Effect Of Different Sodium Hypochlorite Concentrations On Intracanal Substance P, CGRP And Opiorphin Levels And Postoperative Pain During Root Canal Retreatment

NCT07453576 | Recruiting

• 1 other identifier: B.30.2.ATA.0.01.00/698
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical study aims to evaluate the effect of different sodium hypochlorite concentrations (1%, 2.5%, and 5.25%) used during root canal retreatment on intracanal levels of Substance P, CGRP, and Opiorphin, as well as postoperative pain. Patients requiring non-surgical root canal retreatment will be randomly assigned to one of three irrigation concentration groups. Intracanal samples will be collected before and after irrigation to measure neuropeptide levels. Postoperative pain will be assessed using a visual analog scale (VAS) at predetermined time intervals. The results of this study may help clarify the relationship between irrigant concentration, inflammatory mediators, and postoperative pain following root canal retreatment.

Conditions

Persistent Apical Periodontitis

Keywords

Root Canal Retreatment; Sodium Hypochlorite; Substance P; CGRP; Opiorphin; Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• Change in Intracanal Substance P, CGRP, and Opiorphin Levels

  The primary outcome is the change in intracanal levels of Substance P, CGRP, and Opiorphin before and after irrigation with different sodium hypochlorite concentrations during non-surgical root canal retreatment. Neuropeptide levels will be quantified using ELISA.

  Before irrigation and immediately after irrigation during the same treatment session

• Change in Intracanal Substance P, CGRP, and Opiorphin Levels

  The primary outcome is the change in intracanal levels of Substance P, CGRP, and Opiorphin before and after irrigation with different sodium hypochlorite concentrations during non-surgical root canal retreatment. Neuropeptide levels will be quantified us

  Before irrigation and immediately after irrigation during the same treatment session

Study Arms (3)

1% Sodium Hypochlorite Irrigation

EXPERIMENTAL

Participants assigned to this arm will undergo non-surgical root canal retreatment using 1% sodium hypochlorite as the irrigating solution during chemomechanical preparation. Intracanal samples will be collected before and after irrigation to evaluate changes in Substance P, CGRP, and Opiorphin levels. Postoperative pain will be recorded using a visual analog scale (VAS) at predetermined time intervals.

Drug: Sodium Hypochlorite 1% Irrigation

2.5% Sodium Hypochlorite Irrigation

EXPERIMENTAL

Participants assigned to this arm will undergo non-surgical root canal retreatment using 2.5% sodium hypochlorite as the irrigating solution during chemomechanical preparation. Intracanal samples will be collected before and after irrigation to evaluate changes in Substance P, CGRP, and Opiorphin levels. Postoperative pain will be recorded using a visual analog scale (VAS) at predetermined time intervals.

Drug: Sodium Hypochlorite 2.5% Irrigation

5% Sodium Hypochlorite Irrigation

EXPERIMENTAL

Participants assigned to this arm will undergo non-surgical root canal retreatment using 5% sodium hypochlorite as the irrigating solution during chemomechanical preparation. Intracanal samples will be collected before and after irrigation to evaluate changes in Substance P, CGRP, and Opiorphin levels. Postoperative pain will be recorded using a visual analog scale (VAS) at predetermined time intervals.

Drug: Sodium Hypochlorite 5% Irrigation

Interventions

Sodium Hypochlorite 1% Irrigation DRUG

Irrigation with 1% sodium hypochlorite solution during chemomechanical preparation in non-surgical root canal retreatment. The solution will be used according to standardized irrigation protocols, and intracanal samples will be collected before and after irrigation for neuropeptide analysis.

1% Sodium Hypochlorite Irrigation

Sodium Hypochlorite 2.5% Irrigation DRUG

Irrigation with 2.5% sodium hypochlorite solution during chemomechanical preparation in non-surgical root canal retreatment. Intracanal samples will be collected before and after irrigation to evaluate changes in Substance P, CGRP, and Opiorphin levels.

2.5% Sodium Hypochlorite Irrigation

Sodium Hypochlorite 5% Irrigation DRUG

Irrigation with 5% sodium hypochlorite solution during chemomechanical preparation in non-surgical root canal retreatment. Intracanal samples will be obtained before and after irrigation, and postoperative pain will be assessed using a visual analog scale (VAS).

5% Sodium Hypochlorite Irrigation

Eligibility Criteria

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

You may qualify if:

• Patients aged between 18 and 65 years.
• Systemically healthy individuals (ASA I or II)
• Patients requiring non-surgical root canal retreatment of a previously treated permanent tooth
• Patients who provide written informed consent.

You may not qualify if:

• Patients with systemic diseases that may affect pain perception or inflammatory response.
• Use of analgesics, anti-inflammatory drugs, or antibiotics within 7 days prior to treatment.
• Pregnant or lactating women.
• Teeth with root fractures, perforations, advanced periodontal disease, or non-restorable teeth.
• Teeth with open apices or immature root development.
• Presence of acute apical abscess with swelling or sinus tract.
• Patients with known allergy to sodium hypochlorite.
• Inability to achieve adequate isolation with rubber dam.
• Patients unable to attend follow-up or complete pain assessment forms.

Sponsors & Collaborators

• KEZBAN MELTEM ÇOLAK: lead

Study Sites (1)

Atatürk University Faculty of Dentistry, Department of Endodontics

Erzurum, Erzurum, 25240, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sodium Hypochlorite; Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds; Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Officials

• KEZBAN MELTEM ÇOLAK

  Atatürk University, Faculty of Dentistry, Department of Endodontics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KEZBAN MELTEM ÇOLAK, Prof. Dr

CONTACT

+905325744027; meltem25@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to the sodium hypochlorite concentration used during retreatment. Laboratory personnel performing ELISA analysis and outcome assessors evaluating postoperative pain will also be blinded to group allocation. The clinician performing the procedure will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Endodontics

Model Details: Participants will be randomly assigned to one of three parallel groups according to the sodium hypochlorite concentration used during root canal retreatment (1%, 2.5%, or 5%). Each participant will receive only one irrigation protocol.

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)