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

NCT06500871 | Not Yet Recruiting Early Phase 1

• 1 other identifier: ENDO 9-1-2
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Teeth With Acute Irreverseble Pulpitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Intensity of intraoperative pain

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

• Post-operative pain

  6, 12, 24 and 48 hours post-operatively

• Number of needed analgesic tablets in case of intolerable pain

  Up to 2 days post operatively

Study Arms (2)

Diclofenac Potassium

EXPERIMENTAL

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

Drug: Diclofenac Potassium

Articaine Anaesthetic solution

ACTIVE COMPARATOR

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

Drug: Diclofenac Potassium

Interventions

Diclofenac Potassium DRUG

NSAID

Articaine Anaesthetic solution; Diclofenac Potassium

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Diclofenac

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Mai Eldeeb, master

CONTACT

01093738532; mai.eldeeb@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at faculty of dentistry

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: August 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08