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

Effect Of Different Sodium Hypochlorite Concentrations (%1, %2.5, And %5) On Intracanal Substance P, CGRP, And Opiorphin Levels And Postoperative Pain During Root Canal Retreatment: A Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07453576
Acronym
NaOCl-NPP
Enrollment
60
Registered
2026-03-06
Start date
2025-10-01
Completion date
2027-02-01
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent Apical Periodontitis

Keywords

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

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.

Detailed description

This prospective, randomized, single-center clinical study is designed to investigate the effects of different sodium hypochlorite (NaOCl) concentrations (1%, 2.5%, and 5.25%) used during non-surgical root canal retreatment on intracanal levels of Substance P, calcitonin gene-related peptide (CGRP), and Opiorphin, as well as postoperative pain intensity. Patients diagnosed with teeth requiring root canal retreatment will be included according to predefined inclusion and exclusion criteria. Following access cavity preparation and removal of previous root canal filling material, intracanal samples will be obtained prior to irrigation. Participants will then be randomly allocated to one of three irrigation protocols using different NaOCl concentrations. A second intracanal sample will be collected after irrigation. Neuropeptide levels will be quantified using enzyme-linked immunosorbent assay (ELISA). Postoperative pain will be recorded using a visual analog scale (VAS) at specified time intervals following treatment. The primary outcome measures are the changes in intracanal Substance P, CGRP, and Opiorphin levels. The secondary outcome measure is postoperative pain intensity. This study aims to contribute to a better understanding of the biological and clinical effects of irrigant concentration during root canal retreatment.

Interventions

DRUGSodium Hypochlorite 1% Irrigation

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.

DRUGSodium Hypochlorite 2.5% Irrigation

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.

DRUGSodium Hypochlorite 5% Irrigation

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).

Sponsors

KEZBAN MELTEM ÇOLAK
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Intracanal Substance P, CGRP, and Opiorphin LevelsBefore irrigation and immediately after irrigation during the same treatment sessionThe 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTKEZBAN MELTEM ÇOLAK, Prof. Dr
meltem25@gmail.com+905325744027
PRINCIPAL_INVESTIGATORKEZBAN MELTEM ÇOLAK

Atatürk University, Faculty of Dentistry, Department of Endodontics

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026