NCT07056127

Brief Summary

This randomized clinical study aims to evaluate microbial reduction in root canals after using different final irrigation activation techniques including passive ultrasonic irrigation, XP-endo Finisher file and Laser ablation with Indocyanine green dye in comparison to manual dynamic activation.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

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 Progress71%
Aug 2025Sep 2026

First Submitted

Initial submission to the registry

June 28, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 9, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

July 9, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

June 28, 2025

Last Update Submit

June 28, 2025

Conditions

Keywords

Irrigant activation, ultrasonic, xp-endo finisher

Outcome Measures

Primary Outcomes (1)

  • bacterial count

    24-48 hours

Study Arms (4)

manual dynamic agitation

ACTIVE COMPARATOR
Other: manual dynamic agitaion

ultrasonic activation

ACTIVE COMPARATOR
Other: ultrasonic activation

xp-endo finisher

ACTIVE COMPARATOR
Other: xp-endo finisher

laser

ACTIVE COMPARATOR
Other: laser

Interventions

5 mL of 2.5% NaOCl solution will be activated with a well-fitting gutta-percha cone that will be placed to full working length and then will be moved in push-pull strokes of 2 mm amplitude at a frequency of 100 strokes in about 1 min

manual dynamic agitation

5 mL of 5.25% NaOCl solution will be activated with PUI using a #20 endosonic file that will be driven by an ultrasonic device on medium power setting for 1 minute and inserted 1 mm short of the working length

ultrasonic activation

5 mL of 5.25% NaOCl solution will be activated with XP-Endo Finisher which will be used in the canal for 1 minute at 800 rpm and 1 Ncm up to the working length and in slow up-and-down movements at 7-8mm length according to the manufacturer's recommendations

xp-endo finisher
laserOTHER

First, root canals will be filled with 0.5 mL of 0.05% ICG dye and left in place for 1 minute as preirradiation time. A #20 laser fiber will be inserted into the root canals to the working length. Then infrared diode laser with a wave length of 810 nm will be used to activate the dye for 30 seconds. For activation, circular movements will be performed along with the fiber removal movement . After the first activation, dye will be reintroduced, the laser fiber will be inserted again, and a new activation cycle of 30 seconds will be performed similarly to the previous one

laser

Eligibility Criteria

Age15 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Vital/non vital single rooted teeth with single root canal with nearly the same apical diameter requiring root canal treatment.
  • Teeth with sound periodontal apparatus.

You may not qualify if:

  • Teeth with anatomic anomilies.
  • Retreatment cases
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry

Tanta, Egypt

Location

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant teacher

Study Record Dates

First Submitted

June 28, 2025

First Posted

July 9, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

July 9, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations