NCT07420920

Brief Summary

The goal of this clinical trial is to is to assess the antibacterial effect of sodium hypochlorite heated inside root canals of necrotic teeth using various activation techniques The main question it aims to answer is: Does the antibacterial effect vary following various standardized techniques of intracanal heating of sodium hypochlorite in endodontic treatment?

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
1mo left

Started Feb 2026

Shorter than P25 for phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Feb 2026Jun 2026

First Submitted

Initial submission to the registry

February 3, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

February 10, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 3, 2026

Last Update Submit

February 11, 2026

Conditions

Necrotic Teeth

Keywords

Necrotic teeth,Endodontic irriggationIrrigation activationIntracanal heatingSodium hypochlorite

Outcome Measures

Primary Outcomes (1)

  • Bacterial reduction

    Antibacterial effect is evaluated by counting number of bacterial colonies, samples are collected and placed in brain-heart infusion (BHI) broth and subjected to microbiological analysis to determine the colony-forming unit (CFU)/ml

    after treatment, samples are sent to microbiology lab and bacterial count is measured day 1 after treatment.

Secondary Outcomes (1)

  • Post-operative pain

    Post operative pain is measured until day 3 after treatment

Study Arms (3)

Intracanal heating for activation using ultrasonics

ACTIVE COMPARATOR
Device: Ultrasonic activation

Intracanal heating for activation using System-B heat carrier

EXPERIMENTAL
Device: System-B

Intracanal heating for activation using a combination of ultrasonics and System-B

EXPERIMENTAL
Device: System-BDevice: Ultrasonic activation

Interventions

System-BDEVICE

The irrigation activation by heating is achieved using System-B heat carrier

Intracanal heating for activation using System-B heat carrierIntracanal heating for activation using a combination of ultrasonics and System-B
Ultrasonic activationDEVICE

Activation of irrigation using ultrasonic

Intracanal heating for activation using a combination of ultrasonics and System-BIntracanal heating for activation using ultrasonics

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • For patients:
  • adult male or female patients
  • medically free.
  • For selected teeth:
  • asymptomatic necrotic single rooted teeth
  • teeth with mature root
  • restorable teeth.

You may not qualify if:

  • For patients:
  • Patients with dental related symptoms
  • patients with chronic or systemic diseases
  • pregnant females.
  • For selected teeth:
  • multirooted teeth
  • vital teeth
  • teeth with incompletely formed roots
  • teeth with internal or external resorption
  • previously root canal treated teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Govindaraju, L., Shruthi, S.T., Gopal, R., Jenarthanan, S., Rajendran, M.R., 2024. Does increase in temperature of sodium hypochlorite have enhanced antimicrobial efficacy and tissue dissolution property?-A systematic review and meta-regression. J. Conserv. Dent. Endod. 27, 675-684. https://doi.org/10.4103/JCDE.JCDE_110_24

    BACKGROUND

  • Iandolo, A., Amato, M., Dagna, A., Poggio, C., Abdellatif, D., Franco, V., Pantaleo, G., 2018. Intracanal heating of sodium hypochlorite: Scanning electron microscope evaluation of root canal walls. J. Conserv. Dent. 21, 569. https://doi.org/10.4103/JCD.JCD_245_18

    BACKGROUND

  • Rathore, V., Samel, D., Moogi, P., Bandekar, S., Kshirsagar, S., Vyas, C., 2020. Antimicrobial efficacy of intracanal and extracanal heated sodium hypochlorite against Enterococcus faecalis: An in vitro study. Endodontology 32, 112-117. https://doi.org/10.4103/endo.endo_21_20

    BACKGROUND

  • Yared, G., Al Asmar Ramli, G., 2020. Antibacterial Ability of Sodium Hypochlorite Heated in the Canals of Infected Teeth: An Ex Vivo Study. Cureus. https://doi.org/10.7759/cureus.6975

    BACKGROUND

  • Simeone, M., Valletta, A., Giudice, A., Di Lorenzo, P., Iandolo, A., 2015. The activation of irrigation solutions in Endodontics: A perfected technique. G. Ital. Endod. 29, 65-69. https://doi.org/10.1016/j.gien.2015.08.005

    BACKGROUND

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 19, 2026

Study Start

February 10, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02