Two Approaches in Enhancing the Efficacy of Inferior Alveolar Nerve Block During Treatment of Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis

NCT05427903 | Unknown

• 1 other identifier: 602
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed as a randomized parallel controlled trial with three groups. Participants aged above 18 years with the first permanent molars with symptomatic signs of irreversible pulpitis will be randomly assigned into 3 groups. The first group (experimental group) will be injected with 4% articaine 1:100.000 epinephrine (inferior alveolar nerve block) will be anesthetized using 4% articaine 1:100.000 plus cryotherapy application, and the second group (experimental group) will be anaesthetised with IANB plus buccal infiltration. For the third group (control group), the mandibular molars will be anaesthetized using epinephrine using the inferior alveolar nerve block.

Conditions

Pain, Procedural

Outcome Measures

Primary Outcomes (1)

• Pain assessment

  verbal rating scale (VRS) withh the following scores: Score 0: no pain, Score 1: mild pain, Score 2: moderate pain, and Score 3: severe pain.

  up to 24 hours

Study Arms (3)

Cryotherapy

EXPERIMENTAL

Procedure: Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrine

IANB plus buccal infiltration local anesthesia

EXPERIMENTAL

Procedure: Cryotherapy

IANB

ACTIVE COMPARATOR

Procedure: Cryotherapy; Procedure: Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrine

Interventions

Cryotherapy PROCEDURE

Ice packs application for 5 minutes after IANB injection

IANB; IANB plus buccal infiltration local anesthesia

Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrine PROCEDURE

Buccal infiltration after IANB

Cryotherapy; IANB

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged above 18 years
• Presence of at least one mandibular first permanent molar, with signs and symptoms of irreversible pulpititis

You may not qualify if:

• Participants with a history of taking medications that could interfere with the action of the anaesthetic solutions
• Presence of paresthesia
• Presence of psychological problems
• Taking analgesics or other medications that would alter the inflammatory response of the pulp or provide analgesia 12 h pre-operatively

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University

Minya, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Procedural

Interventions

Cryotherapy; Epinephrine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Ahmad Elheeny, PhD

CONTACT

00201064257135; ahmedelheeny@mu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 22, 2022
• Study Start: March 4, 2022
• Primary Completion: June 18, 2022
• Study Completion: July 1, 2022
• Last Updated: June 22, 2022

Record last verified: 2022-06

Locations

EG (1)