Endodontically Treated TeethNCT05128266
Broken Instrument Removal
An observational study of Endodontically Treated Teeth and Endodontical Retreatment, run by Catholic University of the Sacred Heart.
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
- Conditions the study is for
- Endodontically Treated Teeth, Endodontical Retreatment
- 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
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| Endodontical Retreatment | non-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.
Success rate of a non-surgical retreatment
Number of non extracted teeth
Measured: after 5-years follow-up
Secondary outcomes (6)
Influence of the type of Tooth on the outcome of the treatment
Molar, Premolar, Canine, Incisor
Measured: After 5-years follow-up
Influence of the type of Root Canal on the outcome of the treatment
Curve or Linear Canal
Measured: After 5-years follow-up
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
Influence of the presence of periapical lesion on the outcome of the treatment
Yes or Not
Measured: After 5-years follow-up
Influence of the presence of a root fracture on the outcome of the treatment
Yes or Not
Measured: After 5-years follow-up
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.
- First posted19 Nov 2021
- Study start1 Jan 1991
- Primary completion31 Dec 2014
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endodontically Treated TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Lajolo, Catholic University of the Sacred Heart
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
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Broken Endodontic Instrument Removal Using Ultrasounds, Microscope and a Modified Spinal Needle
- ClinicalTrials.gov ID
- NCT05128266
- Acronym / sponsor ID
- Oss-R-233
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 1 Jan 1991 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endodontical Retreatment | – | Procedure: Endodontical Retreatmentnon-surgical retreatment of teeth with broken file instrument into the canal using ultrasounds, microscope and a modified spinal needle |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients needing an endodontic retreatment due to a separated instrument inside a root canal.
Key inclusion criteria (1 listed)
- All patients who received an endodontic retreatment due to a separated instrument inside a root canal were included in this study.
Key exclusion criteria (1 listed)
- Exclusion criteria were unavailability of complete clinical data or the use of other retreatment techniques.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endodontical Retreatment1. 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. | Procedure or surgery | Endodontical Retreatment |
Primary outcome
Success rate of a non-surgical retreatment
Time frame: after 5-years follow-up
Number of non extracted teeth
6 secondary outcomes
Influence of the type of Tooth on the outcome of the treatment
Time frame: After 5-years follow-up
Influence of the type of Root Canal on the outcome of the treatment
Time frame: After 5-years follow-up
Influence of the corono-apical level of the fracture on the outcome of the treatment
Time frame: After 5-years follow-up
Influence of the presence of periapical lesion on the outcome of the treatment
Time frame: After 5-years follow-up
Influence of the presence of a root fracture on the outcome of the treatment
Time frame: After 5-years follow-up
Influence of the presence of a root perforation on the outcome of the treatment
Time frame: After 5-years follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Derived from this study: PubMed 37422250Malentacca 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.