NCT07607028

Brief Summary

This randomized clinical trial aimed to compare residual oral bacterial DNA detection after ultrasonic irrigant activation and 980-nm diode laser irrigant activation during root canal treatment of necrotic single-rooted teeth. Sixteen patients requiring endodontic treatment were randomly assigned into two groups: ultrasonic activation or 980-nm diode laser activation. Root canals were prepared using standardized chemomechanical procedures and irrigated with 3% sodium hypochlorite activated by the assigned method. Microbial samples were collected before treatment and after irrigant activation. Bacterial DNA was identified using 16S rRNA polymerase chain reaction (PCR) sequencing. The primary outcome was the presence or absence of detectable oral bacterial DNA after treatment, while the secondary outcome was the taxonomic pattern of detected bacteria before and after activation. The study was designed to explore the comparative antibacterial effects of ultrasonic and diode laser activation in infected root canals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 19, 2026

Last Update Submit

May 19, 2026

Conditions

Keywords

Pulp necrosisDiode laserUltrasonic activationRoot canal irrigation16S rRNA PCREndodontic disinfectionRoot canal infectionSodium hypochlorite

Outcome Measures

Primary Outcomes (1)

  • Presence of Detectable Oral Bacterial DNA After Irrigant Activation

    Detection of residual oral bacterial DNA in root canals after irrigant activation using ultrasonic activation or 980-nm diode laser activation, assessed by 16S rRNA PCR sequencing.

    Immediately after completion of irrigant activation during root canal treatment.

Study Arms (2)

Ultrasonic Activation

EXPERIMENTAL

Participants received root canal treatment with irrigant activation using ultrasonic activation in combination with 3% sodium hypochlorite irrigation. Ultrasonic activation was performed at 45 kHz for 20 seconds per cycle for three cycles with irrigant renewal between cycles

Device: Ultrasonic Activation

980-nm Diode Laser Activation

EXPERIMENTAL

Participants received root canal treatment with irrigant activation using a 980-nm diode laser in combination with 3% sodium hypochlorite irrigation. Laser activation was performed at 1.5 W for 20 seconds per cycle for three cycles with irrigant renewal between cycles.

Device: 980-nm Diode Laser Activation

Interventions

Ultrasonic irrigant activation was performed during root canal treatment using an ultrasonic device at 45 kHz for 20 seconds per cycle for three cycles with 3% sodium hypochlorite irrigation.

Ultrasonic Activation

Diode laser irrigant activation was performed during root canal treatment using a 980-nm diode laser at 1.5 W for 20 seconds per cycle for three cycles with 3% sodium hypochlorite irrigation.

980-nm Diode Laser Activation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years or older
  • Patients requiring endodontic treatment for mature single-rooted teeth diagnosed with pulp necrosis
  • Physically and mentally able to undergo treatment
  • No use of analgesics or antibiotics within one week before treatment
  • Teeth without clinical or radiographic evidence of apical periodontitis
  • Diagnosis confirmed by clinical examination, pulp vitality testing, and periapical radiography

You may not qualify if:

  • Teeth with mobility
  • Periodontal pockets greater than 4 mm
  • Root fracture or fracture during treatment
  • Internal or external root resorption
  • Canal calcification or canal obliteration
  • Patients with systemic conditions requiring antibiotic prophylaxis for routine dental treatment
  • Recent antimicrobial exposure that could influence microbial findings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental and Oral Hospital Hasanuddin University

Makassar, South Sulawesi, 90245, Indonesia

Location

Related Publications (2)

  • Siqueira JF Jr, Rocas IN. Present status and future directions: Microbiology of endodontic infections. Int Endod J. 2022 May;55 Suppl 3:512-530. doi: 10.1111/iej.13677. Epub 2022 Jan 13.

    PMID: 34958494BACKGROUND
  • Jambagi N, Kore P, Dhaded NS, Patil SA, Shankar M. Comparison of Antimicrobial Efficacy of Diode Laser, Ultrasonic Activated and Conventional Irrigation with 2.5% NaOCl during RCT: An Interventional Study. J Contemp Dent Pract. 2021 Jun 1;22(6):669-673.

    PMID: 34393125BACKGROUND

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
None (Open Label) Not applicable. No masking was applied in this study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned into two parallel groups to receive root canal irrigant activation using either ultrasonic activation or 980-nm diode laser activation during endodontic treatment of necrotic single-rooted teeth.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Endodontic Resident

Study Record Dates

First Submitted

May 19, 2026

First Posted

May 26, 2026

Study Start

October 13, 2025

Primary Completion

February 28, 2026

Study Completion

March 31, 2026

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

The IPD will not be shared because the researchers have guaranteed the confidentiality of patient data

Locations