Effect of Intrapulpal Injections on the Post-endodontic Pain

NCT06088446 | Completed DMC

• 1 other identifier: Intrapulpal
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

To achieve painless treatment in patients with a failed primary IANB, supplementary anesthesia has been advised. The majority of the studies evaluating intrapulpal injections have been performed on asymptomatic teeth. Very limited research has been dedicated to the evaluation of different variables in intrapulpal injections in patients with symptomatic irreversible pulpitis. The aim of this study was to evaluate postoperative pain after an intrapulpal anesthesia injection given after a failed inferior alveolar nerve block (IANB), in patients with symptomatic irreversible pulpitis. This prospective, randomized, double-blind clinical trial was carried out at the Department of Conservative Dentistry and Endodontics, Faculty of Dentistry, Jamia Millia Islamia. One hundred and eight adult patients, with symptomatic irreversible pulpits in a mandibular first or second molar received an initial IANB with 2% lidocaine. Pain during the endodontic treatment was assessed using a visual analog scale (VAS). Patients experiencing pain on endodontic intervention were randomly allocated to one of the two treatment groups: one group received a supplementary intrapulpal injection while the other received a supplementary intraligamentary injection The presence of postoperative pain was assessed at 1, 2, 3, and 7 days after treatment.

Conditions

Pulpitis - Irreversible

Outcome Measures

Primary Outcomes (1)

• Post-endodontic pain using a visual analouge scale (VAS)

  Evaluation of numerical visual analouge pain scores after the completion of root canal treatment. The scale was 170mm long and the the values were continous and numerical. The 0 indicates no pain and 170 indicates the maximum possible pain

  6hours, 1 day, 3 days, 7 days

Study Arms (2)

Supplementary Intrapulpal injection

ACTIVE COMPARATOR

Supplementary Intrapulpal injections were given using a 30-gauze needle with sufficient back pressure.

Procedure: Supplementary anesthetic injections

Intraligamentary injection

ACTIVE COMPARATOR

Intraligamentary injections were given using an intraligamentary syringe with back-pressure after a failed primary inferior alveolar nerve block.

Procedure: Supplementary anesthetic injections

Interventions

Supplementary anesthetic injections PROCEDURE

Supplementary anesthetic injections after failed primary nerve block

Intraligamentary injection; Supplementary Intrapulpal injection

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Symptomatic carious exposed mandibular first or second molars.
• Positive and prolonged response to thermal sensitivity tests and electric pulp tests.
• Vital coronal pulp on access cavity preparation.
• American Society of Anesthesiologists class I or II medical history.
• Ability to understand the use of pain scales.

You may not qualify if:

• Active pain in more than 1 tooth.
• Teeth with fused roots.
• Radiographic evidence of an extra root.
• Large restorations with overhanging margins.
• Full crowns or deep periodontal pockets.
• Known allergy or contraindications to any content of the local anesthetic solution or NSAIDs
• History of known or suspected drug abuse.
• Taking any drugs which could affect the pain perception, e.g, opiods, antidepressants, anticonvulsants, muscle relaxants, anxiolytics, sedatives, nsaids. 23
• Pregnant or breastfeeding patients.
• Patients with asthma, gastric ulcers, and bleeding disorders.

Sponsors & Collaborators

• Jamia Millia Islamia: lead

Study Sites (1)

Faculty of Dentistry, Jamia MIliia Islamia

New Delhi, 110025, India

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: Professor

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 18, 2023
• Study Start: July 5, 2023
• Primary Completion: October 3, 2023
• Study Completion: October 3, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

IN (1)