Titanium-Prepared Platelet Rich Fibrin in the Sinus Lifting Procedure

Not Applicable

Completed

• Conditions: Maxillary Sinus
• Interventions: Other: Titanium-Prepared Platelet Rich Fibrin; Other: Allograft (CTBA Allograft)

• Registration Number: NCT03096210
• Lead Sponsor: Kırıkkale University

Brief 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.

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 Timeline

• Study Start: 2013-03-11
• Primary Completion: 2014-11-28
• Study Completion: 2015-03-02
• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Titanium-Prepared Platelet Rich Fibrin	Titanium-Prepared Platelet Rich Fibrin	After careful elevation of the schneiderian membrane without perforation,T-PRFs were only used in the test group.
Allograft (CTBA Allograft)	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.

Primary Outcome Measures

Name	Time	Method
Histological Examination	At the first 4 and 6th months post surgery for the test and control groups, respectively.	Percentage (%) of new and old trabeculae formation post surgery

Secondary Outcome Measures

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