Condition category
Oral Health
Date applied
13/04/2018
Date assigned
09/05/2018
Last edited
16/07/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Gianluca Gambarini

ORCID ID

Contact details

University of Rome
Via Caserta 6
Rome
00187
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0001

Study information

Scientific title

Current scientific title as of 13/07/2018:
Measurement of operative torque generated during the preparation of root canals in vivo

Previous scientific title:
Measurement of operative torque generated during the preparation of root canals in vivo and a comparison of two nickel-titanium rotary instruments

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

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

Sponsor information

Organisation

Sapienza University of Rome

Sponsor details

Via Caserta 6
Rome
001611
Italy

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Sapienza Università di Roma

Alternative name(s)

Sapienza University of Rome

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Italy

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

Publication citations

Additional files

Editorial Notes

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 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 updated