The Effect of Using Octenidine Hydrochloride as a Final Irrigation Solution on Teeth With Asympto… (NCT07173725) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Using Octenidine Hydrochloride as a Final Irrigation Solution on Teeth With Asymptomatic Apical Periodontitis on Postoperative Pain and Treatment Success: A Prospective Randomized Clinical Study
This single-centre, randomized, parallel-group clinical trial compared two commonly used final irrigants in single-visit root canal treatment: octenidine dihydrochloride (OCT) and chlorhexidine (CHX). Adults with single-rooted, single-canal teeth diagnosed with asymptomatic apical periodontitis were treated in one visit under local anaesthesia and rubber-dam isolation. After shaping with sodium hypochlorite and smear-layer removal with EDTA, the assigned final irrigant was delivered and sonically activated. In both groups, OCT 0.1 percent or CHX 2 percent was activated using three 20-second cycles, and the solution was refreshed with 2 mL between cycles (approximate total 6 mL). Postoperative pain was recorded by participants on an 11-point Numeric Rating Scale (0 = no pain, 10 = worst pain) at 6, 12, 24, and 48 hours. The primary outcome was pain at 48 hours. Secondary outcomes were pain at earlier time points, use of rescue analgesics within 0-48 hours, and unplanned urgent care within 48 hours. The aim was to determine whether OCT reduces early postoperative pain compared with CHX when used as the final irrigant in single-visit endodontics.
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:
* Adults aged 18 to 65 years (inclusive)
* Single-rooted, single-canal tooth
* Diagnosis of asymptomatic apical periodontitis on periapical radiographs
* Able and willing to provide written informed consent
* Able to complete a 48-hour pain diary (6 h, 12 h, 24 h, 48 h)
Exclusion Criteria:
* Symptomatic apical periodontitis or acute apical abscess
* Previous root canal treatment of the study tooth
* Systemic condition requiring antibiotic prophylaxis or that interferes with pain assessment
* Pregnancy or lactation
* Known allergy or contraindication to study irrigants/materials
* Use of analgesics or anti-inflammatory drugs within 12 hours before treatment
* Inability to comply with study procedures
* More than one eligible tooth (one patient = one tooth rule; a pre-specified index tooth is selected)
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.