Effect of Intrapulpal Injections on the Post-endodontic Pain

NCT ID: NCT06088446

Last Updated: 2023-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2023-10-03

Brief Summary

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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.

Detailed Description

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Conditions

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Pulpitis - Irreversible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Supplementary Intrapulpal injection

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

Group Type ACTIVE_COMPARATOR

Supplementary anesthetic injections

Intervention Type PROCEDURE

Supplementary anesthetic injections after failed primary nerve block

Intraligamentary injection

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

Group Type ACTIVE_COMPARATOR

Supplementary anesthetic injections

Intervention Type PROCEDURE

Supplementary anesthetic injections after failed primary nerve block

Interventions

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Supplementary anesthetic injections

Supplementary anesthetic injections after failed primary nerve block

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jamia Millia Islamia

OTHER

Sponsor Role lead

Responsible Party

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Dr. Vivek Aggarwal

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Jamia MIliia Islamia

New Delhi, , India

Site Status

Countries

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India

Other Identifiers

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Intrapulpal

Identifier Type: -

Identifier Source: org_study_id

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