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

NCT ID: NCT06457828

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2024-09-30

Brief Summary

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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

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Conditions

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Postoperative Pain Symptomatic Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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No apical patency

Group Type SHAM_COMPARATOR

Non-corticosteroid injection

Intervention Type PROCEDURE

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

Corticosteroid injection

Intervention Type DRUG

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

Apical patency

Group Type ACTIVE_COMPARATOR

Non-corticosteroid injection

Intervention Type PROCEDURE

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

Corticosteroid injection

Intervention Type DRUG

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

Interventions

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Non-corticosteroid injection

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

Intervention Type PROCEDURE

Corticosteroid injection

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Suez Canal University

OTHER

Sponsor Role lead

Responsible Party

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Mustafa M. Sultan

Teaching assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Suez Canal University

Ismailia, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mustafa Sultan

Role: CONTACT

+201111506890

Facility Contacts

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Mustafa Sultan

Role: primary

+201111506890

Other Identifiers

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291/2020

Identifier Type: -

Identifier Source: org_study_id

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