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Completed

NCT Number: NCT06088446

Effect of Intrapulpal Injections on the Post-endodontic Pain

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.

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Key information

Conditions

Pulpitis - Irreversible

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Jamia MIliia Islamia

New Delhi, 110025, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supplementary anesthetic injections

Procedure

Supplementary anesthetic injections after failed primary nerve block

Primary outcomes

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

    Time frame: 6hours, 1 day, 3 days, 7 days

    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

Sponsors and collaborators

Lead sponsor

Jamia Millia Islamia

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 18, 2023
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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