NCT05279781

Brief Summary

Root canal therapy (RCT) is indicated once the pulp is diagnosed with irreversible pulpitis. Despite favorable success rate reported for RCT in vital cases, it is time consuming, and might increases fracture susceptibility of teeth. With the advancement of materials and better understanding of pulpal healing, vital pulp therapy is practiced as an alternative treatment with high success rate. The aim of this study is to explore the outcome, quality of life and patient satisfaction after full pulpotomy compared to RCT.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

5.5 years

First QC Date

November 23, 2021

Last Update Submit

October 24, 2022

Conditions

CariesPulpitis - Irreversible

Outcome Measures

Primary Outcomes (2)

  • Post operative pain level on numerical pain scale

    Pain level after treatment will be assessed on a numerical scale from 0-10 where is zero refer to no pain and 10 is the most sever pain.

    7 days

  • Post operative pain level on visual analogue scale

    Pain level after treatment will be assessed on a visual analogy scale from 0-10, where is zero refer to no pain and 10 is the most sever pain.

    7 days

Secondary Outcomes (2)

  • Clinical success

    6, 12, 24, 48 months

  • Radiographic success

    6, 12, 24, 48 months

Other Outcomes (1)

  • The quality of life questionnaire

    6,12, 24, 48 months

Study Arms (2)

Root canal treatment group

ACTIVE COMPARATOR

This group will receive complete root canal therapy

Procedure: Non surgical root canal treatment

Pulpotomy group

ACTIVE COMPARATOR

This group will receive full pulpotomy

Procedure: Pulpotomy

Interventions

Non surgical root canal treatmentPROCEDURE

Complete root canal treatment will be performed followed by direct restoration

Root canal treatment group
PulpotomyPROCEDURE

Full pulpotomy followed by direct restoration

Pulpotomy group

Eligibility Criteria

Age9 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Medically fit patient
  • mature permanent tooth with deep caries
  • diagnosis of irreversible pulpits.
  • tooth is restored with a direct restoration

You may not qualify if:

  • immature teeth
  • teeth were hemostasis cannot be achieved after pulpotomy
  • necrotic teeth
  • lack of response to cold test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University of science and technology

Irbid, 21110, 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: 32950193RESULT

MeSH Terms

Interventions

Pulpotomy

Intervention Hierarchy (Ancestors)

EndodonticsDentistry

Study Officials

  • Nessrin Taha, PhD

    Jordan University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof Taha

CONTACT

+962776566110n.taha@just.edu.jo

Nessrin Taha, PhD

CONTACT

+962776566110nessrin_taha@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant will not be informed whether complete pulp removal or partial treatment was done. Operator and investigator cannot be blinded due to differences in the procedure and it will be evident on the radiographs, so it cannot be masked during radiographic evaluation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups. One will receive root canal treatment t and the other will receive pulpotomy.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2021

First Posted

March 15, 2022

Study Start

April 1, 2019

Primary Completion

September 20, 2024

Study Completion

January 1, 2025

Last Updated

October 26, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

After collection of data and publication , data might be made available for the benefit off other researchers

Locations

JO(1)