Postoperative Pain After OCT or EDTA Irrigation in Regenerative Endodontic Treatment

Effect of Different Irrigation Protocols on Postoperative Pain Following Regenerative Endodontic Treatment: A Randomized Clinical Trial

This randomized clinical trial evaluated the effect of two different irrigation solutions on postoperative pain following regenerative endodontic treatment of necrotic immature permanent teeth with apical periodontitis. Participants were randomly allocated to receive either 0.1% octenidine dihydrochloride (OCT) or 17% ethylenediaminetetraacetic acid (EDTA) during regenerative endodontic treatment.

A total of 40 patients aged 9 to 16 years were included and allocated to the two intervention groups in a 1:1 ratio. Postoperative pain was recorded using a 0-100 numerical rating scale at 6, 12, and 24 hours and daily from the second through the seventh postoperative day. Analgesic use and the occurrence of flare-up were also evaluated.

Study Overview

• Status: Completed
• Conditions: Apical Periodontitis; Endodontic Disease
• Intervention / Treatment: Other: Regenerative Endodontic Treatment Using Different Irrigation Solutions

Detailed Description

Necrotic immature permanent teeth with apical periodontitis present a clinical challenge because incomplete root development is associated with thin dentinal walls, an open apex, and an increased risk of root fracture. Regenerative endodontic treatment is a biologically based procedure that aims to control intracanal infection, promote healing of the periapical tissues, and allow continued root development.

Successful regenerative endodontic treatment requires effective root canal disinfection while preserving an environment that supports the survival and activity of stem cells from the apical papilla. Ethylenediaminetetraacetic acid (EDTA) is commonly used in regenerative procedures because of its chelating properties, its ability to modify the dentin surface, and its potential to promote the release of dentin-derived bioactive molecules. Octenidine dihydrochloride (OCT) is a broad-spectrum antiseptic that has demonstrated antimicrobial activity and potentially favorable biological effects on dental-derived stem cells. However, clinical evidence regarding the use of OCT during regenerative endodontic treatment remains limited.

This prospective, participant-blinded, parallel-group randomized clinical trial included 40 systemically healthy patients aged 9 to 16 years who had a necrotic immature permanent tooth with apical periodontitis. Eligible teeth had Cvek stage 2 or 3 root development and a baseline Periapical Index score between 2 and 4. Each participant contributed one tooth to the study.

Participants were randomly assigned in a 1:1 ratio to one of two irrigation groups:

1. The OCT group received 0.1% octenidine dihydrochloride.
2. The EDTA group received 17% ethylenediaminetetraacetic acid.

Regenerative endodontic treatment was performed in two visits. During the first visit, the root canal was initially irrigated with 1.5% sodium hypochlorite. The allocated OCT or EDTA solution was then applied and ultrasonically activated. Calcium hydroxide was placed as an intracanal medicament, and the access cavity was temporarily sealed.

The second visit was performed approximately two weeks later. After removal of the intracanal medicament, the root canal was irrigated again according to the allocated protocol, and the irrigant was ultrasonically activated. Apical bleeding was induced to create an intracanal blood clot. Biodentine was placed over the blood clot as a coronal barrier, and the tooth was permanently restored with resin composite.

The primary outcome was postoperative pain intensity, which was recorded using a 0-100 numerical rating scale at 6, 12, and 24 hours and daily from day 2 through day 7 after the second treatment visit. Secondary outcomes included analgesic consumption and the occurrence of flare-up, defined as severe postoperative pain and/or swelling requiring an unscheduled clinical visit.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Kayseri
    • Kayseri, Kayseri, Turkey (Türkiye), 38039
      • Erciyes Üniversitesi Diş Hekimliği Fakültesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Systemically healthy status classified as American Society of Anesthesiologists class I;
• An immature permanent tooth with pulp necrosis and apical periodontitis;
• Cvek stage 2 or 3 root development;
• Preoperative pain below 40 on a 0-100 numerical rating scale (NRS);
• A baseline Periapical Index (PAI) score between 2 and 4;
• A tooth considered restorable and suitable for RET; and
• Willingness of the participant and legal representative to comply with postoperative assessment and follow-up requirements.

Exclusion Criteria:

• systemic disease
• bruxism or another parafunctional habit
• had used analgesics within 12 hours before treatment
• severe root canal curvature
• vertical root fracture

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 17% Ethylenediaminetetraacetic Acid (EDTA); Participants in this arm received standardized two-visit regenerative endodontic treatment. During both treatment visits, 20 mL of 17% ethylenediaminetetraacetic acid (EDTA) was applied to the root canal for 5 minutes and ultrasonically activated for 1 minute. Sodium hypochlorite, calcium hydroxide intracanal medication, induction of apical bleeding, placement of a Biodentine coronal barrier, and permanent restoration were standardized for both study groups.	Other: Regenerative Endodontic Treatment Using Different Irrigation Solutions; Regenerative endodontic treatment was performed using either 0.1% octenidine dihydrochloride (OCT) or 17% ethylenediaminetetraacetic acid (EDTA) as the allocated irrigation solution. In both groups, 20 mL of the assigned irrigant was applied for 5 minutes during each treatment visit and ultrasonically activated for 1 minute.
Active Comparator: 0.1% Octenidine Dihydrochloride (OCT); Participants in this arm received standardized two-visit regenerative endodontic treatment. During both treatment visits, 20 mL of 0.1% octenidine dihydrochloride (OCT) was applied to the root canal for 5 minutes and ultrasonically activated for 1 minute. Sodium hypochlorite, calcium hydroxide intracanal medication, induction of apical bleeding, placement of a Biodentine coronal barrier, and permanent restoration were standardized for both study groups.	Other: Regenerative Endodontic Treatment Using Different Irrigation Solutions; Regenerative endodontic treatment was performed using either 0.1% octenidine dihydrochloride (OCT) or 17% ethylenediaminetetraacetic acid (EDTA) as the allocated irrigation solution. In both groups, 20 mL of the assigned irrigant was applied for 5 minutes during each treatment visit and ultrasonically activated for 1 minute.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Intensity Measured Using a Numerical Rating Scale	Postoperative pain intensity was self-recorded by participants using a numerical rating scale ranging from 0 to 100, where 0 indicated no pain and 100 indicated the worst pain imaginable. Higher scores indicated greater postoperative pain intensity. Pain scores were recorded after the second regenerative endodontic treatment visit.	At 6, 12, and 24 hours and daily from Day 2 through Day 7 after the second treatment visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Analgesic Consumption	Participants were instructed to use paracetamol only when postoperative pain persisted. A dose of 250 to 500 mg was recommended according to the participant's age and body weight. The number of paracetamol tablets taken at each assessment time was recorded as 0, 1, or 2. Higher values indicated greater analgesic consumption.	At 6, 12, and 24 hours and daily from Day 2 through Day 7 after the second treatment visit

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Actual): May 8, 2026
• Study Completion (Actual): May 8, 2026

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: postoperative pain; regenerative endodontic treatment; apical periodontitis; immature permanent teeth; octenidine dihydrochloride
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Periapical Diseases; Jaw Diseases; Tooth Diseases; Periodontitis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Periapical Periodontitis; Dental Pulp Diseases
• Other Study ID Numbers: 2026/192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No