Pulp NecrosisNCT07607028
Comparison of Ultrasonic vs 980-nm Diode Laser Irrigant Activation for Reducing Residual Bacterial DNA in Necrotic Teeth
A study testing Ultrasonic Activation and 980-nm Diode Laser Activation in people with Pulp Necrosis and Root Canal Infection, run by Hasanuddin University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulp Necrosis, Root Canal Infection
- What is being tested?
- Ultrasonic Activation and 980-nm Diode Laser Activation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteIndonesia
- Study dates
- 13 Oct 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dental and Oral Hospital Hasanuddin University
Makassar, South Sulawesi, 90245
About this study
Official title: Residual Bacterial DNA Detection After Ultrasonic vs 980-nm Diode Laser Irrigant Activation in Necrotic Teeth: A Pilot Randomized Clinical Study
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.
- Conditions
- Pulp Necrosis, Root Canal Infection
- Being tested
- Ultrasonic Activation, 980-nm Diode Laser Activation
- Keywords
- Pulp necrosis, Diode laser, Ultrasonic activation, Root canal irrigation, 16S rRNA PCR, Endodontic disinfection, Root canal infection, Sodium hypochlorite
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic ActivationDevice
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.
980-nm Diode Laser ActivationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: 980-nm Diode Laser Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after completion of irrigant activation during root canal treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start13 Oct 2025
- Primary completion28 Feb 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulp NecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anjelia Gelli Bagiada, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607028
- Sponsor's protocol ID
- No. 265/KEPK FKG-RSGMP UH/EA/I
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will not be shared because the researchers have guaranteed the confidentiality of patient data
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 34958494Jambagi 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
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Bacterial DNA Detection After Ultrasonic vs 980-nm Diode Laser Irrigant Activation in Necrotic Teeth: A Pilot Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07607028
- Acronym / sponsor ID
- No. 265/KEPK FKG-RSGMP UH/EA/I
- Conditions
- Pulp Necrosis, Root Canal Infection
- Keywords
- Pulp necrosis, Diode laser, Ultrasonic activation, Root canal irrigation, 16S rRNA PCR, Endodontic disinfection, Root canal infection, Sodium hypochlorite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ultrasonic Activation | Experimental | Device: Ultrasonic ActivationParticipants 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 |
| 980-nm Diode Laser Activation | Experimental | Device: 980-nm Diode Laser ActivationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonic ActivationUltrasonic 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. | Device | Ultrasonic Activation |
| 980-nm Diode Laser ActivationDiode 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. | Device | 980-nm Diode Laser Activation |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 34958494Siqueira 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.
- Background: PubMed 34393125Jambagi 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.
- Individual participant dataSharing planned: No. The IPD will not be shared because the researchers have guaranteed the confidentiality of patient data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic Activation and 980-nm Diode Laser Activation in people with Pulp Necrosis and Root Canal Infection, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Detectable Oral Bacterial DNA After Irrigant Activation (time frame: Immediately after completion of irrigant activation during root canal treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07607028, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.