Intraligamentary Injections and Post-endodontic Pain

December 17, 2023 updated by: Dr. Vivek Aggarwal, Jamia Millia Islamia

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

This study will aim to evaluate postoperative pain after intraligamentary injections of dexamethasone (4mg/ml), diclofenac sodium (25mg/ml), 0.5% bupivacaine and 2% lidocaine given to the patients with symptomatic irreversible pulpitis after completion of the first appointment. Objectives: 1. To evaluate postoperative pain in patients receiving intraligamentary injections of either dexamethasone (4mg/ml), diclofenac sodium (25mg/ml), 0.5% bupivacaine or 2% lidocaine. 2. To compare the postoperative pain in different groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The patients will receive a primary Inferior alveolar nerve block injection using 1.8 mL of 2% lidocaine with 1: 80 000 epinephrine using a direct Halsted approach. The needle will be inserted until bony resistance is felt. After reaching the target area, aspiration will be performed, and the solution will be deposited over 60 seconds. After 10 minutes, the patients will be asked about the lip numbness. Patients without profound lip numbness will be excluded from the study since the block will be considered as 'missed'. A conventional access opening will be initiated after isolation with a rubber dam. After endodontic instrumentation and placement of temporary restoration, the patients shall receive intraligamentary injections of dexamethasone (4mg/ml), diclofenac sodium (25mg/ml), 0.5% bupivacaine, and 2% lidocaine. The patients will be randomly allocated to treatment groups with the help of an online random generator. The presence of postoperative pain (using Heft Parker visual analog pain scale) will be assessed at 2 hours, 6 hours, 24 hours, and 72 hours after treatment. The pain score proforma shall be collected at the subsequent visit.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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, opioids, antidepressants, anticonvulsants, muscle relaxants, anxiolytics, sedatives, NSAIDs.
  • Pregnant or breastfeeding patients.
  • Patients with asthma, gastric ulcers, and bleeding disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraligamentary injection of dexamethasone
After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone
Drug: Dexamethasone
After endodontic instrumentation and placement of temporary restoration, the patients shall receive intraligamentary injections.
Other Names:
  • bupivacaine
  • diclofenac sodium
Experimental: Intraligamentary injection of diclofenac sodium
After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone
Drug: Dexamethasone
After endodontic instrumentation and placement of temporary restoration, the patients shall receive intraligamentary injections.
Other Names:
  • bupivacaine
  • diclofenac sodium
Experimental: Intraligamentary injection of 0.5% bupivacaine
After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone
Drug: Dexamethasone
After endodontic instrumentation and placement of temporary restoration, the patients shall receive intraligamentary injections.
Other Names:
  • bupivacaine
  • diclofenac sodium
Active Comparator: Intraligamentary injection of 2% lidocaine
After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone
Drug: Dexamethasone
After endodontic instrumentation and placement of temporary restoration, the patients shall receive intraligamentary injections.
Other Names:
  • bupivacaine
  • diclofenac sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative pain
Time Frame: 2 hours, 6 hours, 24 hours and 72 hours after treatment
The presence of postoperative pain (using Heft Parker visual analog pain scale) will be assessed at 2 hours, 6 hours, 24 hours and 72 hours after treatment.
2 hours, 6 hours, 24 hours and 72 hours after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jamia Millia Islamia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2023

Primary Completion (Estimated)

March 3, 2024

Study Completion (Estimated)

March 3, 2024

Study Registration Dates

First Submitted

December 17, 2023

First Submitted That Met QC Criteria

December 17, 2023

First Posted (Estimated)

January 1, 2024

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 17, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Postendo pain Intraligamentary

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulpitis

Clinical Trials on Dexamethasone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe