NCT05726357

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
380

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

February 1, 2023

Last Update Submit

August 2, 2023

Conditions

Pulpitis - Irreversible

Keywords

vital pulp therapy

Outcome Measures

Primary Outcomes (1)

  • pain score

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

    day 3 post treatment

Secondary Outcomes (1)

  • pain score

    6 months post treatment

Study Arms (2)

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

vital pulp therapyPROCEDURE

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

Pulpotomystandard root canal treatment

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, 11837, Egypt

RECRUITING

Study Officials

  • shehabeldin Saber

    Professor of Endodontics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shehabeldin Saber, phD

CONTACT

+202 26890000shehabeldin.saber@bue.edu.eg

Dalia Ghalwash, phD

CONTACT

+202 26890000dalia.ghalwash@bue.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 13, 2023

Study Start

April 1, 2023

Primary Completion

March 31, 2024

Study Completion

November 30, 2024

Last Updated

August 3, 2023

Record last verified: 2023-08

Locations

EG(1)