Torque in root canal preparations
| 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
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
Scientific
University of Rome
Via Caserta 6
Rome
00187
Italy
Study information
| Study design | Pilot single-center observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Participant information sheet | No participant information sheet available |
| Scientific title | Measurement of operative torque generated during the preparation of root canals in vivo |
| Study objectives | The 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) studied | 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 |
| 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 study start date | 07/10/2016 |
| Completion date | 15/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 10 |
| Total final enrolment | 10 |
| Key inclusion criteria | 1. No significant medical history 2. Need root canal treatment in the maxillary premolar tooth |
| Key exclusion criteria | 1. Present any medical systemic condition 2. Teeth presenting root fracture, open apex, root resorption or previous root canal treatment. |
| Date of first enrolment | 01/01/2018 |
| Date of final enrolment | 01/03/2018 |
Locations
Countries of recruitment
- Italy
Study participating centre
Rome
00161
Italy
Sponsor information
University/education
Via Caserta 6
Rome
001611
Italy
"ROR" |
https://ror.org/02be6w209 |
|---|
Funders
Funder type
University/education
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 date | 30/06/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Submitted for publication in a high-impact peer-reviewed scientific journal in May 2018. |
| IPD sharing plan | 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. |
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".
