Postoperative Pain After OCT or EDTA Irrigation in Regenerative Endodontic Treatment

NCT07722416 | Completed DMC

• 1 other identifier: 2026/192
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Apical Periodontitis; Endodontic Disease

Keywords

apical periodontitis; immature permanent teeth; octenidine dihydrochloride; postoperative pain; regenerative endodontic treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative Analgesic Consumption

  At 6, 12, and 24 hours and daily from Day 2 through Day 7 after the second treatment visit

Study Arms (2)

17% Ethylenediaminetetraacetic Acid (EDTA)

ACTIVE COMPARATOR

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

0.1% Octenidine Dihydrochloride (OCT)

ACTIVE COMPARATOR

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

Interventions

Regenerative Endodontic Treatment Using Different Irrigation Solutions OTHER

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.

0.1% Octenidine Dihydrochloride (OCT); 17% Ethylenediaminetetraacetic Acid (EDTA)

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes Üniversitesi Diş Hekimliği Fakültesi

Kayseri, Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis; Dental Pulp Diseases; Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This was a participant-blinded trial. Participants were not informed of the irrigant assigned to their treatment. The treating clinicians could not be blinded because they administered the allocated irrigant. Postoperative pain was self-recorded by the participants using standardized forms, and intervention group codes were concealed during statistical analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ARŞ.GÖR

Model Details: Participants were randomized in a 1:1 ratio to one of two parallel intervention arms. One arm received 0.1% octenidine dihydrochloride, and the other arm received 17% ethylenediaminetetraacetic acid during regenerative endodontic treatment. Each participant remained in the assigned intervention arm throughout the study.

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: October 1, 2025
• Primary Completion: May 8, 2026
• Study Completion: May 8, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)