Effect Of Different Sodium Hypochlorite Concentrations On Intracanal Substance P, CGRP And Opiorphin Levels And Postoperative Pain During Root Canal Retreatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sodium Hypochlorite 1% Irrigation, Sodium Hypochlorite 2.5% Irrigation, Sodium Hypochlorite 5% Irrigation.
- Who it may be relevant to
- Registry conditions: Persistent Apical Periodontitis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
- Drug 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. - Drug 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. - Drug 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).
Primary outcome measures
- Change in Intracanal Substance P, CGRP, and Opiorphin Levels [Time frame: Before irrigation and immediately after irrigation during the same treatment session]
- Change in Intracanal Substance P, CGRP, and Opiorphin Levels [Time frame: Before irrigation and immediately after irrigation during the same treatment session]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Atatürk University Faculty of Dentistry, Department of Endodontics — Erzurum
Identifiers
NCT: NCT07453576 · B.30.2.ATA.0.01.00/698