Bacterial Profile Changes During Different Sodium Hypochlorite Irrigation Regimens and Calcium Hy… (NCT07623278) | Clinical Trial Compass
CompletedNot Applicable
Bacterial Profile Changes During Different Sodium Hypochlorite Irrigation Regimens and Calcium Hydroxide Medicament in Root Canal Treatment
Indonesia24 participantsStarted 2025-10-13
Plain-language summary
The goal of this clinical trial is to learn how the bacterial profile in infected root canals changes during different phases of routine root canal treatment in adults with chronic apical abscess. The main questions it aims to answer are:
* How does the root canal bacterial profile change before and after irrigation with 5.25 percent sodium hypochlorite or 3 percent sodium hypochlorite?
* How does the bacterial profile change after calcium hydroxide medicament is placed in the root canal?
Participants will:
* Receive standard root canal treatment with one of two irrigation regimens (5.25 percent or 3 percent sodium hypochlorite, plus EDTA),
* Have root canal samples taken three times (before any treatment, after irrigation, and after calcium hydroxide medicament), and
* Have the bacteria in these samples analyzed using 16S rRNA PCR and DNA sequencing.
Who can participate
Age range
18 Years – 75 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:
* Adult aged between 18 and 75 years.
* Physically and mentally able to undergo treatment
* Have not used antibiotics within 1 week before treatment.
* Permanent molar teeth showing clinical and radiographic signs of chronic apical abscess and considered restorable.
* Willing to participate in the study and able to provide written informed consent after receiving an explanation of the study.
Exclusion Criteria:
* Systemic conditions that require antibiotic prophylaxis for routine dental treatment or other significant systemic disease.
* Pregnant or breastfeeding women.
* Participants with cognitive impairment.
* Teeth with advanced mobility (greater than grade 2).
* Teeth with periodontal pockets deeper than 4 mm.
* Teeth with radiographic signs of root resorption.
* Teeth with calcification or obliteration of the root canal.
* Teeth with root fracture or that fracture during treatment.
* Teeth with open apices.
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
Change in root canal bacterial community profile
Timeframe: Baseline/S1 (before any treatment), immediately after irrigation (S2), and approximately 2 weeks after calcium hydroxide medicament (S3).