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

Cairo University (CU)

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Teeth With Acute Irreverseble Pulpitis

Treatments: Drug: Diclofenac Potassium

Study type: Interventional

Funder types: Other

Identifiers

NCT06500871

ENDO 9-1-2

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Diclofenac Potassium

Experimental group

Description:

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

Treatment:

Drug: Diclofenac Potassium

Articaine Anaesthetic solution

Active Comparator group

Description:

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

Treatment:

Drug: Diclofenac Potassium