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Endodontically Treated TeethNCT05128266

Broken Instrument Removal

An observational study of Endodontically Treated Teeth and Endodontical Retreatment, run by Catholic University of the Sacred Heart.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aims of this retrospective analysis are (1) to evaluate the success rate of a non-surgical retreatment of teeth with broken file instrument into the canal using ultrasounds, microscope and a modified spinal needle, (2) to assess the outcome of the treatment if the remaining fragment was left, bypassed or removed… Read more about this study

Who is it for?
Any age
What is being tested?
Endodontical Retreatment
Type of treatment
Surgery or procedure
How many people
161 participants
Where
No sites listed yet
Study dates
1 Jan 1991to 31 Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients needing an endodontic retreatment due to a separated instrument inside a root canal.

Who may be able to join

  • All patients who received an endodontic retreatment due to a separated instrument inside a root canal were included in this study.

Who cannot join

  • Exclusion criteria were unavailability of complete clinical data or the use of other retreatment techniques.

About this study

Official title: Broken Endodontic Instrument Removal Using Ultrasounds, Microscope and a Modified Spinal Needle

The aims of this retrospective analysis are (1) to evaluate the success rate of a non-surgical retreatment of teeth with broken file instrument into the canal using ultrasounds, microscope and a modified spinal needle, (2) to assess the outcome of the treatment if the remaining fragment was left, bypassed or removed from the root canal in terms of survival rate of the treated teeth after a 5-years follow up period.

Read the detailed description

The fracture of an endodontic instrument is a frustrating phenomenon, both for practitioners and patients, that can compromise the cleaning and shaping procedures of the root canal treatment, with a potential impact on the treatment outcome. In the past decades, the advent of rotary nickel titanium instruments resulted in an increased incidence of instrument separation.

Two mechanisms have been reported in order to describe the fracture of an endodontic instrument inside the root canal: torsional stress and cyclic fatigue. Cyclic failure is due to the constant tension and compression which insists on the file when it shapes the maximal root canal curvature area. Torsional failure occurs when the tip of the instrument locks on the wall of the root canal while the shafts keeps rotating, and the torque exceeds the plastic limit of the metal.

Several studies focused on causes and factors influencing the weakening of endodontic instrument after clinical use, and some recommendation were given trying to minimized the risk of instruments breakage. Nevertheless, this problem can still occur, even to an experienced operator, making the achievement of a correct and predictable root canal final treatment uncertain.

Due to their complexity, many of these cases are approached by extraction and implant replacement of the so evaluated "hopeless" tooth. Treatment decisions can vary widely among dentists and dental specialists and may be based more on personal values and experience than an objective analysis of treatment benefits, risks, costs, prognosis, and alternatives.

At present, there is no standardized procedure for safe and consistently successful instrument fragment removal in the dental literature.

Different devices, techniques, methods, and protocols used for removal of separated instruments are described in literature. Unfortunately, there is a lack of high-level evidence, since most of the papers refer to clinical case report.

Until the beginning of endodontics, dentists have had to face this problem and already in the last century Masserann invented an instrument to remove obstacles in the root canals. Some authors believe that Masserann instrument used by expert hands does not expose the tooth to the root fracture, but this risk remains very high. Several other instruments were invented as a result, many of them similar to the Masserann extractor, others using micro tweezers or cyanoacrylate glue.

To solve the problem of root canal obstruction due to fragments of root canal instruments, some authors make use of the technique of intentional reimplantation after retreatment of the tooth out of the mouth. Recently, some authors have also used the Nd: YAG laser to remove broken instruments in the canals. Laser energy has been used to melt the solder, connecting the separated instrument with the brass tube.

Furthermore, the literature is not clear about the actual need to remove the instruments from the root canals, neither about the percentage of successes in case of bypassing the fragment or about the persistence of the instrument in the root canal.

Independently from the technique, the optimal management of instrument fragments during root canal treatment is crucial in order to enable sufficient debridement and obturation of the root canal system. However, all clinicians agree that the best help in this procedure came by the combined use of ultrasound and the operative microscope. These two devices used in combination allow a more efficient and accurate work, lowering the risk of weakening the canal wall or create root perforations.

The aims of this retrospective analysis are (1) to evaluate the success rate of a non-surgical retreatment of teeth with broken file instrument into the canal using ultrasounds, microscope and a modified spinal needle, (2) to assess the outcome of the treatment if the remaining fragment was left, bypassed or removed from the root canal in terms of survival rate of the treated teeth after a 5-years follow up period.

Being tested
Endodontical Retreatment
Medical subject headings
Tooth, Nonvital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endodontical RetreatmentProcedure or surgery

    1. Linear canal Removal of the coronal dentine in order to create the space useful to an extractor to catch and remove the instrument. The preferred instrument to reach this aim is a .15 or .20 ultrasonic tip.
    2. Curve canal When the instrument is broken inside a curve canal, it is not possible to create a circumferential space around the separated instrument without the risk of root perforation. Thus, the first step is the removal of the dentine of the external wall of the root canal. The second step is the removal of the dentine of the internal wall of the root canal. This selective removal of dentinal tissue unlocks thee separated instrument and determines its mobilization. Thus, the irrigation itself makes the instrument available for the removal.

    After the removal of the broken instrument, root canal preparation was completed Canal filling was performed based on Schilder's technique.

Study groups in NCT05128266
Study groupRoleWhat they receive
Endodontical Retreatmentnon-surgical retreatment of teeth with broken file instrument into the canal using ultrasounds, microscope and a modified spinal needle
Receives: Procedure: Endodontical Retreatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Success rate of a non-surgical retreatment

    Number of non extracted teeth

    Measured: after 5-years follow-up

Secondary outcomes (6)
  1. Influence of the type of Tooth on the outcome of the treatment

    Molar, Premolar, Canine, Incisor

    Measured: After 5-years follow-up

  2. Influence of the type of Root Canal on the outcome of the treatment

    Curve or Linear Canal

    Measured: After 5-years follow-up

  3. Influence of the corono-apical level of the fracture on the outcome of the treatment

    Coronal, Medium, Apical third of the root canal

    Measured: After 5-years follow-up

  4. Influence of the presence of periapical lesion on the outcome of the treatment

    Yes or Not

    Measured: After 5-years follow-up

  5. Influence of the presence of a root fracture on the outcome of the treatment

    Yes or Not

    Measured: After 5-years follow-up

  6. Influence of the presence of a root perforation on the outcome of the treatment

    Yes or Not

    Measured: After 5-years follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2021
  2. Study start1 Jan 1991
  3. Primary completion31 Dec 2014
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05128266
Sponsor's protocol ID
Oss-R-233
Status last verified
May 2023
First submitted
9 Nov 2021
Last updated
9 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Malentacca A, Zaccheo F, Rupe C, Lajolo C. Endodontic Clinical Outcome after Separated Instrument Removal Using a Spinal Needle Technique: A Retrospective Study of Thirty Years of Clinical Experience. J Endod. 2023 Aug;49(8):980-989. doi: 10.1016/j.joen.2023.06.007. Epub 2023 Jul 7.

    PubMed 37422250

Questions about this trial

What is this clinical trial studying?

An observational study of Endodontically Treated Teeth and Endodontical Retreatment, run by Catholic University of the Sacred Heart.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate of a non-surgical retreatment (time frame: after 5-years follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05128266, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.

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