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

NCT06194721 | Completed

• 1 other identifier: IRB-COD-STD-109-JUNE-2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cryotherapy

EXPERIMENTAL

Procedure: Cold intrapulpal anesthesia

Room temperature

ACTIVE COMPARATOR

Procedure: Room temperature intrapulpal anesthesia

Interventions

Cold intrapulpal anesthesia PROCEDURE

Intrapulpal cold local anesthesia at 4-5 c temperature

Cryotherapy

Room temperature intrapulpal anesthesia PROCEDURE

Intrapulpal cold local anesthesia at room temperature

Room temperature

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gulf Medical University: lead

Study Sites (1)

Gulf Medical University

Ajman, 4184, United Arab Emirates

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher at Thumbay Research Institute Coordinator

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: June 6, 2023
• Primary Completion: December 6, 2024
• Study Completion: January 6, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

AE (1)