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
1 other identifier
interventional
18
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2013
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2015
CompletedFirst Submitted
Initial submission to the registry
March 8, 2017
CompletedFirst Posted
Study publicly available on registry
March 30, 2017
CompletedSeptember 4, 2020
September 1, 2020
1.7 years
March 8, 2017
September 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Radiological Examination
Within the first 4 and 6 months
Implant stability measurements
Within the 3 months after implant surgery
Study Arms (2)
Titanium-Prepared Platelet Rich Fibrin
OTHERAfter careful elevation of the schneiderian membrane without perforation,T-PRFs were only used in the test group.
Allograft (CTBA Allograft)
OTHERAfter careful elevation of the schneiderian membrane without perforation, allograft was only used for augmentation of the sinus floor in the control group.
Interventions
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.
After careful elevation of the schneiderian membrane without perforation, allograft was only used for augmentation of the sinus floor in the control group.
Eligibility Criteria
You may qualify if:
- Participants having been diagnosed to display a residual crest height of less than 5mm in posterior maxilla and non-smokers were included.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.Dr.
Study Record Dates
First Submitted
March 8, 2017
First Posted
March 30, 2017
Study Start
March 11, 2013
Primary Completion
November 28, 2014
Study Completion
March 2, 2015
Last Updated
September 4, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share