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

NCT06457828 | Recruiting

• 1 other identifier: 291/2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Symptomatic Irreversible Pulpitis

Keywords

Pulpitis; Postoperative Pain; VAS

Outcome Measures

Primary Outcomes (2)

• Post-operative pain

  Patients were instructed to record their pain level using the Visual Analog Scale

  6, 12, 24, 48, 72 hour and 7 days postoperative intervals

• Inflammatory markers

  Gingival crevicular fluid samples were collected by periopaper for testing the level of IL-1β and IL-10

  before treatment, after 3 days and after 7 days

Study Arms (2)

No apical patency

SHAM COMPARATOR

Procedure: Non-corticosteroid injection; Drug: Corticosteroid injection

Apical patency

ACTIVE COMPARATOR

Procedure: Non-corticosteroid injection; Drug: Corticosteroid injection

Interventions

Non-corticosteroid injection PROCEDURE

no infiltration injection of 0.7 ml of dexamethasone lateral to the involved tooth after anesthesia administration.

Apical patency; No apical patency

Corticosteroid injection DRUG

infiltration injection of 0.7 ml of dexamethasone lateral to the involved tooth after anesthesia administration.

Apical patency; No apical patency

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Pulpitis

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Mustafa Sultan

CONTACT

+201111506890; sultan_mustafa@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant

Study Record Dates

• First Submitted: June 8, 2024
• First Posted: June 13, 2024
• Study Start: February 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

EG (1)