Plain English Summary
Current plain English summary as of 16/07/2018:
Background and study aims
Root canal treatment (endodontic treatment) is given to patients that have infection or inflammation on the pulp (nerve) inside a tooth, or in the bone surrounding the root area (lower area of the tooth).
Preparing a tooth for root canal treatment using rotary instruments generates torque. Torque generated during root canal preparation depends on the anatomy of the tooth, the type of instruments being used, and how the dentist prepares the canal. Torque can be measured in order to analyse how safe instruments are to use for root canal treatment. This study aims to describe a new method for measuring torque generated during root canal preparation in order to assess safety of different instruments and techniques.
Who can participate?
Adults requiring root canal treatment
What does the study involve?
Participants receive routine root canal treatment under anaesthetic in a single session. The canals are prepared using two types of rotary files and torque values (rotational force) are measured throughout this preparation or both instruments. Participants receive follow up for one year, but this is not part of the study.
What are the possible benefits and risks of participating?
Being an observational study using standard root canal procedures, it does not offer any additional benefits or risks to the participants.
Where is the study run from?
Sapienza University of Rome (Italy)
When is the study starting and how long is it expected to run for?
October 2016 to March 2018
Who is funding the study?
Sapienza University of Rome (Italy)
Who is the main contact?
Dr Gianluca Gambarini (Scientific)
Previous plain English summary:
Background and study aims
Root canal treatment (endodontic treatment) is indicated for patients that present infection or inflammation in the pulp (nerve) inside of a tooth or in the bone surrounding the root area.
This study aims to describe a new method for analyzing operative torque (rotational force) by measuring the torque provided by a motor during the clinical use of nickel-titanium rotary instruments.
Who can participate?
Adults requiring root canal treatment
What does the study involve?
Participants receive routine root canal treatment under anaesthetic in a single session. The canals are prepared using two types of rotary files and torque values (rotational force) are measured throughout this preparation or both instruments. Participants receive follow up for one year, but this is not part of the study.
What are the possible benefits and risks of participating?
Being an observational study using standard root canal procedures, it does not offer any additional benefits or risks to the participants.
Where is the study run from?
Sapienza University of Rome (Italy)
When is the study starting and how long is it expected to run for?
October 2016 to March 2018
Who is funding the study?
Sapienza University of Rome (Italy)
Who is the main contact?
Dr Gianluca Gambarini (Scientific)
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
0001
Study information
Scientific title
Measurement of operative torque generated during the preparation of root canals in vivo
Acronym
Study hypothesis
The hypothesis is that different endodontics instruments create different torque values during intracanal instrumentation.
Ethics approval
Sapienza University of Rome, 10/04/2017, ref: 528/17
Study design
Pilot single-center observational study
Primary study design
Observational
Secondary study design
Case series
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
No participant information sheet available
Condition
Root canal treatments
Intervention
This study aims to describe a new method for analyzing operative torque in vivo by measuring the torque provided by an endodontic motor during the clinical use of nickel-titanium rotary instruments.
Participants are recruited in the dental clinic of the university. All have a prior indication for root canal treatment, and are being evaluated and supervised by the faculty of the institution. Participants are subjected to the regular endodontic treatment under anesthesia and rubber dam in a single session. Access is created with round burs and a manual glide-path is performed up to the apical limit. Then, the canals are prepared using rotary files ProTaper Next X 1 and EdgeEndo X7 (EdgeEndo). The observational study is limited to about 15 minutes during the root canal preparation. Torque values during the progression of the instruments into the canals are recorded every 0.1s. After the preparation, the teeth receive conventional obturation and restoration.
Data regarding torque is analyzed statistically with significance set at P<0.05.
Participants are subjected to the regular 1 year follow up in the clinic, which is not related to the aim and scope of the present study.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Torque values were measured using a prototype device connected to a regular endodontic motor every 0.1 seconds during the procedure
Secondary outcome measures
The occurrence of mishaps such as torsional lock or breakage of files were recorded during the procedure
Overall trial start date
07/10/2016
Overall trial end date
15/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. No significant medical history
2. Need root canal treatment in the maxillary premolar tooth
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
10
Total final enrolment
10
Participant exclusion criteria
1. Present any medical systemic condition
2. Teeth presenting root fracture, open apex, root resorption or previous root canal treatment.
Recruitment start date
01/01/2018
Recruitment end date
01/03/2018
Locations
Countries of recruitment
Italy
Trial participating centre
Sapienza Università di Roma - Clinica odontoiatrica
Viale Regina Elena, 287
Rome
00161
Italy
Funders
Funder type
University/education
Funder name
Sapienza Università di Roma
Alternative name(s)
Sapienza University of Rome
Funding Body Type
unknown
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Submitted for publication in a high-impact peer-reviewed scientific journal in May 2018.
IPD sharing statement:
Data of the present study is stored in the DIPARTIMENTO DI SCIENZE ODONTOSTOMATOLOGICHE E MAXILLO FACCIALI of the La Sapienza University. Access to the data should be requested to the principal investigator Dr. Gianluca Gambarini.
Participants of this study signed a consent form. Their personal information was stored only on the dental clinic's charts, under the privacy policy of the university. Their information was linked only to the chart number and a new code was addressed for each participant to ensure that stored data is non-identified.
Intention to publish date
30/06/2019
Participant level data
Stored in repository
Basic results (scientific)
Publication list
2019 results in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6938430/ (added 11/09/2020)