Titanium-Prepared Platelet Rich Fibrin in the Sinus Lifting Procedure

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Maxillary Sinus

Intervention / Treatment
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* Other: Titanium-Prepared Platelet Rich Fibrin
* Other: Allograft (CTBA Allograft)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 42 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Titanium-Prepared Platelet Rich Fibrin<br>After careful elevation of the schneiderian membrane without perforation,T-PRFs were only used in the test group. | Other: Titanium-Prepared Platelet Rich Fibrin<br>* 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.<br>|
| Other: Allograft (CTBA Allograft)<br>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)<br>* After careful elevation of the schneiderian membrane without perforation, allograft was only used for augmentation of the sinus floor in the control group.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maxillar sinus, Titanium-Prepared Platelet Rich Fibrin, Allograft, implant