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

NCT ID: NCT06500871

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2025-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Diclofenac Potassium

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

Group Type: EXPERIMENTAL

Diclofenac Potassium

Intervention Type: DRUG

NSAID

Articaine Anaesthetic solution

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

Group Type: ACTIVE_COMPARATOR

Diclofenac Potassium

Intervention Type: DRUG

NSAID

Interventions

Diclofenac Potassium

NSAID

Intervention Type: DRUG

Eligibility 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.

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mai Abdou Ibraheem

Resident at faculty of dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mai Eldeeb, master

Role: CONTACT

mai.eldeeb@dentistry.cu.edu.eg

01093738532

Other Identifiers

ENDO 9-1-2

Identifier Type: -

Identifier Source: org_study_id