Effect of Intrapulpal Injections on the Post-endodontic Pain

Effect of Intrapulpal Injections on the Post-endodontic Pain in Patients With Symptomatic Irreversible Pulpitis

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.

Study Overview

• Status: Completed
• Conditions: Pulpitis - Irreversible
• Intervention / Treatment: Procedure: Supplementary anesthetic injections

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • New Delhi, India, 110025
    • Faculty of Dentistry, Jamia MIliia Islamia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Supplementary Intrapulpal injection; Supplementary Intrapulpal injections were given using a 30-gauze needle with sufficient back pressure.	Procedure: Supplementary anesthetic injections; Supplementary anesthetic injections after failed primary nerve block
Active Comparator: Intraligamentary injection; Intraligamentary injections were given using an intraligamentary syringe with back-pressure after a failed primary inferior alveolar nerve block.	Procedure: Supplementary anesthetic injections; Supplementary anesthetic injections after failed primary nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jamia Millia Islamia

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Actual): October 3, 2023
• Study Completion (Actual): October 3, 2023

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 15, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: Intrapulpal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No