Evaluation of the Effect of Intra-ligamentary Injection of Diclofenac Potassium Versus Articaine on Anaesthetic Efficacy in Mandibular Molars With Symptomatic Irreversible Pulpitis.

Evaluation of the Effect of Intra-ligamentary Injection of Diclofenac Potassium Versus Articaine on Anaesthetic Efficacy in Mandibular Molars With Symptomatic Irreversible Pulpitis:A Randomized Controlled Trial

This study aims to assess the effect the intraligamentary injection of Diclofenac Potassium versus Articaine 4% on the anaesthetic efficacy & intensity of intraoperative & postoperative pain during single visit root canal treatment in patients with symptomatic irreversible pulpitis in mandibular molar teeth

Study Overview

• Status: Not yet recruiting
• Conditions: Teeth With Acute Irreverseble Pulpitis
• Intervention / Treatment: Drug: Diclofenac Potassium

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Mai Eldeeb, master; Phone Number: 01093738532; Email: mai.eldeeb@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Systemically healthy patient (ASA I or II).
• Mandibular Posterior teeth with:

Preoperative sharp pain, Absence or slight widening in the periodontal ligament (PDL), Vital response of pulp tissue to cold pulp test.

• patients who agree to provide written consent and the patients able to understand the pain scale and attend for recall appointments

Exclusion Criteria:

1. Patients allergic to anesthetic solutions & other NSAIDs.
2. Pregnant or nursing females.
3. Patients having significant systemic disorder (ASA III or IV).
4. Gastrointestinal disorders.
5. If the initial diagnosis revealed pain in more than one tooth.
6. Hemostatic disorders or anti-coagulant therapy during the last month.
7. Consumption of opioid or non-opioid analgesics or NSAIDs during the last 12 hours before treatment.

8. Teeth that have:

   i. Periodontal involvement (with pocket depth greater than 5mm, associated with swelling or fistulous tract, or greater than grade I mobility).

   ii. No possible restorability. iii.Signs of pulpal necrosis; associated sinus tract or swelling.

   -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diclofenac Potassium; 0.4 ml diclofena potassium injection 75mg/3ml drug used as Supplemental intraligamentary injection	Drug: Diclofenac Potassium; NSAID
Active Comparator: Articaine Anaesthetic solution; Articaine 4% with (1:100,000 Epinephrine) local anesthetic solution will be used as intraligamentary injection,	Drug: Diclofenac Potassium; NSAID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of local anesthesia	using Heft parker Visual Analogue scale Binary where success is defined as no pain or faint/weak /mild pain<55 mm). if >55 defined as failure	intraoperative ( access cavity preparation & instrumentation ) during root canal treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of needed analgesic tablets in case of intolerable pain	by counting	Up to 2 days post operatively
Intensity of intraoperative pain	using Heft parker Visual analogue scale score ranges from on a 170-mm VAS line with the ends labeled "no pain" and "unbearable pain. .no pain (< 5 mm), mild pain (≥ 5 mm and ≤ 54 mm), Moderate pain (> 54 mm and < 114 mm), Severe pain (≥ 114 mm).	intraoperative ( access cavity preparation & instrumentation ) during root canal treatment
Post-operative pain	using Heft parker Visual analogue scale on a 170-mm VAS line with the ends labeled "no pain" and "unbearable pain. .no pain (< 5 mm), mild pain (≥ 5 mm and ≤ 54 mm), Moderate pain (> 54 mm and < 114 mm), Severe pain (≥ 114 mm).	6, 12, 24 and 48 hours post-operatively

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 3, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: ENDO 9-1-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No