Postoperative Pain After OCT or EDTA Irrigation in Regenerative Endodontic Treatment | NCT07722416

NCT07722416

Overview

NCT ID: NCT07722416
Lead Sponsor: TC Erciyes UniversityOTHER
Official Title: Effect of Different Irrigation Protocols on Postoperative Pain Following Regenerative Endodontic Treatment: A Randomized Clinical Trial
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

Status and Timeline

Status: Completed
Last Update Posted: Jul 23, 2026Actual
Start Date: Oct 1, 2025Actual
Primary Completion Date: May 8, 2026Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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

Study Type: Interventional
Phase: Not Applicable
Enrollment: 40Actual
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: No data available
Locations: Erciyes Üniversitesi Diş Hekimliği Fakültesi

Similar Studies

Participant Group/Arms

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