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NCT Number: NCT07453576

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk University Faculty of Dentistry, Department of Endodontics

Erzurum, 25240, Turkey (Türkiye)

Location status: Recruiting

Location contact

GİZEM YAĞMUR ALMALI, DDS

CONTACT

[email protected]

+905535774333

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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).

Primary outcomes

  1. Change in Intracanal Substance P, CGRP, and Opiorphin Levels

    Time frame: Before irrigation and immediately after irrigation during the same treatment session

    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.

  2. Change in Intracanal Substance P, CGRP, and Opiorphin Levels

    Time frame: Before irrigation and immediately after irrigation during the same treatment session

    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

Study contacts

Contact information is provided by the study sponsor or research team.

KEZBAN MELTEM ÇOLAK, Prof. Dr

CONTACT

[email protected]

+905325744027

Sponsors and collaborators

Lead sponsor

KEZBAN MELTEM ÇOLAK

Other

Registry information

Official study title

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

Acronym: NaOCl-NPP

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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