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CompletedNCT07607028Updated May 26, 2026

Comparison of Ultrasonic vs 980-nm Diode Laser Irrigant Activation for Reducing Residual Bacterial DNA in Necrotic Teeth

An interventional study of Ultrasonic Activation and 980-nm Diode Laser Activation in Pulp Necrosis and Root Canal Infection, sponsored by Hasanuddin University. Completed at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.

Sponsored by Hasanuddin University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Oct 2025, registered May 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Pulp necrosis is associated with microbial colonization and biofilm formation within the root canal system. Residual bacteria that persist after root canal treatment may contribute to persistent infection and unfavorable clinical outcomes. Although chemomechanical preparation and sodium hypochlorite irrigation are essential components of endodontic disinfection, anatomical complexities may limit complete bacterial elimination. Therefore, irrigant activation techniques have been introduced to improve irrigant penetration, biofilm disruption, and antimicrobial effectiveness.

Ultrasonic activation enhances irrigant movement through acoustic streaming and cavitation, whereas diode laser activation may produce additional photothermal antibacterial effects and deeper penetration into dentinal tubules. However, evidence comparing residual bacterial detection after these activation methods remains limited, particularly when evaluated using molecular identification techniques.

This exploratory randomized clinical trial compared ultrasonic irrigant activation and 980-nm diode laser irrigant activation in necrotic single-rooted teeth using 16S rRNA PCR sequencing. The study was conducted at the Dental and Oral Hospital of Hasanuddin University and the Hasanuddin University Medical Research Center, Indonesia. Sixteen necrotic single-rooted teeth were randomly allocated into two groups: ultrasonic activation (n = 8) and 980-nm diode laser activation (n = 8).

After rubber dam isolation and access preparation under aseptic conditions, initial microbial samples were collected before chemomechanical preparation. Root canal instrumentation was performed using ProGlider and ProTaper Gold rotary instruments up to F2. In both groups, canals were irrigated using 3% sodium hypochlorite. In the ultrasonic group, irrigant activation was performed using ultrasonic activation at 45 kHz for 20 seconds per cycle for three cycles. In the diode laser group, activation was performed using a 980-nm diode laser at 1.5 W for 20 seconds per cycle for three cycles. Post-treatment microbial samples were then collected.

Bacterial DNA was extracted and amplified using universal 16S rRNA primers, followed by sequencing and taxonomic identification. The primary outcome was the presence or absence of detectable oral bacterial DNA after treatment. Secondary outcomes included identification of bacterial taxa detected before and after treatment and comparison of bacterial profile reduction between activation methods.

The study was designed as an exploratory clinical-molecular investigation intended to generate preliminary evidence regarding the antibacterial effects of ultrasonic and diode laser irrigant activation in root canal disinfection.

02

Conditions studied

  • Pulp Necrosis
  • Root Canal Infection

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Keywords

  • Pulp necrosis
  • Diode laser
  • Ultrasonic activation
  • Root canal irrigation
  • 16S rRNA PCR
  • Endodontic disinfection
  • Root canal infection
  • Sodium hypochlorite
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In context

Dental Pulp Necrosis

149 studies on the registry are indexed under Dental Pulp Necrosis; 39 are open to participants now.

This study's enrollment of 16 is below the median of 45 across 140 interventional studies indexed under Dental Pulp Necrosis.

Browse Dental Pulp Necrosis studies →

Lead sponsor

Hasanuddin University is the lead sponsor of 65 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Ultrasonic Activation

    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

  • Experimental
    980-nm Diode Laser Activation

    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

  • DeviceUltrasonic Activation

    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.

  • Device980-nm Diode Laser 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.

06

What researchers measure

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.

    Time frame: Immediately after completion of irrigant activation during root canal treatment.

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Study locations

1 site
  • Dental and Oral Hospital Hasanuddin University
    Makassar, South Sulawesi 90245, Indonesia
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References and documents

Publications

  • 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. PubMed 34958494 ↗
  • 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. PubMed 34393125 ↗

Individual participant data

Plan to share: No — The IPD will not be shared because the researchers have guaranteed the confidentiality of patient data

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07607028
Lead sponsor
Hasanuddin University
Responsible party
Anjelia Gelli Bagiada (Endodontic Resident, Hasanuddin University) — Principal investigator
First posted
May 26, 2026
Start date
Oct 13, 2025
Primary completion
Feb 28, 2026
Completion
Mar 31, 2026
Last update
May 26, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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