Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis

NCT ID: NCT05726357

Last Updated: 2023-08-03

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-11-30

Brief Summary

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high-quality evidence is needed to add to current knowledge and also assess the long-term outcomes for full/complete pulpotomy after carious pulpal exposure in patients with signs and symptoms indicative of irreversible pulpitis

Detailed Description

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Conditions

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Pulpitis - Irreversible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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standard root canal treatment

standard root canal treatment

Group Type ACTIVE_COMPARATOR

vital pulp therapy

Intervention Type PROCEDURE

removal of the coronal pulp followed by placing a biocompatible material to preserve the vitality of the radicular pulp

Pulpotomy

vital pulp therapy

Group Type ACTIVE_COMPARATOR

vital pulp therapy

Intervention Type PROCEDURE

removal of the coronal pulp followed by placing a biocompatible material to preserve the vitality of the radicular pulp

Interventions

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vital pulp therapy

removal of the coronal pulp followed by placing a biocompatible material to preserve the vitality of the radicular pulp

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* a mature permanent tooth
* symptoms indicative of IRP
* responsive to cold and EPT sensibility testing
* restorable and can be adequately isolated during treatment
* One tooth (molar or premolar) per patient.

Exclusion Criteria

* active periodontal disease
* complex medical histories
* unable to consent
* pregnant or breast-feeding
* excessive bleeding that cannot be controlled
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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British University In Egypt

OTHER

Sponsor Role lead

Responsible Party

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shehabeldin saber

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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shehabeldin Saber

Role: PRINCIPAL_INVESTIGATOR

Professor of Endodontics

Locations

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Faculty of Dentistry

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Shehabeldin Saber, phD

Role: CONTACT

+202 26890000 ext. 1065

Dalia Ghalwash, phD

Role: CONTACT

+202 26890000 ext. 1066

Facility Contacts

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shehabeldin mohamed saber, phd

Role: primary

+201001413734

dalia ghalwash, phd

Role: backup

+201005120159

Other Identifiers

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FD BUE REC 22-034

Identifier Type: -

Identifier Source: org_study_id

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