Irrigation Activating Techniques on Irrigant Penetration Depth and Microbial Reduction

NCT06660797 | Recruiting

• 1 other identifier: Irrigation Activation
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This in-vivo study aim to evaluate effect of different irrigation activating techniques on Irrigant Penetration Depth and Microbial Reduction in root Canals

Conditions

Irrigation Activation; Endodontic Disease

Keywords

Different Irrigation Activating Techniques; primary Endodontic Infection cases

Outcome Measures

Primary Outcomes (2)

• measurment of penetration depth of irrigant

  measurment the difference between the working length and penetration depth of irrigant

  at the same 1 day visit

• measurment of bacterial reduction following different irrigation activating techniques

  collection of 3 samples followed by culturing on blood agar and counting to calculate percentage of bacterial reduction

  24-28 hours after culturing

Study Arms (3)

• Group 1: Manual dynamic agitation by matching gutta-percha master cones

ACTIVE COMPARATOR

matching gutta-percha master cones will be used in up and down motion 2mm amplitude at a frequency of 100 strokes during approximately 1 min in each prepared canal.

Other: Group1: A matching gutta-percha master cones will be used in up and down motion 2mm amplitude at a frequency of 100 strokes during approximately 1 min in each prepared canal.

Group 3: Easy Clean system activation

ACTIVE COMPARATOR

EC instrument coupled to the countrangle handpiece and operated with a micromotor at approximately 20,000 rotations per minute in continuous rotation.

Other: Group 3:EasyClean system activation : EC instrument coupled to the countrangle handpiece and operated with a micromotor at approximately 20,000 rotations per minute in continuous rotation.

Group 2: XP-endo Finisher activation

ACTIVE COMPARATOR

XP-endo Finisher used in continuous rotation for 1 minute accompanied with in-and-out movements of approximately 7-mm amplitude will be applied to the instrument according to the manufacturer's recommendations⁸

Other: Group2: XP-endo Finisher activation: The XP-endo Finisher instrument will be used in continuous rotation for 1 mintute

Interventions

Group1: A matching gutta-percha master cones will be used in up and down motion 2mm amplitude at a frequency of 100 strokes during approximately 1 min in each prepared canal. OTHER

The first microbial sample (S1) will be taken from the root canal immediately after access cavity preparation and before chemomechanical preparation.Samples will be subjected to bacterial viable count using blood agar. After complete chemomechanical preparation, a second microbial samble (S2) will be taken and managed the same way as S1.After irrigation activation protocol by matching gutta percha master cone , S3 will be collected from each root canal and managed as S1, S2 to evaluate effect of activation techniques on microbial reduction ,canals will be dried with a matching paper point then 1 mL of Iohexol (omnipaque) contrast media will be injected 2mL shorter than WL and activated by a matching gutta percha master cone , a digital radiographic image will be obtained for each tooth with the same angulation as that for WL and then the distance between WL and maximum irrigant penetration will be measured and recorded using SIDEXIS-XG software.

• Group 1: Manual dynamic agitation by matching gutta-percha master cones

Group2: XP-endo Finisher activation: The XP-endo Finisher instrument will be used in continuous rotation for 1 mintute OTHER

The first microbial sample (S1) will be taken from the root canal immediately after access cavity preparation and before chemomechanical preparation.Samples will be subjected to bacterial viable count using blood agar. After complete chemomechanical preparation, a second microbial samble (S2) will be taken and managed the same way as S1.After irrigation activation protocol by XP-endo Finisher used in continuous rotation for 1 minute , S3 will be collected from each root canal and managed as S1, S2 to evaluate effect of activation techniques on microbial reduction ,canals will be dried with a matching paper point then 1 mL of Iohexol (omnipaque) contrast media will be injected 2mL shorter than WL and activated by a matching gutta percha master cone , a digital radiographic image will be obtained for each tooth with the same angulation as that for WL and then the distance between WL and maximum irrigant penetration will be measured and recorded using SIDEXIS-XG software.

Group 2: XP-endo Finisher activation

Group 3:EasyClean system activation : EC instrument coupled to the countrangle handpiece and operated with a micromotor at approximately 20,000 rotations per minute in continuous rotation. OTHER

after access cavity preparation and before chemomechanical preparation.Samples will be subjected to bacterial viable count using blood agar. After complete chemomechanical preparation, a second microbial samble (S2) will be taken and managed the same way as S1.After irrigation activation protocol by EasyClean system activation , S3 will be collected from each root canal and managed as S1, S2 to evaluate effect of activation techniques on microbial reduction ,canals will be dried with a matching paper point then 1 mL of Iohexol (omnipaque) contrast media will be injected 2mL shorter than WL and activated by a matching gutta percha master cone , a digital radiographic image will be obtained for each tooth with the same angulation as that for WL and then the distance between WL and maximum irrigant penetration will be measured and recorded using SIDEXIS-XG software.

Group 3: Easy Clean system activation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Asymptomatic vital/non vital teeth requiring root canal treatment.
• Teeth with sound periodontal apparatus.
• Teeth without pus or inflammatory exudates draining through the canal.
• Teeth without anatomic variations.
• Teeth with sinus tract.

You may not qualify if:

• Patients with any systemic diseases.
• Pregnant or lactating patients.
• Immunocompromised patients.
• Apparently thin roots in which apical preparation with #40 or #50 file would be overzealous.
• Patient allergic to anything used in this procedure especially rubber dam material and Iohexol (radiographic contrast media).
• Retreatment cases. Teeth with calcified canals.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry

Tanta, Egypt

RECRUITING

Related Publications (2)

• Andreani Y, Gad BT, Cocks TC, Harrison J, Keresztes ME, Pomfret JK, Rees EB, Ma D, Baloun BL, Rahimi M. Comparison of irrigant activation devices and conventional needle irrigation on smear layer and debris removal in curved canals. (Smear layer removal from irrigant activation using SEM). Aust Endod J. 2021 Aug;47(2):143-149. doi: 10.1111/aej.12482. Epub 2021 Mar 8.

  PMID: 33682268 BACKGROUND

• de Souza DS, S Silva AS, Ormiga F, Lopes RT, Gusman H. The effectiveness of passive ultrasonic irrigation and the easy-clean instrument for removing remnants of filling material. J Conserv Dent. 2021 Jan-Feb;24(1):57-62. doi: 10.4103/JCD.JCD_590_20. Epub 2021 Jul 5.

  PMID: 34475681 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Ali Mahmoud Farag, Phd

  Professor of Endodontics

  PRINCIPAL INVESTIGATOR

• Dalia Abd Elhameed Sherif, Phd

  Lecturer of Endodontics

  STUDY DIRECTOR

• Kareman Ahmed Ebrahim Eshra, Phd

  Professor of clinical Microbiology and Immunology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa Samy, bachelor

CONTACT

+201020630414; alaasamy17395@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: June 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)