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Diclofenac Potassium vs Articaine for Pain Management in Mandibular Molars with Irreversible Pulpitis

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Study Aim

This study aims to compare the effectiveness of Diclofenac Potassium and Articaine in managing pain for adults with irreversible pulpitis in their lower back teeth.

What is being tested

Diclofenac Potassium

Drug
Who is being recruted

From 18 to 55 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Early Phase 1
Interventional
Study Start: August 2024
See protocol details

Summary

Principal SponsorCairo University
Study ContactMai Eldeeb, master
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2024

Actual date on which the first participant was enrolled.

This study is examining how two different medications, Diclofenac Potassium and Articaine 4%, work when injected directly into the ligament around a tooth to provide pain relief. The focus is on patients who have symptomatic irreversible pulpitis, a painful condition affecting the nerves inside molar teeth, specifically in the lower jaw. This research is important because it aims to find out which medication offers better pain relief during and after a root canal treatment, potentially improving comfort and outcomes for patients with this dental issue. Participants in the study receive an injection of either Diclofenac Potassium or Articaine into the area around their affected tooth. The study then measures how well each medication works to numb the area and reduce pain, both during the root canal procedure and afterwards. By comparing the effectiveness of these two treatments, the study seeks to identify which option provides better anesthetic results and pain management for people undergoing dental procedures for symptomatic irreversible pulpitis.

Official TitleEvaluation 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
NCT06500871
Principal SponsorCairo University
Study ContactMai Eldeeb, master
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Articaine 4% with (1:100,000 Epinephrine) local anesthetic solution will be used as intraligamentary injection,

Group II

Experimental
0.4 ml diclofena potassium injection 75mg/3ml drug used as Supplemental intraligamentary injection

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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