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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Intracanal Substance P, CGRP, and Opiorphin Levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
1% Sodium Hypochlorite Irrigation
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.
干预措施: Sodium Hypochlorite 1% Irrigation (Drug)
2.5% Sodium Hypochlorite Irrigation
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.
干预措施: Sodium Hypochlorite 2.5% Irrigation (Drug)
5% Sodium Hypochlorite Irrigation
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.
干预措施: Sodium Hypochlorite 5% Irrigation (Drug)
结局指标
主要结局
Change in Intracanal Substance P, CGRP, and Opiorphin Levels
时间窗: 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.
次要结局
未报告次要终点
研究者
KEZBAN MELTEM ÇOLAK
Professor of Endodontics
Ataturk University