Quantitative Assessment of the Efficacy of Two Irrigation Activation Systems (NCT05690763) | Clinical Trial Compass
CompletedNot Applicable
Quantitative Assessment of the Efficacy of Two Irrigation Activation Systems
Turkey (Türkiye)20 participantsStarted 2022-02-07
Plain-language summary
Aim of the present study was to determine the intraradicular microbiota of previously root canal-treated teeth with apical periodontitis using droplet digital polymerase chain reaction (ddPCR) and to investigate the antibacterial effectiveness of different irrigation activation methods \[ XP-endo Finisher and EndoActivator \] that will make classical chemomechanical preparation more effective. This superiority, parallel, randomized clinical trial was conducted in the clinic of the Endodontic Department, Faculty of Dentistry, Istanbul Medipol University, Istanbul. 20 patients with posttreatment apical periodontitis (one tooth each) were randomly allocated into two groups according to the used (n=10, for each): the EA group (A) or the XPF group (B). Total bacterial loads, as well as the amount of Enterococcus faecalis (E.faecalis) were determined before (S1) and after (S2) chemomechanical preparation and finally, after intracanal medication (S3) by means of ddPCR.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* root canal-treated teeth exhibiting clinical and radiographic evidence of chronic apical periodontitis lesions.
* Teeth with post-treatment apical periodontitis had endodontic therapy completed more than 2 years earlier and required retreatment.
* Radiographically, the diameter of the periapical radiolucency ranged from 2 to 7 mm.
* Termini of the root canal fillings ranged from 0-4 mm short of the radiographic apex, with no overfilling.
* The teeth had intact coronal restorations, with no obvious exposure of the root-filling material to the oral cavity.
* Selected teeth had enough crown structure for adequate isolation with a rubber dam and showed an absence of periodontal pockets or attachment level deeper than 4 mm.
Exclusion Criteria:
* teeth from patients who had received antibiotics within the previous 3 months or who had any general disease, teeth that could not be properly isolated with rubber dam, teeth with absence of coronary sealing, teeth with periodontal pocket depth \>4 mm; and teeth with crown/root fracture. Only one tooth was included from each patient.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the sequence analysis of 16S rRNA genes by the Sanger sequencing
Timeframe: through study completion, an average of 1 year