Comparison of the Use of Bovine Bone Graft and Titanium-Platelet Rich Fibrin in Maxillary Sinus Augmentation

NCT05596084 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-01-30

No results posted yet for this study

Summary

Before placement of the dental implant in the posterior maxilla where the maxillary sinus is pneumatized, it is necessary to elevate of the sinus mucosa from the sinus floor (sinus lift) and to provide new bone formation by using bone-forming graft materials (maxillary sinus augmentation) in the space obtained. In the bilateral maxillary posterior region with insufficient bone height with tooth deficiency, two-stage sinus lift and placement of platelet-rich fibrin prepared with titanium on one side and bovine bone graft on the other side in the implant surgery will affect the primary stability of the implant, the obtained bone histology, volume, height and density is the evaluation of its effect on it. Ten patients who required a maxillary sinus augmentation procedure for implant placement in the bilateral atrophic maxilla were included. Bio-Oss bovine bone graft was made on one side of the patients and randomly assigned to the control group, and the other side was randomly assigned to the test group using platelet-rich fibrin prepared with titanium.

Conditions

  • Sinus Disease
  • Maxillary Sinus Disease

Interventions

PROCEDURE

maxillary sinus augmentation and implant placement

For maxillary sinus augmentation, the area will be prepared by lifting a full-thickness flap. The sinus membrane will be carefully elevated by opening a window through the lateral wall of the sinus on both sides.platelet-rich fibrin prepared with titanium on the other side will be placed in the space prepared in the sinus region by random selection. For Platelet-rich fibrin prepared with titanium (T-PRF), the blood taken from the patient to a 20 cc injektor was put into titanium tubes and prepared by centrifugation at 2700 rpm for 14 minutes according to the standard protocol. Then, 6 months after the surgery, histological sample will be taken with a trephine bur in both groups and the implant will be placed in accordance with the standard protocol. The stability value (ISQ) of the placed implant will be measured with the Ostell device at the time the implant is placed and 3 months after it is placed.

PROCEDURE

Maxillary sinus augmentation with bovine bone graft

For maxillary sinus augmentation, the area will be prepared by lifting a full-thickness flap. The sinus membrane will be carefully elevated by opening a window through the lateral wall of the sinus on both sides. Bio-oss bovine bone graft on one side will be placed in the space prepared in the sinus region by random selection. For Platelet-rich fibrin prepared, the blood taken from the patient to a 20 cc injektor was put into titanium tubes and prepared by centrifugation at 2700 rpm for 13 minutes according to the standard protocol. Then, 6 months after the surgery, histological sample will be taken with a trephine bur in both groups and the implant will be placed in accordance with the standard protocol. The stability value (ISQ) of the placed implant will be measured with the Ostell device at the time the implant is placed and 3 months after it is placed.

Sponsors & Collaborators

  • Kutahya Health Sciences University

    lead OTHER

Principal Investigators

  • Berceste Güler · Kütahya Health Sciences University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-14
Primary Completion
2023-04-14
Completion
2023-04-14

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05596084 on ClinicalTrials.gov