft
sinus augmentation using xenograft as sole graft material

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
British University In Egypt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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