Pulpotomy vs Root Canal Treatment for Teeth With Symptoma... | NCT05726357

Studies
Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis

NCT05726357

Sponsor

British University In Egypt

Status

Unknown status

Last Update Posted

Aug 3, 2023Actual

Enrollment

380Estimated

Phase

Not Applicable

Conditions

Pulpitis - Irreversible

Interventions

vital pulp therapy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2023Actual

Primary Completion Date

Mar 31, 2024Estimated

Completion Date

Nov 30, 2024Estimated

First Submitted Date

Feb 1, 2023

First Submission Date that Met QC Criteria

Feb 11, 2023

First Posted Date

Feb 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2023

Last Update Posted Date

Aug 3, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

380Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
standard root canal treatment	Active Comparator	standard root canal treatment	Procedure: vital pulp therapy
Pulpotomy	Active Comparator	vital pulp therapy	Procedure: vital pulp therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vital pulp therapy	Procedure	removal of the coronal pulp followed by placing a biocompatible material to preserve the vitality of the radicular pulp	Pulpotomy standard root canal treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain score	score by a numeric rating scale from 1(minimum pain) to 100 (maximum pain)	day 3 post treatment

Secondary Outcomes

Measure	Description	Time Frame
pain score	score by a numeric rating scale from 1(minimum pain) to 100 (maximum pain)	6 months post treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shehabeldin Saber, phD	Contact	+202 26890000	1065	shehabeldin.saber@bue.edu.eg
Dalia Ghalwash, phD	Contact	+202 26890000	1066	dalia.ghalwash@bue.edu.eg

Overall Officials

Name	Affiliation	Role
shehabeldin Saber	Professor of Endodontics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dentistry	Recruiting	Cairo		11837	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

not to be shared

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided