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

NCT07173725 | Completed

• 1 other identifier: 08.03.2023-E.99606
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Apical Periodontitis; Postoperative Pain

Keywords

Endodontics; Root canal treatment; Final irrigant; Single-visit endodontics; Chlorhexidine; Octenidine

Outcome Measures

Primary Outcomes (1)

• 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.

  48 hours after treatment

Secondary Outcomes (6)

• Pain at 6 hours (NRS 0-10)

  6 hours after treatment

• Pain at 12 hours (NRS 0-10)

  12 hours after treatment

• Pain at 24 hours (NRS 0-10)

  24 hours after treatment

• Rescue analgesic consumption (0-48 hours)

  0 to 48 hours after treatment

• Unplanned urgent care within 48 hours

  Up to 48 hours after treatment

Other Outcomes (1)

• Analgesic-free participants (0-48 hours)

  0 to 48 hours after treatment

Study Arms (2)

Octenidine 0.1% final irrigant

EXPERIMENTAL

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%

Chlorhexidine 2% final irrigant

ACTIVE COMPARATOR

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%

Interventions

Octenidine dihydrochloride 0.1% DRUG

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

Octenidine 0.1% final irrigant

Chlorhexidine 2% DRUG

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

Chlorhexidine 2% final irrigant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University Dental Hospital - Department of Endodontics

Istanbul, 34093, Turkey (Türkiye)

Location

Related Links

• Bezmialem Vakif University - study site

MeSH Terms

Conditions

Periapical Periodontitis; Pain, Postoperative

Interventions

octenidine; Solutions; Chlorhexidine

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• fatma B peker, dds

  Department of Endodontics, Bezmialem Vakif University, Istanbul, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Irrigants prepared by a third party in identical opaque A/B syringes; allocation concealed with SNOSE; participants, care provider (operator), and outcomes assessor were blinded; A/B code broken only after database lock.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, parallel-group, single-centre endodontic trial; single-visit treatment; final irrigant: octenidine vs chlorhexidine.

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: March 8, 2023
• Primary Completion: October 18, 2024
• Study Completion: July 20, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)