An interventional study of Ultrasonic irrigation in Bacterial Infections, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-11-29.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
This study aims to evaluate the effectiveness of ultrasonic irrigation in improving root canal disinfection after chemomechanical procedures.
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).
665 studies on the registry are indexed under Bacterial Infections; 99 are open to participants now.
This study's enrollment of 30 is below the median of 80 across 410 interventional studies indexed under Bacterial Infections.
Browse Bacterial Infections studies →University of Sao Paulo is the lead sponsor of 1,030 studies on the registry; 92 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Bacterial levels and activity in root canal samples after chemomechanical procedures and ultrasonic irrigation.
Procedure: Ultrasonic irrigation
Ultrasonic irrigation will be used as a complementary step to chemomechanical procedures to test whether it can improve root canal disinfection.
Bacterial Activity
The metabolic activity of total bacteria in root canal samples after ultrasonic irrigation
Time frame: through study completion, an average of 3 years
Bacterial Levels
Quantitative data of total bacteria determined by quantitative polymerase chain reaction after endodontic procedures
Time frame: through study completion, an average of 3 years
Ran from Mar 2018 to primary completion in Nov 2022, 56 months.
Of 65 non-industry interventional studies with no phase under Bacterial Infections, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 48. This study's 56 months is above that.
Counting every sponsor, half of 69 studies reached it within 24 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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