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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Sodium 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.
• Препарат Sodium 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.
• Препарат Sodium 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).

Первичные конечные точки

• Change in Intracanal Substance P, CGRP, and Opiorphin Levels [Срок оценки: Before irrigation and immediately after irrigation during the same treatment session]
• Change in Intracanal Substance P, CGRP, and Opiorphin Levels [Срок оценки: Before irrigation and immediately after irrigation during the same treatment session]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Atatürk University Faculty of Dentistry, Department of Endodontics — Erzurum

Идентификаторы

NCT: NCT07453576 · B.30.2.ATA.0.01.00/698

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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