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NCT Number: NCT06194721

The Effect of Intra-pulpal Anesthesia With Cryotherapy on Intra-operative Pain

The goal of this clinical trial is to compare the effect of cooling of local anesthesia on intraoperative pain during root canal treatment in mandibular molars diagnosed as symptomatic irreversible pulpitis. The main question it aims to answer is: Is there a difference in intra-operative pain levels using intra-pulpal anesthesia with and without cryotherapy during root canal treatment? Participants will undergo root canal treatment using intrapulpal anesthesia with and without cooling. Researchers will compare cold and room temperature intrapulpal anesthesia to see the intensity of intraoperative pain.

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Key information

Conditions

Irreversible Pulpitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulf Medical University

Ajman, 4184, United Arab Emirates

About this study

The study will be conducted on 40 mandibular molars in each group n = 20. The patient will be asked to pick an opaque sealed envelope that will contain a number 1 or 2. The resultant number will determine in which group the participants will be placed. Double blinding will be maintained in this study as the assessor and the patients will not be aware of their group.

Group 1: Will receive intrapulpal local anesthesia at 4-5 C after pulp exposure.

Group 2: Will receive intrapulpal local anesthesia at room temperature after pulp exposure.

Procedural steps:

  • A history of present illness will be recorded from the patient and the suspected tooth will be tested for vitality using a cold test and an electric pulp tester, to ensure the correct diagnosis is reached.
  • Once the diagnosis is confirmed to be symptomatic irreversible pulpitis, the patient will receive an inferior alveolar nerve block (2% lidocaine 1:100,000).
  • A rubber dam will be used to achieve isolation, and an access cavity will be prepared using a high-speed handpiece, a round bur (no.4), and an Endo-Z bur.
  • If the patient reports feeling any pain, the procedure will stop, and the patient will be presented with a Visual Analogue Scale and asked to rate the pain on a scale of 1-10. Pain levels of more than 5 will be included in the study.
  • Intra-pulpal anesthesia (2% lidocaine 1:100,000) will be administered, and the needle will be surrounded by a piece of sterile gauze to ensure it is under back pressure.
  • After administering the intra-pulpal injection, the patient will again be presented with the same VAS and asked to rate their current pain.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with mandibular molars diagnosed with symptomatic irreversible pulpitis.
  • Mandibular molars with closed apices.
  • Patients who are experiencing pain during access cavity drilling above 5 visual analog scale.

Exclusion criteria

  • • Patients with a known allergy to lidocaine.
  • Root canal-treated mandibular molars.
  • Patients with systemic diseases.
  • Mandibular molars with open apices.
  • Mandibular molars with external/internal resorption.
  • Non-restorable mandibular molars.

Treatment and study plan

Cold intrapulpal anesthesia

Procedure

Intrapulpal cold local anesthesia at 4-5 c temperature

Room temperature intrapulpal anesthesia

Procedure

Intrapulpal cold local anesthesia at room temperature

Primary outcomes

  1. Level of intraoperative pain

    Time frame: Intraoperative

    Evaluation of intraoperative pain intensity using a visual analog scale. The visual analog scale measures pain intensity. The visual analog scale consists of a 10 cm line, with 2 endpoints representing 0 ( no pain) and 10 (pain as bad it could be)

Sponsors and collaborators

Lead sponsor

Gulf Medical University

Other

Registry information

Official study title

The Effect of Intra-pulpal Anesthesia With Cryotherapy on Intra-operative Pain During Root Canal Treatment on Mandibular Molars With Symptomatic Irreversible Pulpitis

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 8, 2024
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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