Effect of Intra-Canal Cryotherapy on Postoperative Pain After Endodontic Procedures

NCT06134713 | Unknown Phase 4

• 1 other identifier: D-F-H-30-NOV
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomised clinical trial is to evaluate the effect of cryotherapy on postoperative pain after primary and secondary root canal treatment. The main question\[s\] it aims to answer are:

• Dose cryotherapy help reduce postoperative pain after primary root canal treatment.
• Dose cryotherapy help reduce postoperative pain after secondary root canal treatment. Participants will be randomly divided to receive either cryotherapy or irrigation with normal saline and the effect between the two groups in terms of postoperative pain will be compared after primary and secondary root canal treatment.

Conditions

Endodontically Treated Teeth; Post Operative Pain

Keywords

Root Canal Treatment; Post Operative Pain; Cryotherapy; Nonsurgical Root Canal Retreatment

Outcome Measures

Primary Outcomes (1)

• Postoperative pain assessment using the visual analog scale (VAS)

  Both pre- and postoperative pain will be assessed using the visual analog scale (VAS). According to the quantitative data obtained from the VAS scale (from 1 to 10), these values will be categorized as follows: no pain (0), slight pain (0.1-3.9), moderate pain (4-6.9) or severe pain (7-10)

  Preoperative, 6 hours,12 hours, 24 hours, 48 hours, 72 hours, 5 days and 7 days

Study Arms (4)

Root canal treatment cryotherapy group

EXPERIMENTAL

Conventional root canal treatment with final irrigation using sterile saline at 2.5ºC

Drug: cryotherapy with sterile saline at 2.5ºC

Root canal RE-treatment cryotherapy group

EXPERIMENTAL

Conventional root canal RE-treatment with final irrigation using sterile saline at 2.5ºC

Drug: cryotherapy with sterile saline at 2.5ºC

Root canal treatment control group

ACTIVE COMPARATOR

Conventional root canal treatment with final irrigation using sterile saline at room temperature

Drug: control with sterile saline at room temperature

Root canal RE-treatment control group

ACTIVE COMPARATOR

Conventional root canal RE-treatment with final irrigation using sterile saline at room temperature

Drug: control with sterile saline at room temperature

Interventions

cryotherapy with sterile saline at 2.5ºC DRUG

In the cryotherapy (experimental group), final irrigation will be performed with 5 ml of 0.9% physiological sterile saline kept refrigerated at 2.5ºC and will be delivered for 1 or 4 minutes with a side vented needle inserted at working length for each canal.

Root canal RE-treatment cryotherapy group; Root canal treatment cryotherapy group

control with sterile saline at room temperature DRUG

In the control group, final irrigation will be performed with 5 ml of 0.9% physiological sterile saline kept at room temperature and will be delivered for 1 or 4 minutes with a side vented needle inserted at working length for each canal.

Root canal RE-treatment control group; Root canal treatment control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years.
• Patients who demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and who received a signed and dated copy of the informed consent form.
• Patients who understand and are willing to comply with all study procedures and restrictions.
• Absence of clinically significant and relevant abnormalities in the clinical history or oral examination.
• Endodontic treatment considered the treatment of choice for both multi and single rooted teeth.
• Endodontic retreatment considered the treatment of choice only in posterior molar teeth (multirooted).
• Only one treatment per patient.

You may not qualify if:

• Patients who are allergic to any of the materials used in the treatment.
• Patients with heart pacemaker.
• Patients with any general pathology that requires antibiotic prophylaxis.
• Root resorption, root fractures, impossibility of restoration.
• Pregnant patients.
• Patients who took painkillers in the last 6 hours.
• Case where apical patency couldn't be achieved
• Cases where final obturation quality is compromised.
• Any intra operative factor that complication that can compromise the treatment outcome like root perforation or fractured instrument or inability to localize/prepare any canal.

Sponsors & Collaborators

• Ajman University: lead
• Universitat Internacional de Catalunya: collaborator

Study Sites (1)

Ajman University

Ajman, United Arab Emirates

Location

MeSH Terms

Conditions

Tooth, Nonvital; Pain, Postoperative

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Firas H Elmsmari, PhD

  Ajman University - College of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 18, 2023
• Study Start: May 15, 2023
• Primary Completion: February 28, 2024
• Study Completion: May 30, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

AE (1)