Root Canal InfectionNCT06035185
Microbial Load After Apical Enlargement in Asymptomatic Teeth With Periapical Lesion
An observational study of Root Canal Infection and Periapical Diseases, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to define the role of apical shaping and irrigation activation on root canal cleanliness. The main questions it aims to answer are: does the effectiveness of irrigation activation depends on apical shaping? can a similar success be achieved by increasing apical shaping without… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal Infection, Periapical Diseases, Periapical; Infection
- What is being tested?
- apical shaping size
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Feb 2024to 27 Nov 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 24 patients who was referred to the Istanbul Medipol University Faculty of Dentistry Endodontic Clinic with the need for root canal treatment, with asymptomatic chronic apical periodontitis, witj clinical and radiographic findings. The study will be carried out in Istanbul Medipol University Faculty of Dentistry Endodontic Clinic, and patients with appropriate criteria will be informed about the treatment to be performed and their consent will be obtained. In this observational type study, patients treated by the same physician will be followed.
Who may be able to join
- Patients between the ages of 18-65
- Patients complying with the ASA1 and ASA2 classification (American Society of Anesthesiology)
- Patients who has molar teeth with radiolucent lesions in the periapical region
- The volunteer himself/herself or his/her legal representative wants to participate in the research by signing the 'Voluntary Consent Form'.
- Being able to tolerate the treatment physically and mentally
Who cannot join
- Patients who have taken antibiotics/corticosteroids in the last 3 months
- Patients with systemic disease
- Teeth that cannot be properly isolated with a rubber dam
- Teeth without coronal sealing,
- Teeth with periodontal pocket depth>4 mm and teeth with crown / root fracture.
- Individuals who continue or are considering starting orthodontic treatment during the research
Show all 9Show fewer
- Pregnant and lactating individuals
- The volunteer himself/herself or his/her legal representative does not want to participate in the research by signing the 'Voluntary Consent Form'.
- Teeth that are damaged enough to require post-core treatment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University School of Dentistry
Istanbul, 34083
About this study
Official title: The Effect of Apical Enlargement on Microbial Load Before and After Passive Ultrasonic Activation in Asymptomatic Teeth Periapical Lesions
The goal of this observational study is to define the role of apical shaping and irrigation activation on root canal cleanliness. The main questions it aims to answer are:
- does the effectiveness of irrigation activation depends on apical shaping?
- can a similar success be achieved by increasing apical shaping without irrigation activation Participants will [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items].
Read the detailed description
The aim of this study is to evaluate the effect of apical enlargement with two different diameters on the intraradicular microbiota of teeth with chronic apical periodontitis lesion before and after passive ultrasonic irrigation activation using ddPCR analysis in vivo.The study was planned as a randomized controlled clinical trial. We are planning to include 24 patients who was referred to the Istanbul Medipol University Faculty of Dentistry Endodontic Clinic with the need for root canal treatment, with asymptomatic chronic apical periodontitis. 24 patients will randomly be assigned to two groups according to the apical shaping size during root canal treatment: 25/.04 and 35/.04. Microbiological sampling of the teeth will be done with paper cones in three steps during the root canal treatment: 1. Sterility control samples (SR1) from the tooth surface after cavity preparation, 2. The first microbiological sample (S1) from the root canal after the initial file reaches the working length. 3. The second microbiological sample (S2) from the root canal after the shaping and irrigation of the root canal is finished. 4. The third microbiological sample (S3) from the root canal after the irrigation activation in the root canal is finished.The samples will be sent to the genetic analysis laboratory for further analysis in the cold chain using a Droplet Digital PCR.
- Being tested
- apical shaping size
- Keywords
- apical shaping, Droplet Digital PCR, irrigation activation, microbial load, root canal cleanliness
- Medical subject headings
- Periapical Diseases, Infections, Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apical shaping sizeProcedure or surgery
24 patients will randomly be assigned to two groups according to the apical shaping size during root canal treatment: 25/.04 and 35/.04. Microbiological sampling of the teeth will be done with paper cones in three steps during the root canal treatment: 1. Sterility control samples (SR1) from the tooth surface after cavity preparation, 2. The first microbiological sample (S1) from the root canal after the initial file reaches the working length. 3. The second microbiological sample (S2) from the root canal after the shaping and irrigation of the root canal is finished. 4. The third microbiological sample (S3) from the root canal after the irrigation activation in the root canal is finished.The samples will be sent to the genetic analysis laboratory for further analysis in the cold chain using a Droplet Digital PCR.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- One Curve Mini 25/0.4 | Root canal shaping will be completed with a heat-treated nickel titanium OneCurve Mini #25/0.4 rotary file (Micro-Mega, Besancon, France) after reaching the apical region with #10 K stainless steel files (Dentsply Maillefer, Ballaigues, Switzerland). The irrigation solution will be used by adapting an ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) to an ultrasonic device (VDW Ultra; VDW, Munich, Germany). The tip will be activated a total of three times, each cycle lasting 20 s and involving the use of 1 ml of 3% NaOCl. Then 2 ml of 17% EDTA solution will be activated for 1 minute as described above. The ultrasonic tip will be placed 2 mm shorter than the working length without touching the canal walls. Receives: Procedure: apical shaping size | |
| Group 2- One Curve Mini 35/0.4 | Root canal shaping will be completed with a heat-treated nickel titanium OneCurve Mini #35/0.4 rotary file (Micro-Mega, Besancon, France) after reaching the apical region with #10 K stainless steel files (Dentsply Maillefer, Ballaigues, Switzerland). The irrigation solution will be used by adapting an ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) to an ultrasonic device (VDW Ultra; VDW, Munich, Germany). The tip will be activated a total of three times, each cycle lasting 20 s and involving the use of 1 ml of 3% NaOCl. Then 2 ml of 17% EDTA solution will be activated for 1 minute as described above. The ultrasonic tip will be placed 2 mm shorter than the working length without touching the canal walls. Receives: Procedure: apical shaping size |
What is being measured
The primary outcome is the main question the study is designed to answer.
apical shaping size
does apical shaping size affect the microbial load in the root canal after shaping and irrigation finishes? microbial load after two different apical shaping size will be compared between two groups. Droplet Digital PCR will be used to measure and compare the microbial load within the root canal before and after irrigation protocol in each group to measure this outcome.
Measured: through study completion, an average of 1 year
irrigation activation
does irrigation activation affect the microbial load in the root canal? microbial load after chemomechanical cleaning of the root canal and after the irrigation activation will be compared. Droplet Digital PCR will be used to measure microbial load before after irrigation activation in each canal to see its effect on reduction fo microbial load within the root canal.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
the effect of apical shaping in irrigation activation
does apical size affect the irrigation activation? the microbial load after chemomechanical cleaning of the root canal and after irrigation activation will be compared between two groups (with different apical shaping size) to analyse the effect of apical shaping on irrigation activation. Droplet Digital PCR results before and after irrigation activation in root canals with different apical size will be compared to measure this outcome.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start24 Feb 2024
- Primary completion8 Jul 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal InfectionStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tan Firat Eyuboglu, Istanbul Medipol University Hospital
- Investigators
- Tan Firat Eyüboglu, PhD, JSD, Principal investigator, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035185
- Sponsor's protocol ID
- IMU-2023
- Status last verified
- Nov 2026
- First submitted
- 29 Aug 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to regulatory reasons the participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Apical Enlargement on Microbial Load Before and After Passive Ultrasonic Activation in Asymptomatic Teeth Periapical Lesions
- ClinicalTrials.gov ID
- NCT06035185
- Acronym / sponsor ID
- IMU-2023
- Keywords
- apical shaping, Droplet Digital PCR, irrigation activation, microbial load, root canal cleanliness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 24 Feb 2024 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 13 Sep 2023 (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 goal of this observational study is to define the role of apical shaping and irrigation activation on root canal cleanliness. The main questions it aims to answer are:
- does the effectiveness of irrigation activation depends on apical shaping?
- can a similar success be achieved by increasing apical shaping without irrigation activation Participants will [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items].
Detailed description
The aim of this study is to evaluate the effect of apical enlargement with two different diameters on the intraradicular microbiota of teeth with chronic apical periodontitis lesion before and after passive ultrasonic irrigation activation using ddPCR analysis in vivo.The study was planned as a randomized controlled clinical trial. We are planning to include 24 patients who was referred to the Istanbul Medipol University Faculty of Dentistry Endodontic Clinic with the need for root canal treatment, with asymptomatic chronic apical periodontitis. 24 patients will randomly be assigned to two groups according to the apical shaping size during root canal treatment: 25/.04 and 35/.04. Microbiological sampling of the teeth will be done with paper cones in three steps during the root canal treatment: 1. Sterility control samples (SR1) from the tooth surface after cavity preparation, 2. The first microbiological sample (S1) from the root canal after the initial file reaches the working length. 3. The second microbiological sample (S2) from the root canal after the shaping and irrigation of the root canal is finished. 4. The third microbiological sample (S3) from the root canal after the irrigation activation in the root canal is finished.The samples will be sent to the genetic analysis laboratory for further analysis in the cold chain using a Droplet Digital PCR.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1- One Curve Mini 25/0.4 | – | Procedure: apical shaping sizeRoot canal shaping will be completed with a heat-treated nickel titanium OneCurve Mini #25/0.4 rotary file (Micro-Mega, Besancon, France) after reaching the apical region with #10 K stainless steel files (Dentsply Maillefer, Ballaigues, Switzerland). The irrigation solution will be used by adapting an ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) to an ultrasonic device (VDW Ultra; VDW, Munich, Germany). The tip will be activated a total of three times, each cycle lasting 20 s and involving the use of 1 ml of 3% NaOCl. Then 2 ml of 17% EDTA solution will be activated for 1 minute as described above. The ultrasonic tip will be placed 2 mm shorter than the working length without touching the canal walls. |
| Group 2- One Curve Mini 35/0.4 | – | Procedure: apical shaping sizeRoot canal shaping will be completed with a heat-treated nickel titanium OneCurve Mini #35/0.4 rotary file (Micro-Mega, Besancon, France) after reaching the apical region with #10 K stainless steel files (Dentsply Maillefer, Ballaigues, Switzerland). The irrigation solution will be used by adapting an ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) to an ultrasonic device (VDW Ultra; VDW, Munich, Germany). The tip will be activated a total of three times, each cycle lasting 20 s and involving the use of 1 ml of 3% NaOCl. Then 2 ml of 17% EDTA solution will be activated for 1 minute as described above. The ultrasonic tip will be placed 2 mm shorter than the working length without touching the canal walls. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 24 patients who was referred to the Istanbul Medipol University Faculty of Dentistry Endodontic Clinic with the need for root canal treatment, with asymptomatic chronic apical periodontitis, witj clinical and radiographic findings. The study will be carried out in Istanbul Medipol University Faculty of Dentistry Endodontic Clinic, and patients with appropriate criteria will be informed about the treatment to be performed and their consent will be obtained. In this observational type study, patients treated by the same physician will be followed.
Key inclusion criteria (5 listed)
- Patients between the ages of 18-65
- Patients complying with the ASA1 and ASA2 classification (American Society of Anesthesiology)
- Patients who has molar teeth with radiolucent lesions in the periapical region
- The volunteer himself/herself or his/her legal representative wants to participate in the research by signing the 'Voluntary Consent Form'.
- Being able to tolerate the treatment physically and mentally
Key exclusion criteria (9 listed)
- Patients who have taken antibiotics/corticosteroids in the last 3 months
- Patients with systemic disease
- Teeth that cannot be properly isolated with a rubber dam
- Teeth without coronal sealing,
- Teeth with periodontal pocket depth>4 mm and teeth with crown / root fracture.
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 |
|---|---|---|
| apical shaping size24 patients will randomly be assigned to two groups according to the apical shaping size during root canal treatment: 25/.04 and 35/.04. Microbiological sampling of the teeth will be done with paper cones in three steps during the root canal treatment: 1. Sterility control samples (SR1) from the tooth surface after cavity preparation, 2. The first microbiological sample (S1) from the root canal after the initial file reaches the working length. 3. The second microbiological sample (S2) from the root canal after the shaping and irrigation of the root canal is finished. 4. The third microbiological sample (S3) from the root canal after the irrigation activation in the root canal is finished.The samples will be sent to the genetic analysis laboratory for further analysis in the cold chain using a Droplet Digital PCR. | Procedure or surgery | Group 1- One Curve Mini 25/0.4, Group 2- One Curve Mini 35/0.4 |
Primary outcome
apical shaping size
Time frame: through study completion, an average of 1 year
does apical shaping size affect the microbial load in the root canal after shaping and irrigation finishes? microbial load after two different apical shaping size will be compared between two groups. Droplet Digital PCR will be used to measure and compare the microbial load within the root canal before and after irrigation protocol in each group to measure this outcome.
irrigation activation
Time frame: through study completion, an average of 1 year
does irrigation activation affect the microbial load in the root canal? microbial load after chemomechanical cleaning of the root canal and after the irrigation activation will be compared. Droplet Digital PCR will be used to measure microbial load before after irrigation activation in each canal to see its effect on reduction fo microbial load within the root canal.
1 secondary outcome
the effect of apical shaping in irrigation activation
Time frame: through study completion, an average of 1 year
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 4 Nov 2026.
- Individual participant dataSharing planned: No. due to regulatory reasons the participant data will not be shared.
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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.
Tan Firat Eyüboglu, PhD, JSD principal investigator
Istanbul Medipol University Hospital
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 Root Canal Infection and Periapical Diseases, run by Istanbul Medipol University Hospital 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 5 inclusion and 9 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 4 Nov 2026. 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?
apical shaping size (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 4 Nov 2026.