Titanium-Prepared Platelet Rich Fibrin in the Sinus Lifting Procedure

Maxillary Sinus Clinical Trial

Official title:

Comparison of the Clinic, Radiographic and Histological Effects of Allograft and T-PRF (Titanium-Prepared Platelet Rich Fibrin) Materials in the Sinus Lifting Procedure. Preliminary Results From a Pilot Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03096210
• Other study ID #: 2013/05
• Status: Completed
• Phase: N/A
• Start date: March 11, 2013
• Est. completion date: March 2, 2015

Study information

• Verified date: September 2020
• Source: Kirikkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the radiographic, histological and clinical comparisons of the completely autologous T-PRF or allograft effectiveness at the maxillary sinus elevation procedure.

Description:

Participants randomly divided into 2 groups and the test group had a Schneiderian membrane elevation with using balloon lifting technique and after that sinus was filled with T-PRF produced from the patients' blood and 4 months waiting period has been entered. At the end of the 4th month, the bone samples were received from the implant slots and sent to histological evaluation. After 3 months, implant stability was measured and recorded. In the control group, the same procedures were followed and sinus was filled with only allograft. Waiting period was changed to 6 months for this group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2, 2015
• Est. primary completion date: November 28, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Years to 69 Years

Eligibility

Inclusion Criteria:

• Participants having been diagnosed to display a residual crest height of less than 5mm in posterior maxilla and non-smokers were included.

Exclusion Criteria:

• Participants with blood platelet disorders, infectious and metabolic diseases, ongoing chemotherapy or radiotherapy, history of chronic sinusitis associated with maxillary sinuses, taking any antibiotics and/or anti-inflammatory drugs were excluded.

Related Conditions & MeSH terms

• Maxillary Sinus

Intervention

Other:
• Titanium-Prepared Platelet Rich Fibrin
Blood samples were collected from the each participant's arm in the test group by 20 ml syringe and then was transferred into 10ml grade IV titanium tube without anticoagulant. After centrifugation of blood samples (2800 rpm, 12 minutes) at room temperature, the T-PRF clot was removed from the tubes with sterile tweezers. 6 blood tubes were collected for a sinus floor elevation/lifting operation and 6 T-PRFs were prepared for each participant.
• Allograft (CTBA Allograft)
After careful elevation of the schneiderian membrane without perforation, allograft was only used for augmentation of the sinus floor in the control group.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kirikkale University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological Examination	Percentage (%) of new and old trabeculae formation post surgery	At the first 4 and 6th months post surgery for the test and control groups, respectively.
Secondary	Radiological Examination	Density (hu) measurements	Within the first 4 and 6 months
Secondary	Implant stability measurements	Implant Stability Quotient values (50-80 ISQ)	Within the 3 months after implant surgery