ISRCTN ISRCTN17319710
DOI https://doi.org/10.1186/ISRCTN17319710
Secondary identifying numbers 0001
Submission date
13/04/2018
Registration date
09/05/2018
Last edited
11/09/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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)

Contact information

Dr Gianluca Gambarini
Scientific

University of Rome
Via Caserta 6
Rome
00187
Italy

Study information

Study designPilot single-center observational study
Primary study designObservational
Secondary study designCase series
Study setting(s)Hospital
Study typeNot Specified
Participant information sheet No participant information sheet available
Scientific titleMeasurement of operative torque generated during the preparation of root canals in vivo
Study objectivesThe hypothesis is that different endodontics instruments create different torque values during intracanal instrumentation.
Ethics approval(s)Sapienza University of Rome, 10/04/2017, ref: 528/17
Health condition(s) or problem(s) studiedRoot canal treatments
InterventionThis 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 typeProcedure/Surgery
Primary outcome measureTorque values were measured using a prototype device connected to a regular endodontic motor every 0.1 seconds during the procedure
Secondary outcome measuresThe occurrence of mishaps such as torsional lock or breakage of files were recorded during the procedure
Overall study start date07/10/2016
Completion date15/12/2018

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants10
Total final enrolment10
Key inclusion criteria1. No significant medical history
2. Need root canal treatment in the maxillary premolar tooth
Key exclusion criteria1. Present any medical systemic condition
2. Teeth presenting root fracture, open apex, root resorption or previous root canal treatment.
Date of first enrolment01/01/2018
Date of final enrolment01/03/2018

Locations

Countries of recruitment

  • Italy

Study participating centre

Sapienza Università di Roma - Clinica odontoiatrica
Viale Regina Elena, 287
Rome
00161
Italy

Sponsor information

Sapienza University of Rome
University/education

Via Caserta 6
Rome
001611
Italy

ROR logo "ROR" https://ror.org/02be6w209

Funders

Funder type

University/education

Sapienza Università di Roma
Government organisation / Universities (academic only)
Alternative name(s)
Sapienza University of Rome, Università degli Studi di Roma "La Sapienza”, Sapienza-Università di Roma, Sapienza, Uniroma1
Location
Italy

Results and Publications

Intention to publish date30/06/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planSubmitted for publication in a high-impact peer-reviewed scientific journal in May 2018.
IPD sharing planData 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2019 11/09/2020 Yes No

Editorial Notes

11/09/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
16/07/2018: The plain English summary has been updated.
13/07/2018: The following changes have been made to the trial record:
1. The overall trial end date has been changed from 22/03/2018 to 15/12/2018.
2. The intention to publish date has been changed from 30/11/2018 to 30/06/2019.
3. The scientific title has been changed from "Measurement of operative torque generated during the preparation of root canals in vivo and a comparison of two nickel-titanium rotary instruments" to "Measurement of operative torque generated during the preparation of root canals in vivo".