Microbial Load After Apical Enlargement in Asymptomatic Teeth With Periapical Lesion

September 6, 2023 updated by: Tan Firat Eyuboglu, Istanbul Medipol University Hospital

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].

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey, 34083
        • Istanbul Medipol University School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the effect of apical shaping in irrigation activation
Time Frame: through study completion, an average of 1 year
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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Investigators

  • Principal Investigator: Tan Firat Eyüboglu, PhD, JSD, Istanbul Medipol University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMU-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

due to regulatory reasons the participant data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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