Effects of Intracanal Cryotherapy on Endodontic Postoperative Pain

NCT05611736 | Completed

• 1 other identifier: 21-19-08
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Pulp Necroses; Apical Periodontitis; Post Operative Pain

Keywords

Cryotherapy; endodontic pain; molar teeth; root canal treatment

Outcome Measures

Primary Outcomes (10)

• Postoperative pain

  Postoperative pain will be measured using visual analog scale (VAS)

  6 hours postoperatively

• Postoperative pain

  Postoperative pain will be measured using visual analog scale (VAS)

  24 hours postoperatively

• Postoperative pain

  Postoperative pain will be measured using visual analog scale (VAS)

  72 hours postoperatively

• Postoperative pain

  Postoperative pain will be measured using visual analog scale (VAS)

  1 week postoperatively

• adverse event

  If any adverse event will occur, it will be recorded

  during the irrigation procedure

• adverse event

  If any adverse event will occur, it will be recorded

  immediately after the irrigation procedure

• adverse event

  If any adverse event will occur, it will be recorded

  6 hours postoperatively

• adverse event

  If any adverse event will occur, it will be recorded

  24 hours postoperatively

• adverse event

  If any adverse event will occur, it will be recorded

  72 hours postoperatively

• adverse event

  If any adverse event will occur, it will be recorded

  1 week postoperatively

Study Arms (2)

cold saline

EXPERIMENTAL

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.

Other: cold saline

saline

ACTIVE COMPARATOR

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.

Other: saline

Interventions

cold saline 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.

Also known as: cold normal saline

cold saline

saline 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

Also known as: normal saline

saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qassim University: lead

Study Sites (1)

Muhammad Zubair Ahmad

Ar Rass, Al-Qassim Region, 58883, Saudi Arabia

Location

Related Publications (8)

• 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.

  PMID: 26433855 BACKGROUND

• 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.

  PMID: 31337936 BACKGROUND

• 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.

  PMID: 32386857 BACKGROUND

• 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.

  PMID: 31326055 BACKGROUND

• 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.

  PMID: 29398090 BACKGROUND

• 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.

  PMID: 32916207 BACKGROUND

• 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.

  PMID: 29079057 BACKGROUND

• 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.

  PMID: 40297278 DERIVED

MeSH Terms

Conditions

Dental Pulp Necrosis; Periapical Periodontitis; Pain, Postoperative

Interventions

Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periapical Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Muhammad Zubair Ahmad, BDS, FCPS

  Qassim University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 10, 2022
• Study Start: June 1, 2022
• Primary Completion: January 14, 2024
• Study Completion: January 14, 2024
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

SA (1)