Clinical trial NCT06820996: Effect of Cryotreated Sodium Hypochlorite Irrigation At Different Consentrations in Mandibular First Molars
Official title: Effect of Cryotreated Sodium Hypochlorite Irrigation At Different Consentrations in Mandibular First Molars with Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulpitis - Irreversible
Keywords: Cryotherapy
Irreversible pulpits
Sodium hypochlorite
Postoperative pain
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial was to evaluate the effect of cryotreated sodium hypochlorite solution on the intensity of postoperative pain in root canal treatment procedures in mandibular first molar teeth with symptomatic irreversible pulpitis. The main question it aims to answer is:

- Does controlled irrigation with cold sodium hypochlorite in root canal treatment reduce the severity of postoperative pain? In the cryotreated NaOCl group, unlike the normal NaOCl group, the root canals were irrigated with 2 °C NaOCl solution.

Detailed description: Various irrigation solutions that are effective for organic and inorganic tissues are used during root canal treatment. Sodium hypochlorite (NaOCl) is the most commonly used irrigation solution. It has antibacterial and physicochemical properties 20 and is unique in dissolving organic tissues 21. NaOCl irrigation combined with mechanical instrumentation has been consistently shown to substantially reduce the microorganism load in root canals 22. There have been several attempts to increase the antimicrobial efficacy of NaOCl in the root canal system, such as changing its concentration, increasing the contact time with the dentin walls of the root canal, increasing the total volume of irrigation, increasing its temperature, and using manual or mechanical activation methods 3, 23. These methods to increase the efficacy of NaOCl can also result in heightened toxic effects on periapical tissues owing to the tissue-irritating properties of the solution. This extrusion into the periapical region increases postoperative pain, especially in teeth with open apices and necrotic pulps 21, 24. Therefore, instead of using high concentrations of NaOCl, which could increase its toxic effects, safer means, such as increasing its temperature and using it in large volumes, may increase its efficacy 21, 25.

Therefore, ascertaining the clinical impact of cryotreated NaOCl on postoperative pain is essential. The temperature of the irrigation solution is known to affect postoperative pain, and final irrigation with cold saline significantly reduces postoperative pain levels 19, 26. However, studies investigating the effects of cryotreated NaOCl, which is used in all stages of root canal treatment, and using NaOCl at concentrations of 2.5% and 5% on postoperative pain are lacking. This randomized clinical trial investigated the effects of cryotreated 2.5% and 5% NaOCl on postoperative pain during endodontic treatment procedures in mandibular first molars with symptomatic irreversible pulpitis.

Eligibility criteria: Inclusion Criteria:• Vital mandibular first molars with 3 root canals that responded positively to the cold test and electric pulp test

* Mandibular first molars with a preoperative VAS value of 4 and above (no pain (0 mm), mild pain (1-3 mm), moderate pain (4-6 mm), severe pain (7-10 mm))
* Teeth without periapical radiolucency seen radiographically
* Patients who did not take analgesics or antibiotics in the last 24 hours before the procedure were included in the study.

Exclusion Criteria:

* Devital teeth that responded negatively to cold tests and electric pulp tests,
* Teeth with poor periodontal status (pocket depth \> 4 mm),
* Mandibular first molars with 4 or more root canals detected radiographically or after opening the endodontic access cavity,
* Teeth with no preoperative pain or with mild preoperative pain (VAS value below 4) were excluded from the study.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
state: Sarıçam
Study officials:
affiliation: Cukurova Univercity
name: Koray Yılmaz, DDS MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nandakumar M, Nasim I. Effect of intracanal cryotreated sodium hypochlorite on postoperative pain after root canal treatment - A randomized controlled clinical trial. J Conserv Dent. 2020 Mar-Apr;23(2):131-136. doi: 10.4103/JCD.JCD_65_20. Epub 2020 Nov 5.
citation: Lalfakawmi S, Gupta A, Duraisamy AK, Abraham D, Mrinalini M, Mane AP. Impact of Cryotreated and Warm Sodium Hypochlorite on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial. J Endod. 2024 Nov;50(11):1543-1550. doi: 10.1016/j.joen.2024.07.002. Epub 2024 Jul 8.