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Completed

NCT Number: NCT03096210

Titanium-Prepared Platelet Rich Fibrin in the Sinus Lifting Procedure

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

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Key information

Conditions

Maxillary Sinus

Age range

42 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Titanium-Prepared Platelet Rich Fibrin

Other

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)

Other

After careful elevation of the schneiderian membrane without perforation, allograft was only used for augmentation of the sinus floor in the control group.

Primary outcomes

  1. Histological Examination

    Time frame: 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 outcomes

  1. Radiological Examination

    Time frame: Within the first 4 and 6 months

    Density (hu) measurements

  2. Implant stability measurements

    Time frame: Within the 3 months after implant surgery

    Implant Stability Quotient values (50-80 ISQ)

Sponsors and collaborators

Lead sponsor

Kırıkkale University

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Mar 30, 2017
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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