Endodontically Treated TeethNCT03490526
Root Canal Disinfection: a Comparison Between Techniques
A study testing Root canal disinfection with XP-endo Finisher and Root canal disinfection with passive ultrasonic irrigation in people with Endodontically Treated Teeth, run by Federal University of Pelotas at 1 site in Brazil.
Trial summary
Caries disease is still the leading cause of severe tooth decay. Since this can lead to tooth loss, it is important that appropriate treatment is advised to help prevent damage and maintain tooth health. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontically Treated Teeth
- What is being tested?
- Root canal disinfection with XP-endo Finisher and Root canal disinfection with passive ultrasonic irrigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- 2 May 2018to 30 Apr 2020
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old or more;
- good general healthy;
- molars or premolar requiring endodontic treatment;
- at least 20 teeth;
Who cannot join
- root fracture;
- injury involving the furcation region
- need to behave as a prosthetic abutment;
- mobility greater than degree I;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Pelotas
Pelotas, Rio Grande do Sul, 96015560
Tatiana Pereira Cenci, PhD, 53 981114509, tatiana.dds@gmail.com
Fernanda Geraldo Pappen, PhD, 53 32256741, ferpappen@gmail.com
About this study
Official title: Comparison Between Two Different Techniques of Root Canal Disinfection (XP-endo Finisher Versus Passive Ultrasonic Irrigation): Randomized Clinical Trial
Caries disease is still the leading cause of severe tooth decay. Since this can lead to tooth loss, it is important that appropriate treatment is advised to help prevent damage and maintain tooth health. Faced with major coronary destruction, several times it becomes necessary to perform the endodontic treatment, aiming to maintain the element in the buccal cavity for longer. It is known that an excellent restorative treatment with poor endodontic treatment and vice versa has a direct impact on the (in) success of the treatment. In this context, the proper cleaning of the root canals is highlighted, aiming the removal of bacteria and toxins. There are several cleaning methods described in the literature, but it is not yet known which would be the most effective in the removal of these contaminants. In this double-blind randomized clinical trial, patients who need and meet the inclusion criteria will undergo endodontic treatment in two different root canal cleansing techniques (passive ultrasonic cleaning and cleaning with the XP Endo device). Patients will be monitored annually after finish your endodontic treatment to evaluate the periradicular repair and the quality of endodontic treatment.
- Conditions
- Endodontically Treated Teeth
- Being tested
- Root canal disinfection with XP-endo Finisher, Root canal disinfection with passive ultrasonic irrigation
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal disinfection with XP-endo FinisherDevice
The XP-Endo® finisher will be used next to the X-Smart Plus endodontic motor, with speed settings at 800rpm and torque at 1 N.cm. Irrigation with 17% EDTA and 2.5% NaOCl will be performed in three cycles of one minute each. In each cycle the XP-Endo will be used in the working length in continuous and slow movements of entrance and exit, with amplitude of 5mm, for a period of 1 minute, followed by new irrigation with 2.5ml of EDTA solution or hypochlorite of sodium 2,5%. Finally, the channel will be completely dry with absorbent paper tips
Root canal disinfection with passive ultrasonic irrigationDevice
For cleaning using passive ultrasonic irrigation, the E1 Irrisonic tip (Helse Ultrasonic, Ribeirão Preto, SP), will be used with Jetlaxis Sonic BP LED (Schuster, Santa Maria, RS). The insert has a diameter equivalent to a manual file 20, with reduced taper (0.01). The power used will be 10%. With root canals flooded with 17% EDTA, the irrigation tips will be coupled to the ultrasound and 1mm shorter than the working length. These tips will be kept in the center of the canal avoiding contact with the dentin walls. The irrigation will be performed in three cycles, and in each cycle the irrigation tips will be activated for 1 minute followed by new irrigation with 2.5ml EDTA. The same procedure will be repeated with 2.5% NaoCl. Finally, the channel will be completely dry with absorbent paper tips.
| Study group | Role | What they receive |
|---|---|---|
| Root canal disinfection with XP-endo Finisher | Experimental | Not described Receives: Device: Root canal disinfection with XP-endo Finisher |
| Root canal disinfection with passive ultrasonic irrigation | Active comparator | Not described Receives: Device: Root canal disinfection with passive ultrasonic irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periradicular repair
This outcome will be evaluated radiographically by one calibrated examiner.
Measured: 2 years
Secondary outcomes (1)
Quality of endodontic treatment
This outcome will be evaluated through a radiograph by one calibrated examiner.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start2 May 2018 (estimated)
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximiliano Sergio Cenci, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490526
- Sponsor's protocol ID
- PPGO0024
- Status last verified
- Apr 2018
- First submitted
- 15 Mar 2018
- Last updated
- 6 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Different Techniques of Root Canal Disinfection (XP-endo Finisher Versus Passive Ultrasonic Irrigation): Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03490526
- Acronym / sponsor ID
- PPGO0024
- Conditions
- Endodontically Treated Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- 2 May 2018 (estimated)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 6 Apr 2018 (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.
Caries disease is still the leading cause of severe tooth decay. Since this can lead to tooth loss, it is important that appropriate treatment is advised to help prevent damage and maintain tooth health. Faced with major coronary destruction, several times it becomes necessary to perform the endodontic treatment, aiming to maintain the element in the buccal cavity for longer. It is known that an excellent restorative treatment with poor endodontic treatment and vice versa has a direct impact on the (in) success of the treatment. In this context, the proper cleaning of the root canals is highlighted, aiming the removal of bacteria and toxins. There are several cleaning methods described in the literature, but it is not yet known which would be the most effective in the removal of these contaminants. In this double-blind randomized clinical trial, patients who need and meet the inclusion criteria will undergo endodontic treatment in two different root canal cleansing techniques (passive ultrasonic cleaning and cleaning with the XP Endo device). Patients will be monitored annually after finish your endodontic treatment to evaluate the periradicular repair and the quality of endodontic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Root canal disinfection with XP-endo Finisher | Experimental | Device: Root canal disinfection with XP-endo Finisher |
| Root canal disinfection with passive ultrasonic irrigation | Active comparator | Device: Root canal disinfection with passive ultrasonic irrigation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or more;
- good general healthy;
- molars or premolar requiring endodontic treatment;
- at least 20 teeth;
Key exclusion criteria (4 listed)
- root fracture;
- injury involving the furcation region
- need to behave as a prosthetic abutment;
- mobility greater than degree I;
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 |
|---|---|---|
| Root canal disinfection with XP-endo FinisherThe XP-Endo® finisher will be used next to the X-Smart Plus endodontic motor, with speed settings at 800rpm and torque at 1 N.cm. Irrigation with 17% EDTA and 2.5% NaOCl will be performed in three cycles of one minute each. In each cycle the XP-Endo will be used in the working length in continuous and slow movements of entrance and exit, with amplitude of 5mm, for a period of 1 minute, followed by new irrigation with 2.5ml of EDTA solution or hypochlorite of sodium 2,5%. Finally, the channel will be completely dry with absorbent paper tips | Device | Root canal disinfection with XP-endo Finisher |
| Root canal disinfection with passive ultrasonic irrigationFor cleaning using passive ultrasonic irrigation, the E1 Irrisonic tip (Helse Ultrasonic, Ribeirão Preto, SP), will be used with Jetlaxis Sonic BP LED (Schuster, Santa Maria, RS). The insert has a diameter equivalent to a manual file 20, with reduced taper (0.01). The power used will be 10%. With root canals flooded with 17% EDTA, the irrigation tips will be coupled to the ultrasound and 1mm shorter than the working length. These tips will be kept in the center of the canal avoiding contact with the dentin walls. The irrigation will be performed in three cycles, and in each cycle the irrigation tips will be activated for 1 minute followed by new irrigation with 2.5ml EDTA. The same procedure will be repeated with 2.5% NaoCl. Finally, the channel will be completely dry with absorbent paper tips. | Device | Root canal disinfection with passive ultrasonic irrigation |
Primary outcome
Periradicular repair
Time frame: 2 years
This outcome will be evaluated radiographically by one calibrated examiner.
1 secondary outcome
Quality of endodontic treatment
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Root canal disinfection with XP-endo Finisher and Root canal disinfection with passive ultrasonic irrigation in people with Endodontically Treated Teeth, run by Federal University of Pelotas at 1 site in Brazil.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periradicular repair (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2018; AzTrials last refreshed its copy on 28 Oct 2026.