Using different sodium hypochlorite concentrations in 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
NA · Ataturk University · NCT07453576
This study will test whether using 1%, 2.5%, or 5.25% sodium hypochlorite during root canal retreatment changes levels of pain-related molecules inside the canal and affects postoperative pain in adults needing retreatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ataturk University (other) |
| Locations | 1 site (Erzurum, Erzurum) |
| Trial ID | NCT07453576 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, single-center trial enrolling adults who require non-surgical root canal retreatment. After removal of previous root filling material, intracanal fluid samples are taken before and after irrigation with one of three sodium hypochlorite concentrations (1%, 2.5%, 5.25%). Neuropeptide levels (Substance P, CGRP, Opiorphin) will be quantified by ELISA, and patients will record postoperative pain using a visual analog scale at predefined time points. The study compares biochemical changes in the canal with clinical pain outcomes to clarify links between irrigant concentration, inflammatory mediators, and pain.
Who should consider this trial
Good fit: Adults aged 18–65 who are systemically healthy (ASA I–II) and need non-surgical root canal retreatment of a previously treated permanent tooth and can provide informed consent are the ideal candidates.
Not a fit: Patients with systemic conditions affecting pain or inflammation, recent use of analgesics/antibiotics, pregnancy or lactation, teeth with fractures/perforations/open apices, acute abscess with swelling, allergy to sodium hypochlorite, or inability to attend follow-up are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could help dentists choose an irrigant concentration that reduces inflammatory mediators and lowers postoperative pain after root canal retreatment.
How similar studies have performed: Previous work has shown that higher sodium hypochlorite concentrations can increase antimicrobial effects and influence postoperative pain, but measuring intracanal Substance P, CGRP, and Opiorphin in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Erzurum, Erzurum
- Atatürk University Faculty of Dentistry, Department of Endodontics — Erzurum, Erzurum, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: KEZBAN MELTEM ÇOLAK — Atatürk University, Faculty of Dentistry, Department of Endodontics
- Study coordinator: KEZBAN MELTEM ÇOLAK, Prof. Dr
- Email: meltem25@gmail.com
- Phone: +905325744027
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Persistent Apical Periodontitis, Root Canal Retreatment, Sodium Hypochlorite, Substance P, CGRP, Opiorphin, Postoperative Pain