NCT04638972

Brief Summary

The aim of this study was to evaluate the effectiveness of tactile sense, digital periapical radiograph and two different varieties of electronic apex locators at working length determination in primary molars. A total of 30 infected mandibular primary second molar teeth in twelve children aged between 5 and 8 years were included in this study. Working length determination was performed using tactile sense, radiographic method and two different varieties of electronic apex locators (ProPex Pixi® and Ipex®) separately.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 17, 2020

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2020

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

18 days

First QC Date

November 12, 2020

Last Update Submit

November 19, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Determination of root canal working length

    Data were collected from measurements taken from each primary molar's root canal working length. Group 1: Tactile Sense Method Group 2: Radiographic Method (digital periapical radiography) Group 3: Ipex® EAL Group 4: Propex® pixi EAL The measurement techniques given in the groups were used in each root canal of all primary molars. After collection of the data, measurements taken from each root canal measurement method were compared.

    1 month

Study Arms (4)

Tactile Sense Method

In clinical practice, tactile sense and conventional radiography have been the methods of choice for determination of working length for a long time. However, these two methods have some limitations in determining working length. While the accuracy rate in tactile sense changes with experience, radiographic examination in children is usually hard due to poor cooperation or the unsuitable sensor size for child's small mouth \[7\]. Also, these techniques may yield inaccurate information especially in cases with root resorption

Device: working length determination techniques

Radiographic Method (digital periapical radiography)

In clinical practice, tactile sense and conventional radiography have been the methods of choice for determination of working length for a long time. However, these two methods have some limitations in determining working length. While the accuracy rate in tactile sense changes with experience, radiographic examination in children is usually hard due to poor cooperation or the unsuitable sensor size for child's small mouth \[7\]. Also, these techniques may yield inaccurate information especially in cases with root resorption

Device: working length determination techniques

Ipex® EAL

Electronic apex locaters (EALs), which are based on electrical principles instead of visual determinants, have been used more frequently in primary teeth.

Device: working length determination techniques

Propex® pixi EAL

Electronic apex locaters (EALs), which are based on electrical principles instead of visual determinants, have been used more frequently in primary teeth.

Device: working length determination techniques

Interventions

A total of 30 infected mandibular primary second molar teeth in twelve children aged between 5 and 8 years were included in this study. Working length determination was performed using tactile sense, radiographic method and two different varieties of electronic apex locators (ProPex Pixi® and Ipex®) separately.

Ipex® EALPropex® pixi EALRadiographic Method (digital periapical radiography)Tactile Sense Method

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

A total of 30 infected mandibular primary second molar teeth (90 canals) of twelve children aged between 5 and 8 years were included in this in vivo study

You may qualify if:

  • \- Children without any systemic diseases

You may not qualify if:

  • Children with any systemic diseases as a contraindication to endodontic treatment (such as cardiac diseases, epilepsy etc.)
  • Teeth with previous root canal manipulation, radiographic evidence of calcification, perforated pulpal floor, excessive internal root resorption, external resorption more than two-thirds of the root, excessive bone loss in the furcation and insufficient structure for restoration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskişehir Osmangazi University

Eskişehir, 26040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tooth, NonvitalDental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Seçil Çalışkan

    Eskişehir Osmangazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 20, 2020

Study Start

October 17, 2020

Primary Completion

November 4, 2020

Study Completion

November 10, 2020

Last Updated

November 20, 2020

Record last verified: 2020-11

Locations