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

Irreversible Pulpitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06194721
• Other study ID #: IRB-COD-STD-109-JUNE-2023
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2023
• Est. completion date: January 6, 2025

Study information

• Verified date: December 2023
• Source: Gulf Medical University
• Contact: Bassem M Eid, Ph.D.
• Phone: +971505145294
• Email: Dr.bassem[@]gmu.ac.ae
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

1. 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.

2. Once the diagnosis is confirmed to be symptomatic irreversible pulpitis, the patient will receive an inferior alveolar nerve block (2% lidocaine 1:100,000).

3. 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.

4. 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.

5. 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.

6. After administering the intra-pulpal injection, the patient will again be presented with the same VAS and asked to rate their current pain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 6, 2025
• Est. primary completion date: December 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irreversible Pulpitis
• Pulpitis

Intervention

Procedure:
• Cold intrapulpal anesthesia
Intrapulpal cold local anesthesia at 4-5 c temperature
• Room temperature intrapulpal anesthesia
Intrapulpal cold local anesthesia at room temperature

Locations

Country	Name	City	State
United Arab Emirates	Gulf Medical University	Ajman

Sponsors (1)

Lead Sponsor	Collaborator
Gulf Medical University

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of intraoperative pain	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)	Intraoperative