Bacterial InfectionsNCT05100433
Effect of Passive Ultrasonic Irrigation on Bacteria That Persist After Root Canal Preparation
A study testing Ultrasonic irrigation in people with Bacterial Infections, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study aims to evaluate the effectiveness of ultrasonic irrigation in improving root canal disinfection after chemomechanical procedures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Ultrasonic irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Mar 2018to 25 Nov 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Teeth with necrotic pulps and asymptomatic apical periodontitis
Who cannot join
- patients who had received antibiotics during the previous 3 months or had any general disease,
- teeth that could not be properly isolated with rubber dam,
- non-restored teeth,
- periodontal pockets depths greater than 4 mm,
- previous endodontic treatment,
- open apex,
- crown/root fracture
- root resorption or calcifications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Passive Ultrasonic Irrigation on Bacteria That Persist After Root Canal Preparation in Teeth With Apical Periodontitis
This study aims to evaluate the effectiveness of ultrasonic irrigation in improving root canal disinfection after chemomechanical procedures.
Read the detailed description
Although chemomechanical procedures promote a drastic bacterial reduction, many root canals remain infected, which points to the need for complementary procedures to improve root canal disinfection. Thus, this clinical study aims to evaluate the effect of passive ultrasonic irrigation as a supplementary disinfection procedure after root canal preparation. Microbiological samples of the root canals of 30 single-rooted teeth with apical periodontitis will be taken at different stages of the endodontic treatment: before preparation (S1), after chemomechanical procedures (S2) and after passive ultrasonic irrigation (S3). The samples will be submitted to the quantitative polymerase chain reaction for bacterial quantification and to the reverse transcription quantitative polymerase chain reaction for bacterial activity analysis. Data will be analyzed using the Wilcoxon test for paired samples (p < 0.05).
- Conditions
- Bacterial Infections
- Being tested
- Ultrasonic irrigation
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic irrigationProcedure or surgery
Ultrasonic irrigation will be used as a complementary step to chemomechanical procedures to test whether it can improve root canal disinfection.
| Study group | Role | What they receive |
|---|---|---|
| Microbiological analysis of root canals after endodontic procedures | Experimental | Bacterial levels and activity in root canal samples after chemomechanical procedures and ultrasonic irrigation. Receives: Procedure: Ultrasonic irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial Activity
The metabolic activity of total bacteria in root canal samples after ultrasonic irrigation
Measured: through study completion, an average of 3 years
Secondary outcomes (1)
Bacterial Levels
Quantitative data of total bacteria determined by quantitative polymerase chain reaction after endodontic procedures
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start5 Mar 2018
- Primary completion25 Nov 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ericka Tavares Pinheiro, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100433
- Sponsor's protocol ID
- FAPESP 2016/15473-0-2
- Status last verified
- Nov 2023
- First submitted
- 20 Sep 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Passive Ultrasonic Irrigation on Bacteria That Persist After Root Canal Preparation in Teeth With Apical Periodontitis
- ClinicalTrials.gov ID
- NCT05100433
- Acronym / sponsor ID
- FAPESP 2016/15473-0-2
- Conditions
- Bacterial Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 29 Oct 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.
This study aims to evaluate the effectiveness of ultrasonic irrigation in improving root canal disinfection after chemomechanical procedures.
Detailed description
Although chemomechanical procedures promote a drastic bacterial reduction, many root canals remain infected, which points to the need for complementary procedures to improve root canal disinfection. Thus, this clinical study aims to evaluate the effect of passive ultrasonic irrigation as a supplementary disinfection procedure after root canal preparation. Microbiological samples of the root canals of 30 single-rooted teeth with apical periodontitis will be taken at different stages of the endodontic treatment: before preparation (S1), after chemomechanical procedures (S2) and after passive ultrasonic irrigation (S3). The samples will be submitted to the quantitative polymerase chain reaction for bacterial quantification and to the reverse transcription quantitative polymerase chain reaction for bacterial activity analysis. Data will be analyzed using the Wilcoxon test for paired samples (p < 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microbiological analysis of root canals after endodontic procedures | Experimental | Procedure: Ultrasonic irrigationBacterial levels and activity in root canal samples after chemomechanical procedures and ultrasonic irrigation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Teeth with necrotic pulps and asymptomatic apical periodontitis
Key exclusion criteria (8 listed)
- patients who had received antibiotics during the previous 3 months or had any general disease,
- teeth that could not be properly isolated with rubber dam,
- non-restored teeth,
- periodontal pockets depths greater than 4 mm,
- previous endodontic treatment,
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 |
|---|---|---|
| Ultrasonic irrigationUltrasonic irrigation will be used as a complementary step to chemomechanical procedures to test whether it can improve root canal disinfection. | Procedure or surgery | Microbiological analysis of root canals after endodontic procedures |
Primary outcome
Bacterial Activity
Time frame: through study completion, an average of 3 years
The metabolic activity of total bacteria in root canal samples after ultrasonic irrigation
1 secondary outcome
Bacterial Levels
Time frame: through study completion, an average of 3 years
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 29 Nov 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic irrigation in people with Bacterial Infections, run by University of Sao Paulo 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 1 inclusion and 8 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 29 Nov 2023. 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?
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?
Bacterial Activity (time frame: through study completion, an average of 3 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 29 Nov 2023.