Periapical PeriodontitisNCT07005219
Efficacy of Apical Preparation With Passive Ultrasonic Irrigation in Reducing Intracanal Bacteria
A study testing Root canal shaping with One Curve Mini #25/0.4 and passive ultrasonic irrigation and Root canal shaping with One Curve Mini #35/0.4 and passive ultrasonic irrigation in people with Periapical Periodontitis and Root Canal Infection, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates intracanal bacterial load in molar teeth with chronic apical periodontitis before and after root canal shaping with two different apical enlargement sizes and ultrasonic irrigation activation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Periodontitis, Root Canal Infection
- What is being tested?
- Root canal shaping with One Curve Mini #25/0.4 and passive ultrasonic irrigation and Root canal shaping with One Curve Mini #35/0.4 and passive ultrasonic irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Feb 2024to 27 Nov 2024
- Phase
- Interventional
- 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
Who may be able to join
- a non-contributory medical history
- must have an asymptomatic mandibular molar with periapical lesions of>2.0x2.0 mm around the mesial roots
- must be diagnosed as chronic apical periodontitis
Who cannot join
- Patients with acute clinical symptoms
- Teeth with previous root canal treatment
- non-restorable teeth
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Esenler, 34230
About this study
Official title: Efficacy of Minimal vs. Conventional Apical Preparation With Passive Ultrasonic Irrigation in Reducing Intracanal Bacteria: A Clinical Study
This study evaluates intracanal bacterial load in molar teeth with chronic apical periodontitis before and after root canal shaping with two different apical enlargement sizes and ultrasonic irrigation activation.
Read the detailed description
This randomized controlled clinical trial investigated the effect of different apical enlargement sizes and passive ultrasonic irrigation (PUI) on the bacterial load in the mesial roots of mandibular molars diagnosed with chronic apical periodontitis. The study was conducted at Istanbul Medipol University Faculty of Dentistry, Endodontics Clinic, and included 24 patients who required primary root canal treatment and exhibited clinical and radiographic signs of chronic apical periodontitis.
Participants were randomly assigned to two groups (n=12 each). In Group 1, root canal shaping was performed using a One Curve Mini #25/0.4 rotary file. In Group 2, shaping was performed using a One Curve Mini #35/0.4 rotary file. In both groups, passive ultrasonic irrigation was applied using the VDW Ultra device with an IRRI S 21/25 ultrasonic tip. The irrigation protocol consisted of three 20-second cycles using 1 ml of 3% sodium hypochlorite (NaOCl) per cycle. The ultrasonic tip was positioned 2 mm short of the working length without contacting the canal walls.
Bacterial samples were collected from the mesial root canals during the treatment. The bacterial load was quantified using Droplet Digital PCR (ddPCR), a highly sensitive and precise molecular technique that allows absolute quantification of bacterial DNA. This method was chosen because it enables accurate detection of bacterial reduction following the interventions.
- Conditions
- Periapical Periodontitis, Root Canal Infection
- Being tested
- Root canal shaping with One Curve Mini #25/0.4 and passive ultrasonic irrigation, Root canal shaping with One Curve Mini #35/0.4 and passive ultrasonic irrigation
- Keywords
- apical periodontitis, irrigation activation, apical enlargement, ddPCR, bacterial species
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal shaping with One Curve Mini #25/0.4 and passive ultrasonic irrigationProcedure or surgery
Participants in this group underwent root canal shaping using a One Curve Mini #25/0.4 rotary file. After mechanical preparation, passive ultrasonic irrigation (PUI) was performed using a VDW Ultra device with an IRRI S 21/25 ultrasonic tip. Irrigation was activated with 3% sodium hypochlorite (NaOCl) in three 20-second cycles, using 1 ml per cycle. The ultrasonic tip was placed 2 mm short of the working length without contacting canal walls.
Root canal shaping with One Curve Mini #35/0.4 and passive ultrasonic irrigationProcedure or surgery
Participants in this group underwent root canal shaping using a One Curve Mini #35/0.4 rotary file. The same passive ultrasonic irrigation protocol was applied as in Arm 1, using 3% NaOCl in three 20-second cycles with 1 ml per cycle. The ultrasonic tip was positioned 2 mm short of the working length without contacting the canal walls.
| Study group | Role | What they receive |
|---|---|---|
| Apical Enlargement with One Curve Mini #25/0.4 (Minimal Invasive Shaping) | Experimental | Intervention:
* Root canal shaping using One Curve Mini #25/0.4 rotary file.
* Irrigation with 3% NaOCl.
* Passive Ultrasonic Irrigation (PUI) using IRRI S 21/25 tip on VDW Ultra device.
* 3 cycles of ultrasonic activation (each 20 seconds, 1 ml NaOCl per cycle).
* Ultrasonic tip placed 2 mm short of working length, without contacting canal walls. Receives: Procedure: Root canal shaping with One Curve Mini #25/0.4 and passive ultrasonic irrigation |
| Apical Enlargement with One Curve Mini #35/0.4 (Conventional Shaping) | Experimental | Intervention:
* Root canal shaping using One Curve Mini #35/0.4 rotary file.
* Irrigation with 3% NaOCl.
* Passive Ultrasonic Irrigation (PUI) using IRRI S 21/25 tip on VDW Ultra device.
* 3 cycles of ultrasonic activation (each 20 seconds, 1 ml NaOCl per cycle).
* Ultrasonic tip placed 2 mm short of working length, without contacting canal walls. Receives: Procedure: Root canal shaping with One Curve Mini #35/0.4 and passive ultrasonic irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Bacterial Load
Quantitative reduction in bacterial load in the mesial root canals of mandibular molars with apical periodontitis, as measured by Droplet Digital PCR (ddPCR), following different apical enlargement sizes and passive ultrasonic irrigation activation, provides quantitative data that can be statistically analyzed to compare the two intervention groups (#25/0.4 vs. #35/0.4 apical enlargement).
Measured: During operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periapical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melike Yavuz, Medipol University
- Investigators
- Melike Yavuz, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005219
- Sponsor's protocol ID
- 10840098-772.02-6513
- Status last verified
- Jun 2025
- First submitted
- 22 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After its publication in a journal, we want to share our data.
Publications
Yavuz M, Eyuboglu TF, Eroglu SE, Hepsenoglu YE. The effect of apical preparation size and passive ultrasonic activation on microbial load in root canals with periapical lesions. Sci Rep. 2025 Dec 6;16(1):1264. doi: 10.1038/s41598-025-30950-1.
PubMed 41350378
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Minimal vs. Conventional Apical Preparation With Passive Ultrasonic Irrigation in Reducing Intracanal Bacteria: A Clinical Study
- ClinicalTrials.gov ID
- NCT07005219
- Acronym / sponsor ID
- 10840098-772.02-6513
- Conditions
- Periapical Periodontitis, Root Canal Infection
- Keywords
- apical periodontitis, irrigation activation, apical enlargement, ddPCR, bacterial species
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 24 Feb 2024 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 5 Jun 2025 (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.
This study evaluates intracanal bacterial load in molar teeth with chronic apical periodontitis before and after root canal shaping with two different apical enlargement sizes and ultrasonic irrigation activation.
Detailed description
This randomized controlled clinical trial investigated the effect of different apical enlargement sizes and passive ultrasonic irrigation (PUI) on the bacterial load in the mesial roots of mandibular molars diagnosed with chronic apical periodontitis. The study was conducted at Istanbul Medipol University Faculty of Dentistry, Endodontics Clinic, and included 24 patients who required primary root canal treatment and exhibited clinical and radiographic signs of chronic apical periodontitis.
Participants were randomly assigned to two groups (n=12 each). In Group 1, root canal shaping was performed using a One Curve Mini #25/0.4 rotary file. In Group 2, shaping was performed using a One Curve Mini #35/0.4 rotary file. In both groups, passive ultrasonic irrigation was applied using the VDW Ultra device with an IRRI S 21/25 ultrasonic tip. The irrigation protocol consisted of three 20-second cycles using 1 ml of 3% sodium hypochlorite (NaOCl) per cycle. The ultrasonic tip was positioned 2 mm short of the working length without contacting the canal walls.
Bacterial samples were collected from the mesial root canals during the treatment. The bacterial load was quantified using Droplet Digital PCR (ddPCR), a highly sensitive and precise molecular technique that allows absolute quantification of bacterial DNA. This method was chosen because it enables accurate detection of bacterial reduction following the interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apical Enlargement with One Curve Mini #25/0.4 (Minimal Invasive Shaping) | Experimental | Procedure: Root canal shaping with One Curve Mini #25/0.4 and passive ultrasonic irrigationIntervention: * Root canal shaping using One Curve Mini #25/0.4 rotary file. * Irrigation with 3% NaOCl. * Passive Ultrasonic Irrigation (PUI) using IRRI S 21/25 tip on VDW Ultra device. * 3 cycles of ultrasonic activation (each 20 seconds, 1 ml NaOCl per cycle). * Ultrasonic tip placed 2 mm short of working length, without contacting canal walls. |
| Apical Enlargement with One Curve Mini #35/0.4 (Conventional Shaping) | Experimental | Procedure: Root canal shaping with One Curve Mini #35/0.4 and passive ultrasonic irrigationIntervention: * Root canal shaping using One Curve Mini #35/0.4 rotary file. * Irrigation with 3% NaOCl. * Passive Ultrasonic Irrigation (PUI) using IRRI S 21/25 tip on VDW Ultra device. * 3 cycles of ultrasonic activation (each 20 seconds, 1 ml NaOCl per cycle). * Ultrasonic tip placed 2 mm short of working length, without contacting canal walls. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a non-contributory medical history
- must have an asymptomatic mandibular molar with periapical lesions of>2.0x2.0 mm around the mesial roots
- must be diagnosed as chronic apical periodontitis
Key exclusion criteria (3 listed)
- Patients with acute clinical symptoms
- Teeth with previous root canal treatment
- non-restorable teeth
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 |
|---|---|---|
| Root canal shaping with One Curve Mini #25/0.4 and passive ultrasonic irrigationParticipants in this group underwent root canal shaping using a One Curve Mini #25/0.4 rotary file. After mechanical preparation, passive ultrasonic irrigation (PUI) was performed using a VDW Ultra device with an IRRI S 21/25 ultrasonic tip. Irrigation was activated with 3% sodium hypochlorite (NaOCl) in three 20-second cycles, using 1 ml per cycle. The ultrasonic tip was placed 2 mm short of the working length without contacting canal walls. | Procedure or surgery | Apical Enlargement with One Curve Mini #25/0.4 (Minimal Invasive Shaping) |
| Root canal shaping with One Curve Mini #35/0.4 and passive ultrasonic irrigationParticipants in this group underwent root canal shaping using a One Curve Mini #35/0.4 rotary file. The same passive ultrasonic irrigation protocol was applied as in Arm 1, using 3% NaOCl in three 20-second cycles with 1 ml per cycle. The ultrasonic tip was positioned 2 mm short of the working length without contacting the canal walls. | Procedure or surgery | Apical Enlargement with One Curve Mini #35/0.4 (Conventional Shaping) |
Primary outcome
Reduction in Bacterial Load
Time frame: During operation.
Quantitative reduction in bacterial load in the mesial root canals of mandibular molars with apical periodontitis, as measured by Droplet Digital PCR (ddPCR), following different apical enlargement sizes and passive ultrasonic irrigation activation, provides quantitative data that can be statistically analyzed to compare the two intervention groups (#25/0.4 vs. #35/0.4 apical enlargement).
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 5 Jun 2025.
- Derived from this study: PubMed 41350378Yavuz M, Eyuboglu TF, Eroglu SE, Hepsenoglu YE. The effect of apical preparation size and passive ultrasonic activation on microbial load in root canals with periapical lesions. Sci Rep. 2025 Dec 6;16(1):1264. doi: 10.1038/s41598-025-30950-1.
- Individual participant dataSharing planned: Yes. After its publication in a journal, we want to share our data.
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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.
Melike Yavuz principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Root canal shaping with One Curve Mini #25/0.4 and passive ultrasonic irrigation and Root canal shaping with One Curve Mini #35/0.4 and passive ultrasonic irrigation in people with Periapical Periodontitis and Root Canal Infection, run by Medipol 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 3 inclusion and 3 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 5 Jun 2025. 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?
Reduction in Bacterial Load (time frame: During operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07005219, which also lists 1 linked publication.
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 5 Jun 2025.