Effect of Intrapulpal Injections on the Post-endodontic Pain

Sponsor
Jamia Millia Islamia (Other)
Overall Status
Completed
CT.gov ID
NCT06088446
Collaborator
(none)
108
1
2
3
36.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Supplementary anesthetic injections
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Intrapulpal Injections on the Post-endodontic Pain in Patients With Symptomatic Irreversible Pulpitis
Actual Study Start Date :
Jul 5, 2023
Actual Primary Completion Date :
Oct 3, 2023
Actual Study Completion Date :
Oct 3, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
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:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry, Jamia MIliia Islamia New Delhi India 110025

Sponsors and Collaborators

  • Jamia Millia Islamia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Vivek Aggarwal, Professor, Jamia Millia Islamia
ClinicalTrials.gov Identifier:
NCT06088446
Other Study ID Numbers:
  • Intrapulpal
First Posted:
Oct 18, 2023
Last Update Posted:
Oct 19, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2023