Microbial Load After Apical Enlargement in Asymptomatic Teeth With Periapical Lesion

NCT06035185 | Unknown

• 1 other identifier: IMU-2023
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 irrigation activation Participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\].

Conditions

Root Canal Infection; Periapical Diseases; Periapical; Infection; Endodontic Disease

Keywords

apical shaping; Droplet Digital PCR; irrigation activation; microbial load; root canal cleanliness

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• the effect of apical shaping in irrigation activation

  through study completion, an average of 1 year

Study Arms (2)

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

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

Interventions

apical shaping size PROCEDURE

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 1- One Curve Mini 25/0.4; Group 2- One Curve Mini 35/0.4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University School of Dentistry

Istanbul, 34083, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Diseases; Infections; Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases

Study Officials

• Tan Firat Eyüboglu, PhD, JSD

  Istanbul Medipol University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tan Firat Eyüboglu

CONTACT

+905304636059; tfeyuboglu@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 13, 2023
• Study Start: December 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)