Effects of Intracanal Cryotherapy on Endodontic Postoperative Pain

NCT ID: NCT05611736

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 302 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-01-14

Brief Summary

The goal of this clinical trial is to evaluate the effect of cold saline (2.5 degrees Celsius) irrigation on postoperative pain in patients who require root canal treatment in molar teeth because of dead dental pulp and infection around the apex of the root of the involved teeth. This cold saline irrigation will be done after standard irrigation of the canal using a 5.25% sodium hypochlorite solution. The main questions it aims to answer are:

• Is there any difference in postoperative pain when final irrigation is performed using a cold saline solution compared to the irrigation using the saline solution at room temperature in patients who require dental root canal treatment of molar teeth?
• Because of cold saline irrigation, what type of adverse event/s may result?

Participants will be asked to fill out a questionnaire before the start of the root canal treatment and record the preoperative pain using the visual analog scale (VAS). Root canal treatment will be completed in one visit. The standard procedure of root canal treatment will be followed, including irrigation of the canal using 5.25% sodium hypochlorite. As a final irrigation, either cold saline solution or a normal saline solution at room temperature will be used. The participants will be asked to fill out another questionnaire and record the presence, duration, and intensity of postoperative pain, and if painkiller medicine was taken immediately after completion of root canal treatment and at 6 hours, 12 hours, 72 hours, and 1-week intervals.

The researcher will compare the effect of the final irrigation of a cold saline solution with that of a normal saline solution at room temperature on postoperative pain.

Detailed Description

Postoperative pain in root canal therapy is multifactorial in nature, including changes in periapical pressure, microbial factors, inflammatory mediators, and psychological factors. Postoperative pain in endodontics between visits or after completion of the treatment is a major concern to both patients and operators. Teeth presented with preoperative pain, irreversible pulpitis, pulp necrosis, and apical periodontitis are the most susceptible to postoperative pain The pharmacological management of pain using medications such as nonsteroidal anti-inflammatory drugs, paracetamol, or corticosteroids, despite being relatively safe, can have side effects such as gastrointestinal intolerance and renal, hepatic, and respiratory disorders such as asthma which have been reported in the literature. To avoid these secondary effects, intracanal medications, laser, and cryotherapy have been suggested in the literature.

Physical and clinical evidence suggests that the application of cold may decrease pain through the mechanism of decreasing the conduction velocity of nerve signals, hemorrhage, edema, and local inflammation. An in vitro study showed that intracanal irrigation with cold saline at 2.5 degrees Celsius reduced the external root surface temperature by more than 10 degrees Celsius, which would be enough to produce the anti-inflammatory effect in peri-radicular tissues.

There are very few studies done to evaluate the effect of intracanal cryotherapy on postoperative pain in root canal therapy.

This clinical trial aims to assess if final irrigation using cold saline solution after standard chemo-mechanical preparation (root canal instrumentation and irrigation using 5.25% sodium hypochlorite) procedures results in any difference in the incidence and intensity of postoperative pain in patients presenting with molar teeth with necrosis of pulp and symptomatic apical periodontitis. This clinical trial will also assess the incidence of any adverse event as a result of cold saline irrigation.

Conditions

Dental Pulp Necroses; Apical Periodontitis; Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

cold saline

After standard chemo-mechanical preparation of the root canal, final irrigation will be performed using 20 milliliters of cold (at 2.5 degrees Celsius temperature) saline solution.

Group Type: EXPERIMENTAL

cold saline

Intervention Type: OTHER

After standard chemo-mechanical preparation of the root canal, final irrigation will be performed using 20 milliliters of cold (at 2.5 degrees Celsius temperature) saline solution.

saline

After standard chemo-mechanical preparation of the root canal, final irrigation of the root canal system will be performed using 20 milliliters of normal saline solution at room temperature.

Group Type: ACTIVE_COMPARATOR

saline

Intervention Type: OTHER

After standard chemo-mechanical preparation of the root canal, final irrigation of the root canal will be done using normal saline solution at room temperature

Interventions

cold saline

After standard chemo-mechanical preparation of the root canal, final irrigation will be performed using 20 milliliters of cold (at 2.5 degrees Celsius temperature) saline solution.

Intervention Type: OTHER

saline

After standard chemo-mechanical preparation of the root canal, final irrigation of the root canal will be done using normal saline solution at room temperature

Intervention Type: OTHER

Other Intervention Names

cold normal saline; normal saline

Eligibility Criteria

Inclusion Criteria

• Healthy patients
• Patients with maxillary or mandibular molar teeth that require root canal treatment
• The diagnosis of pulp necrosis
• The presence of symptomatic apical periodontitis
• The presence of normal occlusion

Exclusion Criteria

• Previously done root canal treatment
• Pregnancy
• Presence of any systemic disease or allergic reactions
• Use of any analgesic or antibiotic medications within the past three days
• Sinus tract or local gingival swelling around the affected tooth
• Periodontal pocket greater than 3 mm around the affected tooth
• Severe periodontal disease
• Internal or external root resorption
• Broken files
• Over instrumentation
• Incomplete filling of the root canal
• Overfilling of the root canal

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qassim University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Zubair Ahmad

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammad Zubair Ahmad, BDS, FCPS

Role: PRINCIPAL_INVESTIGATOR

Qassim University

Locations

Muhammad Zubair Ahmad

Ar Rass, Al-Qassim Region, Saudi Arabia

Countries

Saudi Arabia

References

Vera J, Ochoa-Rivera J, Vazquez-Carcano M, Romero M, Arias A, Sleiman P. Effect of Intracanal Cryotherapy on Reducing Root Surface Temperature. J Endod. 2015 Nov;41(11):1884-7. doi: 10.1016/j.joen.2015.08.009. Epub 2015 Oct 1.

Reference Type: BACKGROUND

PMID: 26433855 (View on PubMed)

Alharthi AA, Aljoudi MH, Almaliki MN, Almalki MA, Sunbul MA. Effect of intra-canal cryotherapy on post-endodontic pain in single-visit RCT: A randomized controlled trial. Saudi Dent J. 2019 Jul;31(3):330-335. doi: 10.1016/j.sdentj.2019.03.004. Epub 2019 Mar 14.

Reference Type: BACKGROUND

PMID: 31337936 (View on PubMed)

Fayyad DM, Abdelsalam N, Hashem N. Cryotherapy: A New Paradigm of Treatment in Endodontics. J Endod. 2020 Jul;46(7):936-942. doi: 10.1016/j.joen.2020.03.019. Epub 2020 May 6.

Reference Type: BACKGROUND

PMID: 32386857 (View on PubMed)

Sadaf D. Limited Quality Evidence Suggests that Application of Cryotherapy May Be Helpful in Reducing Postoperative Pain in Root Canal Therapy in Patients With Symptomatic Apical Periodontitis. J Evid Based Dent Pract. 2019 Jun;19(2):195-197. doi: 10.1016/j.jebdp.2019.05.005. Epub 2019 May 6.

Reference Type: BACKGROUND

PMID: 31326055 (View on PubMed)

Gundogdu EC, Arslan H. Effects of Various Cryotherapy Applications on Postoperative Pain in Molar Teeth with Symptomatic Apical Periodontitis: A Preliminary Randomized Prospective Clinical Trial. J Endod. 2018 Mar;44(3):349-354. doi: 10.1016/j.joen.2017.11.002. Epub 2018 Feb 3.

Reference Type: BACKGROUND

PMID: 29398090 (View on PubMed)

Sadaf D, Ahmad MZ, Onakpoya IJ. Effectiveness of Intracanal Cryotherapy in Root Canal Therapy: A Systematic Review and Meta-analysis of Randomized Clinical Trials. J Endod. 2020 Dec;46(12):1811-1823.e1. doi: 10.1016/j.joen.2020.08.022. Epub 2020 Sep 8.

Reference Type: BACKGROUND

PMID: 32916207 (View on PubMed)

Vera J, Ochoa J, Romero M, Vazquez-Carcano M, Ramos-Gregorio CO, Aguilar RR, Cruz A, Sleiman P, Arias A. Intracanal Cryotherapy Reduces Postoperative Pain in Teeth with Symptomatic Apical Periodontitis: A Randomized Multicenter Clinical Trial. J Endod. 2018 Jan;44(1):4-8. doi: 10.1016/j.joen.2017.08.038. Epub 2017 Nov 1.

Reference Type: BACKGROUND

PMID: 29079057 (View on PubMed)

Ahmad MZ. Effects of intracanal cryotherapy on postoperative pain in necrotic teeth with symptomatic apical periodontitis: a randomized controlled clinical trial. Front Dent Med. 2025 Apr 14;6:1543383. doi: 10.3389/fdmed.2025.1543383. eCollection 2025.

Reference Type: DERIVED

PMID: 40297278 (View on PubMed)

Other Identifiers

21-19-08

Identifier Type: -

Identifier Source: org_study_id