Autologous Platelet Concentrate (APC) in Intrabony Defects

NARecruitingINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

March 2, 2021

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Periodontal Diseases
Interventions
PROCEDURE

Simplified Papilla Preservation Flap (SPPF) and PRGF ENDORET (PRGF ENDORET®-KMU16)

"A simplified papilla preservation flap (SPPF) will be performed. The clot phase of PRGF ENDORET (F2) will be placed in the defect, while the fibrin membrane phase (F1) will cover it.~Blood will be extracted and collected in dedicated tubes and then centrifuged. Up to 8 tubes of 9ml will be extracted. The time from the start of the extraction to the start of the centrifugation of the tubes must not exceed 4mins.~After centrifugation, the blood is separated into three components: Plasma rich in growth factors, White cells or leukocytes, red blood cells: this is the red column occupying the bottom of the tube.~Following BTI's instructions, fractioning of the centrifuged blood will be performed in order to separate Fraction 2 (F2), which contains a greater number of platelets and growth factors and will be used as a clot inside the periodontal defect from Fraction 1 (F1), which will be used as a fibrin member to cover the clot. The flaps will be repositioned and sutured."

PROCEDURE

Simplified Papilla Preservation Flap (SPPF) and GTR

A simplified papilla preservation flap (SPPF) will be performed. The defect will then be treated according to the guided tissue regeneration (GTR) principle (control group). A deproteinized bovine bone mineral (DBBM) graft will be placed in the defect and covered by a collagen membrane.

Trial Locations (1)

E1 2AD

RECRUITING

Barts and The London Dental Hospital, London

All Listed Sponsors
lead

Queen Mary University of London

OTHER