- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07607028
Comparison of Ultrasonic vs 980-nm Diode Laser Irrigant Activation for Reducing Residual Bacterial DNA in Necrotic Teeth
Residual Bacterial DNA Detection After Ultrasonic vs 980-nm Diode Laser Irrigant Activation in Necrotic Teeth: A Pilot Randomized Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
South Sulawesi
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Makassar, South Sulawesi, Indonesia, 90245
- Dental and Oral Hospital Hasanuddin University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
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.
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of Detectable Oral Bacterial DNA After Irrigant Activation
Time Frame: Immediately after completion of irrigant activation during root canal treatment.
|
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.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- No. 265/KEPK FKG-RSGMP UH/EA/I
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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