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Endodontically Treated TeethNCT04638972

Accuracy of Apex Locators in Primary Teeth

An observational study of Endodontically Treated Teeth and Primary Teeth, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 8 years
What is being tested?
working length determination techniques
Type of treatment
Medical device
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
17 Oct 2020to 10 Nov 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 8 years
  • All sexes
  • Child

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

Who may be able to join

  • Children without any systemic diseases

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Eskişehir Osmangazi University

    Eskişehir, 26040

Other trials in Turkey (Türkiye)

About this study

Official title: An In-Vivo Evaluation of the Accuracy of Different Generation Apex Locators and Tactile Sense in Primary Teeth

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.

Read the detailed description

The teeth were first anaesthetized with Ultracaine Ds-Forte (Sanofi Aventis, İstanbul, Türkiye) and then isolated with rubber dam. Caries was removed and access cavity was prepared using a round diamond bur with copious water in each tooth. Barbed broaches were used to extirpate the pulpal tissue and 2.5 % sodium hypochlorite was used as the irrigation solution. Sterile cotton pellets were used to dry the cavity.

For working length determination, the groups were performed as; 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 (n=90).

Root canal length determination by tactile sense method:

In the determination of working length using tactile sense, a K-file with the tip that best adjusted to the apical area was selected and gently inserted into the canal until the operator felt the narrowest region. The silicone stop was then placed at the coronal reference, and tooth length considering the end of the root was measured with an endodontic ruler (0.5mm accuracy).

Root canal length determination by radiographic method:

In group 2, working length determination was performed with digital periapical radiograph (……………….). Before the radiographic evaluation, the protective thyroid lead and protective lead apron were used for all children. Digital periapical radiograph was taken with using paralleling technique while the files were in the canals. X-ray positioning device (FPS 3000-Film positioning system complete, TPC Advanced Technology Inc., California, USA) was used to standardize the distances between the source and the tooth, and the tooth and the film. Cusp adjacent to the canal was taken as the occlusal reference. Files, 1 mm shorter than the tooth length as recorded according to the preoperative radiograph, were inserted in the canals. The difference between the tip of the file and the end of the root was calculated on the image. In case the file had not passed the apex, this amount and the original length was calculated. In case the file had passed the apex, the amount was subtracted from the original length. Lastly, 1 mm was subtracted from this adjusted length to confirm the cemento-dentinal junction and recorded as radiographic working length.

Root canal length determination by EALs:

The electronic working length determination was performed either with Ipex®/Goup 2 (NSK Ltd, Tokyo, Japan) or ProPex Pixi®/Group 3 (Dentsply Maillefer, Ballaigues, Switzerland) apex locators. Lip clip was attached to patients' lower lip in order to complete the circuit. Then, the root canals were moistened with 0.9% saline solution, and a no.15 K- file (Dentsply Maillefer, Baillaigues, Switzerland) mounted to the holder was gently inserted till "0.5" signaled on the screen, meaning that the tip of file was at the apical constriction. If the reading was stable for at least 5 seconds, the file was pulled back and the length between the silicone stopper and the tip of the file was measured with an endodontic ruler.

Endodontic treatment was completed in same appointments.

Being tested
working length determination techniques
Medical subject headings
Tooth, Nonvital, Dental Pulp Necrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • working length determination techniquesDevice

    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.

Study groups in NCT04638972
Study groupRoleWhat they receive
Tactile Sense MethodIn 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
Receives: 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
Receives: Device: working length determination techniques
Ipex® EALElectronic apex locaters (EALs), which are based on electrical principles instead of visual determinants, have been used more frequently in primary teeth.
Receives: Device: working length determination techniques
Propex® pixi EALElectronic apex locaters (EALs), which are based on electrical principles instead of visual determinants, have been used more frequently in primary teeth.
Receives: Device: working length determination techniques

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2020
  2. Study start17 Oct 2020
  3. Primary completion4 Nov 2020
  4. Study completion10 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04638972
Sponsor's protocol ID
E25403353-050.99-107474
Status last verified
Nov 2020
First submitted
12 Nov 2020
Last updated
20 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Endodontically Treated Teeth and Primary Teeth, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of root canal working length (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.

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