Effect of Apical Patency and Local Corticosteroid on Pain and Neuropeptides Release in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

Not Applicable

Recruiting

• Conditions: Postoperative Pain; Symptomatic Irreversible Pulpitis
• Interventions: Procedure: Non-corticosteroid injection; Drug: Corticosteroid injection

• Registration Number: NCT06457828
• Lead Sponsor: Suez Canal University

Brief Summary

The goal of this randomized clinical trial is to learn the effect of using local corticosteroids and maintaining apical patency in reducing post-preparation pain in patients with acute irreversible pulpitis in molar teeth. The main question it aims to answer is:

• How effective are using local corticosteroids and maintaining apical patency in reducing post-preparation pain in patients with acute irreversible pulpitis? Participants will be asked to fill a visual analogue scale to record their pain, after receiving a root canal treatment while using local corticosteroids or not as well as maintaining apical patency or not.

Researchers will compare the use of corticosteroids and maintaining apical patency in reducing post-operative pain.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Status Verified: 2024-06
• Primary Completion: 2024-06
• Study First Submitted: 2024-06-08
• Study First Submitted QC: 2024-06-08
• Last Update Submitted: 2024-06-08
• Study First Posted: 2024-06-13
• Last Update Posted: 2024-06-13
• Study Completion: 2024-09

Recruitment & Eligibility

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

Inclusion Criteria

• Symptomatic acute irreversible pulpitis in molar teeth.
• Normal periapical condition including periapical radiography with minimal widening of periodontal ligament.
• Normal probing depth.
• No medical condition.
• No contraindication for administration of corticosteroids and local anesthesia.

Exclusion Criteria

• Facial or oral paresthesia.
• Pregnancy & breastfeeding.
• Unrestorable tooth.
• Marginal periodontal disease.
• Presence of a crown on the tooth involved.
• Over instrumentation during root canal treatment.
• Long-term use of corticosteroids.
• False-positive cases of sensibility test with necrosis discovered after gaining access to the tooth.
• Cases requiring intrapulpal injection to promote anesthesia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
No apical patency	Corticosteroid injection	-
No apical patency	Non-corticosteroid injection	-
Apical patency	Non-corticosteroid injection	-
Apical patency	Corticosteroid injection	-

Primary Outcome Measures

Name	Time	Method
Inflammatory markers	before treatment, after 3 days and after 7 days	Gingival crevicular fluid samples were collected by periopaper for testing the level of IL-1β and IL-10
Post-operative pain	6, 12, 24, 48, 72 hour and 7 days postoperative intervals	Patients were instructed to record their pain level using the Visual Analog Scale

Trial Locations

Locations (1)

Suez Canal University; 🇪🇬 Ismailia, Egypt