Microbial Load After Apical Enlargement in Asymptomatic Teeth With Periapical Lesion
NCT ID: NCT06035185
Last Updated: 2023-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
24 participants
OBSERVATIONAL
2023-12-01
2025-12-30
Brief Summary
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* 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 \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\].
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
apical shaping size
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.
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.
apical shaping size
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.
Interventions
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apical shaping size
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Istanbul Medipol University Hospital
OTHER
Responsible Party
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Tan Firat Eyuboglu
Associate Professor
Principal Investigators
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Tan Firat Eyüboglu, PhD, JSD
Role: PRINCIPAL_INVESTIGATOR
Istanbul Medipol University Hospital
Locations
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Istanbul Medipol University School of Dentistry
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Other Identifiers
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IMU-2023
Identifier Type: -
Identifier Source: org_study_id
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