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Effect of Intrapulpal Injections on the Post-endodontic Pain

Primary Purpose

Pulpitis - Irreversible

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Supplementary anesthetic injections
Sponsored by
Jamia Millia Islamia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis - Irreversible

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Dentistry, Jamia MIliia Islamia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Supplementary Intrapulpal injection

Intraligamentary injection

Arm Description

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

Intraligamentary injections were given using an intraligamentary syringe with back-pressure after a failed primary inferior alveolar nerve block.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 3, 2023
Last Updated
October 17, 2023
Sponsor
Jamia Millia Islamia
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1. Study Identification

Unique Protocol Identification Number
NCT06088446
Brief Title
Effect of Intrapulpal Injections on the Post-endodontic Pain
Official Title
Effect of Intrapulpal Injections on the Post-endodontic Pain in Patients With Symptomatic Irreversible Pulpitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 5, 2023 (Actual)
Primary Completion Date
October 3, 2023 (Actual)
Study Completion Date
October 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jamia Millia Islamia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis - Irreversible

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supplementary Intrapulpal injection
Arm Type
Active Comparator
Arm Description
Supplementary Intrapulpal injections were given using a 30-gauze needle with sufficient back pressure.
Arm Title
Intraligamentary injection
Arm Type
Active Comparator
Arm Description
Intraligamentary injections were given using an intraligamentary syringe with back-pressure after a failed primary inferior alveolar nerve block.
Intervention Type
Procedure
Intervention Name(s)
Supplementary anesthetic injections
Intervention Description
Supplementary anesthetic injections after failed primary nerve block
Primary Outcome Measure Information:
Title
Post-endodontic pain using a visual analouge scale (VAS)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Dentistry, Jamia MIliia Islamia
City
New Delhi
ZIP/Postal Code
110025
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Intrapulpal Injections on the Post-endodontic Pain

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