An interventional study of Octenidine dihydrochloride 0.1% and Chlorhexidine 2% in Apical Periodontitis and Postoperative Pain, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Treatment
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.
Design and setting. Prospective, randomized, parallel-group, blinded clinical trial conducted at a university dental hospital (Istanbul, Turkey). All treatments were completed in a single visit by an experienced endodontist using local anaesthesia and rubber-dam isolation.
Participants. Adults (18 years or older) with single-rooted, single-canal teeth diagnosed with asymptomatic apical periodontitis on periapical radiographs were eligible. Exclusion criteria included symptomatic apical periodontitis or acute abscess, previous root-canal treatment of the study tooth, systemic conditions interfering with pain assessment or requiring antibiotic prophylaxis, pregnancy or lactation, known allergy to study materials, and use of analgesics or anti-inflammatory drugs within 12 hours before treatment. One patient contributed one tooth.
Randomization, allocation concealment, and masking. Participants were randomized 1:1 to OCT or CHX using computer-generated permuted blocks with stratification by baseline pain (NRS \<= 3 vs > 3). Allocation was concealed with sequentially numbered, opaque, sealed envelopes. Irrigants were prepared by a third party in identical opaque syringes labelled A/B. Participants, the care provider (operator), and the outcomes assessor were blinded until database lock.
Interventions. Working length was established with an electronic apex locator and confirmed radiographically when needed. Root canals were prepared with nickel-titanium rotary instruments to size 40/0.04. During shaping, 5.25 percent sodium hypochlorite was used (approximately 2 mL after each instrument change). The smear layer was removed with 17 percent EDTA (about 10 mL) activated with a sonic device, followed by saline. For the final irrigation, the allocated solution was delivered and sonically activated using the same protocol in both groups: OCT 0.1 percent or CHX 2 percent, activated in three 20-second cycles with the solution refreshed with 2 mL between cycles (approximate total 6 mL). A side-vented needle was placed short of the working length. Root-canal obturation was completed in the same session using gutta-percha and an epoxy resin-based sealer with cold lateral compaction. Access cavities were restored with a resin composite. Rescue analgesics were permitted as needed and recorded by patients.
Outcomes. Primary outcome: patient-reported pain on the 0-10 NRS at 48 hours after treatment. Secondary outcomes: NRS pain at 6, 12, and 24 hours; total rescue analgesic consumption from 0 to 48 hours; and unplanned urgent care or adverse events within 48 hours.
Sample size and analysis plan. The a priori sample-size calculation assumed a between-group difference of 1.0 NRS unit (SD 2.0), alpha 0.05, and power 0.80, yielding 100 participants; allowing for attrition, the target was 120. Analyses compared groups at 48 hours and evaluated pain trajectories over time using mixed-effects methods with fixed effects for group and time and a random intercept for participant. Two-sided p \< 0.05 was considered statistically significant.
Oversight. The protocol was approved by the Bezmialem Vakif University Clinical Research Ethics Committee (approval E.99606). The trial was conducted in accordance with the Declaration of Helsinki.
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This study's enrollment of 142 is above the median of 60 across 211 interventional studies indexed under Periapical Periodontitis.
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Exclusion Criteria:
Single-visit root canal treatment with octenidine dihydrochloride 0.1% as the final irrigant. The irrigant was sonically activated using three 20-second cycles; the solution was refreshed with 2 mL between cycles (approximate total 6 mL). Delivery through a side-vented needle positioned short of the working length. The final irrigant was administered once, during the final irrigation phase. All other procedural steps were identical to the comparator arm.
Drug: Octenidine dihydrochloride 0.1%
Single-visit root canal treatment with chlorhexidine 2% as the final irrigant. The irrigant was sonically activated using the same protocol as the experimental arm: three 20-second cycles with the solution refreshed with 2 mL between cycles (approximate total 6 mL). Delivery through a side-vented needle positioned short of the working length. The final irrigant was administered once, during the final irrigation phase. All other procedural steps were identical to the experimental arm.
Drug: Chlorhexidine 2%
Final intracanal irrigant (aqueous solution); single administration during the final irrigation phase. Sonic activation performed in three 20-second cycles; solution refreshed with 2 mL between cycles (approximate total 6 mL per canal). Delivered through a side-vented needle positioned short of the working length.
Also known as: OCT; Octenidine 0.1% solution
Final intracanal irrigant (aqueous solution); single administration during the final irrigation phase. Sonic activation performed in three 20-second cycles; solution refreshed with 2 mL between cycles (approximate total 6 mL per canal). Delivered through a side-vented needle positioned short of the working length.
Also known as: CHX; Chlorhexidine 2% solution
Pain at 48 hours (NRS 0-10)
Patient-reported pain on the 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst pain). Higher scores indicate worse pain. Assessed using a patient diary. Analysis compares OCT vs CHX at 48 hours; analysis population includes all randomized participants with an available 48 h NRS value.
Time frame: 48 hours after treatment
Pain at 6 hours (NRS 0-10)
Patient-reported NRS pain score (0 = no pain, 10 = worst pain). Higher scores indicate worse pain. Assessed using a patient diary; between-group comparison at 6 hours.
Time frame: 6 hours after treatment
Pain at 12 hours (NRS 0-10)
Patient-reported NRS pain score (0 = no pain, 10 = worst pain). Higher scores indicate worse pain. Assessed using a patient diary; between-group comparison at 12 hours.
Time frame: 12 hours after treatment
Pain at 24 hours (NRS 0-10)
Patient-reported NRS pain score (0 = no pain, 10 = worst pain). Higher scores indicate worse pain. Assessed using a patient diary; between-group comparison at 24 hours.
Time frame: 24 hours after treatment
Rescue analgesic consumption (0-48 hours)
Number of self-reported rescue analgesic doses taken from 0 to 48 hours after treatment (any medication allowed per routine care). Participants recorded type, dose, and timing in a diary. Higher counts indicate greater analgesic use.
Time frame: 0 to 48 hours after treatment
Unplanned urgent care within 48 hours
Count of participants who required unplanned urgent dental care (eg, unscheduled clinic visit or phone consultation requiring prescription) within 48 hours after treatment. Reported as number and proportion of participants.
Time frame: Up to 48 hours after treatment
Adverse events within 48 hours (postoperative flare-up and other events)
Occurrence of any adverse event within 48 hours after treatment, including postoperative flare-up requiring unplanned care. Reported as number and proportion of participants with at least one event; serious and non-serious events summarized separately.
Time frame: Up to 48 hours after treatment
Analgesic-free participants (0-48 hours)
Proportion of participants who took no rescue analgesics from 0 to 48 hours after treatment (yes/no).
Time frame: 0 to 48 hours after treatment
Plan to share: No
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Bezmialem Vakif University