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CompletedNCT06088446Updated Oct 19, 2023

Effect of Intrapulpal Injections on the Post-endodontic Pain

An interventional study of Supplementary anesthetic injections in Pulpitis - Irreversible, sponsored by Jamia Millia Islamia. Completed at 1 site in India. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-19.

Sponsored by Jamia Millia Islamia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

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Conditions studied

  • Pulpitis - Irreversible

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03

In context

Pulpitis

302 studies on the registry are indexed under Pulpitis; 67 are open to participants now.

This study's enrollment of 108 is above the median of 62 across 275 interventional studies indexed under Pulpitis.

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Lead sponsor

Jamia Millia Islamia is the lead sponsor of 11 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
108 participants (actual)

Study arms

  • Active comparator
    Supplementary Intrapulpal injection

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

    Procedure: Supplementary anesthetic injections

  • 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

Interventions

  • ProcedureSupplementary anesthetic injections

    Supplementary anesthetic injections after failed primary nerve block

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What researchers measure

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

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

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Study locations

1 site
  • Faculty of Dentistry, Jamia MIliia Islamia
    New Delhi, 110025, India
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06088446
Lead sponsor
Jamia Millia Islamia
Responsible party
Dr. Vivek Aggarwal (Professor, Jamia Millia Islamia) — Principal investigator
First posted
Oct 18, 2023
Start date
Jul 5, 2023
Primary completion
Oct 3, 2023
Completion
Oct 3, 2023
Last update
Oct 19, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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