Titanium-Prepared Platelet Rich Fibrin in the Sinus Lifting Procedure

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

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

Study Overview

• Status: Completed
• Conditions: Maxillary Sinus
• Intervention / Treatment: Other: Titanium-Prepared Platelet Rich Fibrin; Other: Allograft (CTBA Allograft)

Detailed 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.

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 42 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Titanium-Prepared Platelet Rich Fibrin; After careful elevation of the schneiderian membrane without perforation,T-PRFs were only used in the test group.	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.
OTHER: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological Examination	Density (hu) measurements	Within the first 4 and 6 months
Implant stability measurements	Implant Stability Quotient values (50-80 ISQ)	Within the 3 months after implant surgery

Collaborators and Investigators

• Sponsor: Kırıkkale University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 11, 2013
• Primary Completion (ACTUAL): November 28, 2014
• Study Completion (ACTUAL): March 2, 2015

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (ACTUAL): March 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Allograft; implant; Maxillar sinus; Titanium-Prepared Platelet Rich Fibrin
• Other Study ID Numbers: 2013/05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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