Microbial Load After Apical Enlargement in Asymptomatic Teeth With Periapical Lesion

Endodontic Disease Clinical Trial

Official title:

The Effect of Apical Enlargement on Microbial Load Before and After Passive Ultrasonic Activation in Asymptomatic Teeth Periapical Lesions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06035185
• Other study ID #: IMU-2023
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: September 2023
• Source: Istanbul Medipol University Hospital
• Contact: Tan Firat Eyüboglu
• Phone: +905304636059
• Email: tfeyuboglu[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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].

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Dental Pulp Diseases
• Endodontic Disease
• Infections
• Periapical Diseases
• Periapical; Infection
• Root Canal Infection

Intervention

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.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University School of Dentistry	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	through study completion, an average of 1 year