Nastaran Meschi1,2, Steffen Fieuws3, Anke Vanhoenacker4, Olaf Strijbos5,6, Dominique Van der Veken5,6, Constantinus Politis4, Paul Lambrechts5,6. 1. Department of Oral Health Sciences, Endodontology, KU Leuven & Dentistry, University Hospitals Leuven, Kapucijnenvoer 7 blok a- box 7001, 3000 Leuven, Belgium. nastaran.meschi@kuleuven.be. 2. Biomaterialen-BIOMAT, KU Leuven, Kapucijnenvoer 7 blok a- box 7001, 3000, Leuven, Belgium. nastaran.meschi@kuleuven.be. 3. Leuven Biostatistics and Statistical Bioinformatics Centre, KU Leuven, University of Leuven, Kapucijnenvoer 35 blok d - box 7001, 3000, Leuven, Belgium. 4. Stomatology and Maxillofacial Surgery, KU Leuven & Dentistry, University Hospitals Leuven, Kapucijnenvoer 7 blok a - box 7001, 3000, Leuven, Belgium. 5. Department of Oral Health Sciences, Endodontology, KU Leuven & Dentistry, University Hospitals Leuven, Kapucijnenvoer 7 blok a- box 7001, 3000 Leuven, Belgium. 6. Biomaterialen-BIOMAT, KU Leuven, Kapucijnenvoer 7 blok a- box 7001, 3000, Leuven, Belgium.
Abstract
OBJECTIVES: The aim of this study was to investigate the impact of the adjunct of leukocyte- and platelet-rich fibrin (LPRF) to root-end surgery (RES) on the patients' quality of life during the first week post RES. MATERIALS AND METHODS:Patients in need of RES were recruited for an open randomized controlled clinical trial (RCT) with a 2 × 2 factorial design. They were randomly allocated to the test (+LPRF) and control (-LPRF) group. Each group was subsequently divided into two strata: with or without an occlusive membrane (Bio-Gide®, Geistlich Biomaterials, Switzerland; BG). After RES, the patients completed daily for 1 week a visual analog pain scale (VAS) and a 5-point Likert-type scale questionnaire concerning activity impairment, occurrence of symptoms, and medication use. RESULTS:Fifty patients were included, equally divided between the test and control group. Only one patient in the "-LPRF+BG-group" had to take additional antibiotics due to a persistent jaw swelling. There was no evidence (p ≤ 0.05) for a difference between the test and control group in VAS, occurrence of pain symptoms, impairment of daily activities, and medication use, over the 7 days and daily during the 7 days post RES. CONCLUSIONS: There was no statistical significant evidence for improvement of patients' quality of life during the first week post RES with LPRF in comparison with RES without LPRF. CLINICAL RELEVANCE: Although LPRF seems to be an inexpensive and autologous agent to reduce pain and swelling post RES, this RCT does not provide a statistical significant evidence for that.
RCT Entities:
OBJECTIVES: The aim of this study was to investigate the impact of the adjunct of leukocyte- and platelet-rich fibrin (LPRF) to root-end surgery (RES) on the patients' quality of life during the first week post RES. MATERIALS AND METHODS:Patients in need of RES were recruited for an open randomized controlled clinical trial (RCT) with a 2 × 2 factorial design. They were randomly allocated to the test (+LPRF) and control (-LPRF) group. Each group was subsequently divided into two strata: with or without an occlusive membrane (Bio-Gide®, Geistlich Biomaterials, Switzerland; BG). After RES, the patients completed daily for 1 week a visual analog pain scale (VAS) and a 5-point Likert-type scale questionnaire concerning activity impairment, occurrence of symptoms, and medication use. RESULTS: Fifty patients were included, equally divided between the test and control group. Only one patient in the "-LPRF+BG-group" had to take additional antibiotics due to a persistent jaw swelling. There was no evidence (p ≤ 0.05) for a difference between the test and control group in VAS, occurrence of pain symptoms, impairment of daily activities, and medication use, over the 7 days and daily during the 7 days post RES. CONCLUSIONS: There was no statistical significant evidence for improvement of patients' quality of life during the first week post RES with LPRF in comparison with RES without LPRF. CLINICAL RELEVANCE: Although LPRF seems to be an inexpensive and autologous agent to reduce pain and swelling post RES, this RCT does not provide a statistical significant evidence for that.
Authors: David M Dohan Ehrenfest; Isabel Andia; Matthias A Zumstein; Chang-Qing Zhang; Nelson R Pinto; Tomasz Bielecki Journal: Muscles Ligaments Tendons J Date: 2014-05-08