Intraligamentary Injections and Post-endodontic Pain

NCT ID: NCT06186921

Last Updated: 2024-01-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-02
• Study Completion Date: 2024-03-03

Brief Summary

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.

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.

Conditions

Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intraligamentary injection of dexamethasone

After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

After endodontic instrumentation and placement of temporary restoration, the patients shall receive intraligamentary injections.

Intraligamentary injection of diclofenac sodium

After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

After endodontic instrumentation and placement of temporary restoration, the patients shall receive intraligamentary injections.

Intraligamentary injection of 0.5% bupivacaine

After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

After endodontic instrumentation and placement of temporary restoration, the patients shall receive intraligamentary injections.

Intraligamentary injection of 2% lidocaine

After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

After endodontic instrumentation and placement of temporary restoration, the patients shall receive intraligamentary injections.

Interventions

Dexamethasone

After endodontic instrumentation and placement of temporary restoration, the patients shall receive intraligamentary injections.

Intervention Type: DRUG

Other Intervention Names

diclofenac sodium; bupivacaine

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, opioids, antidepressants, anticonvulsants, muscle relaxants, anxiolytics, sedatives, NSAIDs.
• 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

Jamia Millia Islamia

OTHER

Sponsor Role: lead

Responsible Party

Dr. Vivek Aggarwal

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry, Jamia MIliia Islamia

New Delhi, , India

Site Status: RECRUITING

Countries

India

Facility Contacts

Vivek Aggarwal, MDS

Role: primary

drvivekaggarwal@gmail.com

01126981818

Other Identifiers

Postendo pain Intraligamentary

Identifier Type: -

Identifier Source: org_study_id