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Clinical trial

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

ID
Name
Postendo pain Intraligamentary
Description
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.
Trial arms
Trial start
2023-12-02
Estimated PCD
2024-03-03
Trial end
2024-03-03
Status
Recruiting
Treatment
Dexamethasone
After endodontic instrumentation and placement of temporary restoration, the patients shall receive intraligamentary injections.
Arms:
Intraligamentary injection of 0.5% bupivacaine, Intraligamentary injection of 2% lidocaine, Intraligamentary injection of dexamethasone, Intraligamentary injection of diclofenac sodium
Other names:
diclofenac sodium, bupivacaine
Size
140
Primary endpoint
Post operative pain
2 hours, 6 hours, 24 hours and 72 hours after treatment
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 140, 'type': 'ESTIMATED'}}
Updated at
2024-01-02

1 organization

1 product

1 indication

Organization
Jamia Millia Islamia
Product
Dexamethasone
Indication
pulpitis