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Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis

Primary Purpose

Pulpitis - Irreversible

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

vital pulp therapy

About this trial

This is an interventional treatment trial for Pulpitis - Irreversible focused on measuring vital pulp therapy

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Faculty of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

standard root canal treatment

Pulpotomy

Arm Description

standard root canal treatment

vital pulp therapy

Outcomes

Primary Outcome Measures

pain score

score by a numeric rating scale from 1(minimum pain) to 100 (maximum pain)

Secondary Outcome Measures

pain score

score by a numeric rating scale from 1(minimum pain) to 100 (maximum pain)

Full Information

NCT ID

NCT05726357

First Posted

February 1, 2023

Last Updated

August 2, 2023

Sponsor

British University In Egypt

1. Study Identification

Unique Protocol Identification Number

NCT05726357

Brief Title

Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis

Official Title

Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis: A Randomised Control Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2023 (Actual)

Primary Completion Date

March 31, 2024 (Anticipated)

Study Completion Date

November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

British University In Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulpitis - Irreversible

Keywords

vital pulp therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

standard root canal treatment

Arm Type

Active Comparator

Arm Description

standard root canal treatment

Arm Title

Pulpotomy

Arm Type

Active Comparator

Arm Description

vital pulp therapy

Intervention Type

Procedure

Intervention Name(s)

vital pulp therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

pain score

Description

score by a numeric rating scale from 1(minimum pain) to 100 (maximum pain)

Time Frame

day 3 post treatment

Secondary Outcome Measure Information:

Title

pain score

Description

score by a numeric rating scale from 1(minimum pain) to 100 (maximum pain)

Time Frame

6 months post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shehabeldin Saber, phD

Phone

+202 26890000

Ext

1065

shehabeldin.saber@bue.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Dalia Ghalwash, phD

Phone

+202 26890000

Ext

1066

dalia.ghalwash@bue.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

shehabeldin Saber

Organizational Affiliation

Professor of Endodontics

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Dentistry

City

Cairo

ZIP/Postal Code

11837

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

shehabeldin mohamed saber, phd

Phone

+201001413734

shehabeldin.saber@bue.edu.eg

First Name & Middle Initial & Last Name & Degree

dalia ghalwash, phd

Phone

+201005120159

dalia.ghalwash@bue.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

not to be shared

Learn more about this trial

Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis

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