Titanium-Prepared Platelet Rich Fibrin in the Sinus Lifting Procedure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-11

Study Completion Date

2015-03-02

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.

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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.

Conditions

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Maxillary Sinus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Titanium-Prepared Platelet Rich Fibrin

After careful elevation of the schneiderian membrane without perforation,T-PRFs were only used in the test group.

Group Type OTHER

Titanium-Prepared Platelet Rich Fibrin

Intervention Type 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)

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

Group Type OTHER

Allograft (CTBA Allograft)

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

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.

Minimum Eligible Age

42 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes