NCT04262362

Brief Summary

Sodium hypochlorite is a commonly used irrigation agent. However, the solution may extrude beyond the apex of tooth and cause pain during the treatment.The aim of this prospective observational investigation is to determinate the frequency of the extrusion of sodtium hypochlorite in endodontically treated teeth.

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

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

December 5, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2020

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

February 6, 2020

Last Update Submit

February 7, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of pain and symptoms

    pain or other symptoms due to sodium hypochlorite extrusion

    During treatment

Interventions

Incidence of pain that may occur due to sodium hypochlorite extrusion

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patient refer for routine endodontic treatment will be included.

You may qualify if:

  • Requirement of root canal treatment

You may not qualify if:

  • Sodium hypochlorite allergy
  • Immature tooth
  • root resorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bülent Ecevit University, Faculty of Dentistry

Zonguldak, 67600, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Acute PainDental Pulp Necrosis

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic Processes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 10, 2020

Study Start

December 5, 2019

Primary Completion

September 14, 2020

Study Completion

September 14, 2020

Last Updated

February 10, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations