Clinical Investigation of Chemomechanical Parameters for an Efficient Disinfection of the Root Canal (NCT06949176) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Investigation of Chemomechanical Parameters for an Efficient Disinfection of the Root Canal
Greece44 participantsStarted 2023-12-01
Plain-language summary
The aim of the study is first, to evaluate the clinical antibacterial efficacy of two different NaOCl concentrations (2,5% and 5%) under a predefined irrigant flow rate in teeth with pulp necrosis and apical periodontitis by using Real-time PCR. . Second, to evaluate the efficacy of final irrigation by assessing, if possible, a numerical definition for that "so called" as "copious irrigation".
Besides the total microbial load, the antibacterial efficacy of final irrigation procedure against two different bacterial species (namely Pseudoramibacter alactolyticus and Treponema denticola) will also be examined.
Who can participate
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:
* Informed consent by the patients who wish to participate in the study.
* Single-rooted teeth with pulp necrosis confirmed by pulp sensibility tests, negative response to both cold and electric pulp testing and radiographic evidence of apical periodontitis.
* Teeth with relatively straight canals, complete root development and no pulp canal obliteration.
Exclusion Criteria:
* Patients who have received antibiotic treatment the last 3 months or need chemoprophylaxis for dental treatment.
* Teeth with previous endodontic treatment.
* Teeth with cracks or incomplete vertical root fracture which disturbs the integrity of the pulp chamber walls.
* Teeth with periodontal pocket more than 4mm.
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
Reduction of total bacterial load after chemomechanical preparation using 2.5% and 5% NaOCl.
Timeframe: DAY 1: Immediately after chemomechanical preparation.
2
Reduction of total bacterial load after chemomechanical preparation using 2.5% and 5% NaOCl.
Timeframe: DAY 1: Immediately after final irrigation.
3
Clinical and radiographic treatment success.
Timeframe: 1 year post tratment.
Trial details
NCT IDNCT06949176
SponsorNational and Kapodistrian University of Athens