Effect of Intrapulpal Injections on the Post-endodontic Pain

Pulpitis - Irreversible Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06088446
• Other study ID #: Intrapulpal
• Status: Completed
• Phase: N/A
• Start date: July 5, 2023
• Est. completion date: October 3, 2023

Study information

• Verified date: October 2023
• Source: Jamia Millia Islamia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: October 3, 2023
• Est. primary completion date: October 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulpitis
• Pulpitis - Irreversible

Intervention

Procedure:
• Supplementary anesthetic injections
Supplementary anesthetic injections after failed primary nerve block

Locations

Country	Name	City	State
India	Faculty of Dentistry, Jamia MIliia Islamia	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Jamia Millia Islamia

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6hours, 1 day, 3 days, 7 days