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

Early Phase 1

Not yet recruiting

• Conditions: Teeth With Acute Irreverseble Pulpitis
• Interventions: Drug: Diclofenac Potassium

• Registration Number: NCT06500871
• Lead Sponsor: Cairo University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-15
• Status Verified: 2024-08
• Study Start: 2024-08
• Last Update Submitted: 2024-08-03
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-05
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diclofenac Potassium	Diclofenac Potassium	0.4 ml diclofena potassium injection 75mg/3ml drug used as Supplemental intraligamentary injection
Articaine Anaesthetic solution	Diclofenac Potassium	Articaine 4% with (1:100,000 Epinephrine) local anesthetic solution will be used as intraligamentary injection,

Primary Outcome Measures

Name	Time	Method
Efficacy of local anesthesia	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 Outcome Measures

Name	Time	Method
Post-operative pain	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	Up to 2 days post operatively	by counting
Intensity of intraoperative pain	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).