Ultrasonic debridement of Hyflex EDM files version1
Research type
Research Study
Full title
An Ex Vivo investigation into the effectiveness of ultrasonic activity in the removal of debris accumulations from the flutes of Hyflex EDM endodontic files.
IRAS ID
221517
Contact name
David Blaen
Contact email
Sponsor organisation
University of Chester
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
0 years, 7 months, 1 days
Research summary
This research study aims to find out if direct application of ultrasonic energy is an effective method to remove debris accumulated on the flutes of endodontic files through the mechanical preparation of tooth root canals, when compared with an endodontic sponge. It is hoped that this study will provide information that may be beneficial to dental endodontic treatment outcome.
Successful endodontic treatment is dependent upon the elimination of microorganisms from the root canal structure. Persistence of bacteria in the root anatomy following debridement can increase the risk of treatment failure. Modern endodontic treatment uses rotary or reciprocating files to shape and debride the canal structure together with chemical irrigation to reach areas that mechanical preparation cannot access.
This mechanical debridement activity creates debris, which collects within the root canal, on the canal walls and within the flutes of the nickel titanium files. The contents of the debris may contain dentine particles, remnants of vital or necrotic pulp tissue, bacterial components and retained irrigant. Repeated use of the endodontic file without debridement may lead to the re-introduction of previously eliminated pathogens and affect treatment outcomes.
This study plans to use debris collected from extracted teeth and assess the effectiveness of two methods of file debridement by taking accurate weight measurements before and after cleaning.
The study is self funded by the lead researcher, will take place in a dental practice setting, and should be completed within 3 months of approval. A participant must have consented to and undergone a dental extraction for completely independent and justifiable clinical reasons, and for the benefit of their future dental health. The participant must then consent to the use of their extracted tooth in the study of their own free will without coercion or encouragement. The teeth will be collected from patients of the researcher's practice undergoing routine extractions. The participants will not have any further involvement in the research.
The study will be conducted in the dental practice of the researcher.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
17/YH/0043
Date of REC Opinion
9 Feb 2017
REC opinion
Favourable Opinion