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NCT Number: NCT06500871

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

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

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Key information

Conditions

Teeth With Acute Irreverseble Pulpitis

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Diclofenac Potassium

Drug

NSAID

Primary outcomes

Efficacy of local anesthesia

Time frame: intraoperative ( access cavity preparation & instrumentation ) during root canal treatment

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

Secondary outcomes

Intensity of intraoperative pain

Time frame: intraoperative ( access cavity preparation & instrumentation ) during root canal treatment

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).
Post-operative pain

Time frame: 6, 12, 24 and 48 hours post-operatively

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).
Number of needed analgesic tablets in case of intolerable pain

Time frame: Up to 2 days post operatively

by counting

Study contacts

Contact information is provided by the study sponsor or research team.

Mai Eldeeb, master

CONTACT

[email protected]

01093738532

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jul 15, 2024
Registry last updated: Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.