NCT05279820

Brief Summary

This study aims at comparing the outcome of partial pulpotomy and full pulpotomy in the management of carious pulp exposures in permanent teeth with a clinical diagnosis of irreversible pulpits. The primary outcome is resolution of symptoms and the secondary outcome is clinical and radiographic normality at 1 and 2 years follow up. The study design will be a double blind randomized clinical trial.

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
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

November 28, 2021

Last Update Submit

March 14, 2022

Conditions

Carious Exposure of PulpIrreversible PulpitisPulpotomy

Keywords

irreversible pulpitsPulpotomyOutcome

Outcome Measures

Primary Outcomes (2)

  • Post operative pain level measured by visual analogy scale from 0-10

    scale from 0-10

    48 hours

  • Post operative pain level measured by a numerical scale from 0-10

    scale from 0-10

    48 hours

Secondary Outcomes (2)

  • Clinical success as measured by clinical examination

    6, 12, 24 months

  • Radiographic success as evaluated by periapical x-rays

    6, 12, 24 months

Study Arms (2)

Partial Pulpotomy

ACTIVE COMPARATOR

After pulp exposure 2-3 mm of the pulp tissue will be amputated, a calcium silicate based material will be placed over the pulp and the tooth will be restored.

Procedure: Partial pulpotomy

Full Pulpotomy

ACTIVE COMPARATOR

After pulp exposure the entire coronal pulp to the level of canal orifices will be amputated , calcium silicate based material will be placed over the pulp and the tooth will be restored.

Procedure: Full Pulpotomy

Interventions

Partial pulpotomyPROCEDURE

Partial pulp tissue amputation

Partial Pulpotomy
Full PulpotomyPROCEDURE

Full Pulpotomy

Full Pulpotomy

Eligibility Criteria

Age10 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mature permanent tooth
  • Deep caries extending more than two thirds of dentine or exposing the pulp
  • Tooth responds positively to cold test
  • Clinical symptoms of irreversible pulpits
  • Tooth is restorable and can be restored with coronal restoration
  • Bleeding normally is confirmed after pulp exposure
  • hemostasis could be achieved within 8 minutes

You may not qualify if:

  • Non restorable teeth
  • necrotic teeth
  • hemostasis could not be achieved within 8 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University of science and technology

Irbid, 22110, Jordan

RECRUITING

Related Publications (1)

  • Taha NA, About I, Sedgley CM, Messer HH. Conservative Management of Mature Permanent Teeth with Carious Pulp Exposure. J Endod. 2020 Sep;46(9S):S33-S41. doi: 10.1016/j.joen.2020.06.025.

    PMID: 32950193BACKGROUND

Study Officials

  • Nessrin Taha, PhD

    Jordan University of Science and Technology

    STUDY CHAIR

Central Study Contacts

Nessrin Taha, PhD

CONTACT

+962776566110n.taha@just.edu.jo

Nessrin Taha, PhD

CONTACT

nessrin_taha@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The participant will not be informed whether the treatment performed was partial or full pulpotomy the outcome assessor will be blinded to the type of treatment performed, and evaluation of the radiographs will include masking the crown so that the procedure cannot be identified.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study will run concurrently and the participants will randomly distributed between the two interventions using a block randomization procedure
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2021

First Posted

March 15, 2022

Study Start

June 1, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2024

Last Updated

March 15, 2022

Record last verified: 2022-03

Locations

JO(1)