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).
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
- Conditions the study is for
- Endodontically Treated Teeth, Primary Teeth, Pulp Necroses
- 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
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.
- Conditions
- Endodontically Treated Teeth, Primary Teeth, Pulp Necroses
- 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 group | Role | What they receive |
|---|---|---|
| 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 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® EAL | Electronic 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 EAL | Electronic 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.
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.
- First posted20 Nov 2020
- Study start17 Oct 2020
- Primary completion4 Nov 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontically Treated TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seçil Çalışkan, Eskisehir Osmangazi University
- Investigators
- Seçil Çalışkan, Principal investigator, Eskişehir Osmangazi University
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An In-Vivo Evaluation of the Accuracy of Different Generation Apex Locators and Tactile Sense in Primary Teeth
- ClinicalTrials.gov ID
- NCT04638972
- Acronym / sponsor ID
- E25403353-050.99-107474
- Conditions
- Endodontically Treated Teeth, Primary Teeth, Pulp Necroses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 17 Oct 2020 (actual)
- Primary completion
- 4 Nov 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tactile Sense Method | – | Device: working length determination techniquesIn 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 |
| Radiographic Method (digital periapical radiography) | – | Device: working length determination techniquesIn 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 |
| Ipex® EAL | – | Device: working length determination techniquesElectronic apex locaters (EALs), which are based on electrical principles instead of visual determinants, have been used more frequently in primary teeth. |
| Propex® pixi EAL | – | Device: working length determination techniquesElectronic apex locaters (EALs), which are based on electrical principles instead of visual determinants, have been used more frequently in primary teeth. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Age groups
- 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
Key inclusion criteria (1 listed)
- Children without any systemic diseases
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| working length determination techniquesA 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. | Device | Ipex® EAL, Propex® pixi EAL, Radiographic Method (digital periapical radiography), Tactile Sense Method |
Primary outcome
Determination of root canal working length
Time frame: 1 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seçil Çalışkan principal investigator
Eskişehir Osmangazi University
1 site in 1 country: see every site and its status.
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.