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Primary Apical PeriodontitisNCT07637305

Bacterial Profiles in Primary Apical Periodontitis Using 16S rRNA PCR

A study testing 3% Sodium Hypochlorite Irrigation with Ultrasonic Activation and 5.25% Sodium Hypochlorite Irrigation with Ultrasonic Activation in people with Primary Apical Periodontitis and Root Canal Infection, run by Hasanuddin University at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot randomized clinical study aims to compare bacterial profiles in symptomatic and asymptomatic primary apical periodontitis using 16S rRNA polymerase chain reaction sequencing. Read more about this study

Who is it for?
Ages 18 to 40 years
What is being tested?
3% Sodium Hypochlorite Irrigation with Ultrasonic Activation and 5.25% Sodium Hypochlorite Irrigation with Ultrasonic Activation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 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 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adult patients who are mentally and physically healthy, aged 18-40 years.
  • Mature permanent molar teeth diagnosed with symptomatic or asymptomatic apical periodontitis, determined based on:
  • Patient history; Intraoral clinical examination; For symptomatic apical periodontitis: negative pulp vitality test, negative palpation test, positive percussion test, with or without widening of the periodontal ligament space; For asymptomatic apical periodontitis: negative pulp vitality test, negative palpation test, percussion test findings, and radiographic assessment using a periapical index score of less than 5 based on periapical radiographs.
  • Teeth with straight root canals. Teeth that are restorable after root canal treatment. Patients who are willing to participate in the study and have signed the informed consent form after receiving an explanation of the study.

Who cannot join

  • Participants will be excluded if the tooth or patient presents with any of the following conditions:
  • Patients who have taken antibiotics within 7 days before sample collection. Advanced tooth mobility greater than grade 2. Periodontal pockets greater than 4 mm. Teeth with previous endodontic treatment. Root fracture or fracture occurring during root canal treatment. Teeth showing internal or external resorption. Teeth with open apices. Teeth with calcified or obliterated root canals. Patients with systemically compromised conditions requiring antibiotic coverage for routine dental treatment or patients with systemic diseases.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site
  • Dental and Oral Hospital of Hasanuddin University

    Makassar, South Sulawesi, 90245

Other trials in Indonesia

About this study

Official title: Comparative Analysis of Bacterial Profiles in Symptomatic and Asymptomatic Primary Apical Periodontitis Using 16S rRNA Polymerase Chain Reaction: A Pilot Randomized Clinical Study

This pilot randomized clinical study aims to compare bacterial profiles in symptomatic and asymptomatic primary apical periodontitis using 16S rRNA polymerase chain reaction sequencing. Twenty-four mandibular first molars requiring endodontic treatment will be selected from patients attending the Conservative Dentistry Clinic at the Dental and Oral Hospital of Hasanuddin University. The samples will be divided into two diagnostic groups: symptomatic primary apical periodontitis and asymptomatic primary apical periodontitis. Each diagnostic group will then be allocated into two irrigation groups using either 3% or 5.25% sodium hypochlorite.

Microbial samples will be collected from the distal root canal at three time points: before root canal treatment, after chemomechanical preparation and sodium hypochlorite irrigation with ultrasonic activation, and two weeks after intracanal calcium hydroxide medication. Root canal samples will be subjected to bacterial DNA extraction, 16S rRNA PCR amplification, sequencing, and taxonomic identification.

The primary outcome is the presence or absence of detectable bacterial DNA at each sampling stage. Secondary outcomes include the bacterial taxa identified in symptomatic and asymptomatic primary apical periodontitis and changes in bacterial profiles after sodium hypochlorite irrigation and calcium hydroxide medication. The study is designed to provide preliminary clinical-molecular evidence on bacterial profile changes during endodontic treatment of primary apical periodontitis.

Read the detailed description

rimary apical periodontitis is commonly associated with microbial infection of the root canal system. The bacterial community in primary endodontic infections is complex and may differ between symptomatic and asymptomatic cases. Persistent bacteria after chemomechanical preparation and intracanal medication may contribute to continuing periapical inflammation and unfavorable endodontic outcomes. Therefore, molecular identification of bacterial profiles during different stages of root canal treatment is important to better understand the microbial changes associated with endodontic disinfection.

Sodium hypochlorite is widely used as an endodontic irrigant because of its antimicrobial and tissue-dissolving properties. Different concentrations of sodium hypochlorite may influence bacterial reduction within the root canal system. In addition, ultrasonic activation may improve irrigant penetration and enhance disinfection by promoting acoustic streaming and disruption of bacterial biofilm. Calcium hydroxide is also commonly used as an intracanal medicament between appointments because of its high alkalinity and antibacterial activity.

This pilot randomized clinical study will evaluate bacterial profiles in mandibular first molars with primary apical periodontitis. A total of 24 mandibular first molars requiring endodontic treatment will be included from patients attending the Conservative Dentistry Clinic at the Dental and Oral Hospital of Hasanuddin University. The samples will be selected using purposive sampling based on predefined inclusion and exclusion criteria.

The samples will be divided into two diagnostic groups: 12 teeth with symptomatic primary apical periodontitis and 12 teeth with asymptomatic primary apical periodontitis. Each diagnostic group will then be divided according to the concentration of sodium hypochlorite irrigation, resulting in four treatment groups. Group 1 will consist of six mandibular first molars with symptomatic apical periodontitis irrigated with 3% sodium hypochlorite. Group 2 will consist of six mandibular first molars with symptomatic apical periodontitis irrigated with 5.25% sodium hypochlorite. Group 3 will consist of six mandibular first molars with asymptomatic apical periodontitis irrigated with 3% sodium hypochlorite. Group 4 will consist of six mandibular first molars with asymptomatic apical periodontitis irrigated with 5.25% sodium hypochlorite.

After communication, information, education, and informed consent, root canal treatment will be performed under aseptic conditions. The operative field will be isolated using a rubber dam, followed by disinfection of the working area. Access opening will be performed, and the mesial canal orifices will be isolated to allow sampling from the distal root canal. Working length will be determined using a K-file and apex locator, then confirmed radiographically. The first microbial sample will be collected from the distal root canal before chemomechanical preparation and labeled as S1. The sampling procedure and subsequent laboratory analysis are described in the uploaded research procedure, including collection using endodontic files and storage in DNA Shield before PCR examination.

Root canal preparation will be performed using rotary ProTaper Gold instruments up to F2. After instrumentation, the canals will be irrigated according to the assigned group using either 3% or 5.25% sodium hypochlorite. The irrigation protocol will include sodium hypochlorite, sterile distilled water, 17% EDTA, and sterile distilled water, followed by ultrasonic activation for 20 seconds per cycle for three cycles. The second microbial sample will be collected after chemomechanical preparation and irrigation, then labeled as S2.

After S2 sampling, intracanal medication with calcium hydroxide will be placed in the root canal. The tooth will be sealed with a cotton pellet and temporary restoration for 14 days. At the second visit, the tooth will be isolated and disinfected again, the temporary restoration will be removed, and calcium hydroxide will be cleaned from the canal using sterile distilled water. The third microbial sample will be collected from the distal root canal two weeks after calcium hydroxide medication and labeled as S3.

Bacterial identification will be performed using 16S rRNA polymerase chain reaction sequencing. DNA will be extracted from the samples, followed by PCR amplification using universal bacterial primers. The PCR process will include pre-denaturation, denaturation, annealing, extension, and final extension steps. PCR products will then be evaluated using gel electrophoresis. Positive amplified products will be further processed for sequencing and taxonomic identification by comparing DNA sequences with available sequence databases.

The primary outcome of this study is the presence or absence of detectable bacterial DNA in root canal samples at the three sampling stages: before treatment, after sodium hypochlorite irrigation, and after calcium hydroxide medication. Secondary outcomes include the identification of bacterial taxa in symptomatic and asymptomatic primary apical periodontitis, comparison of bacterial profiles between 3% and 5.25% sodium hypochlorite irrigation groups, and evaluation of bacterial profile changes from S1 to S2 and S3.

This study is designed as a pilot clinical-molecular investigation to generate preliminary evidence regarding bacterial profile changes during endodontic treatment of primary apical periodontitis. The findings are expected to provide useful information on the microbial characteristics of symptomatic and asymptomatic primary apical periodontitis and the effect of standard endodontic disinfection procedures on bacterial detection using 16S rRNA PCR sequencing.

Being tested
3% Sodium Hypochlorite Irrigation with Ultrasonic Activation, 5.25% Sodium Hypochlorite Irrigation with Ultrasonic Activation
Keywords
Periapical Periodontitis, Root canal infection, Sodium Hypochlorite, Calcium Hydroxide, Polymerase Chain Reaction, RNA, Ribosomal, 16S, DNA, Bacterial, Molecular Diagnostic Techniques
Medical subject headings
Periapical Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3% Sodium Hypochlorite Irrigation with Ultrasonic ActivationDrug

    Root canals will be prepared using rotary ProTaper Gold instruments up to F2. Irrigation will be performed using 3% sodium hypochlorite, followed by sterile distilled water, 17% EDTA, and sterile distilled water. The irrigant will be activated ultrasonically for 20 seconds per cycle for three cycles. Microbial samples will be collected before treatment, after irrigation, and two weeks after calcium hydroxide intracanal medication.

  • 5.25% Sodium Hypochlorite Irrigation with Ultrasonic ActivationDrug

    Root canals will be prepared using rotary ProTaper Gold instruments up to F2. Irrigation will be performed using 5.25% sodium hypochlorite, followed by sterile distilled water, 17% EDTA, and sterile distilled water. The irrigant will be activated ultrasonically for 20 seconds per cycle for three cycles. Microbial samples will be collected before treatment, after irrigation, and two weeks after calcium hydroxide intracanal medication.

Study groups in NCT07637305
Study groupRoleWhat they receive
Symptomatic Apical Periodontitis with 3% Sodium HypochloriteExperimentalParticipants with mandibular first molars diagnosed with symptomatic primary apical periodontitis will receive root canal treatment with 3% sodium hypochlorite irrigation.
Receives: Drug: 3% Sodium Hypochlorite Irrigation with Ultrasonic Activation
Symptomatic Apical Periodontitis with 5.25% Sodium HypochloriteExperimentalParticipants with mandibular first molars diagnosed with symptomatic primary apical periodontitis will receive root canal treatment with 5.25% sodium hypochlorite irrigation.
Receives: Drug: 5.25% Sodium Hypochlorite Irrigation with Ultrasonic Activation
Asymptomatic Apical Periodontitis with 3% Sodium HypochloriteExperimentalParticipants with mandibular first molars diagnosed with asymptomatic primary apical periodontitis will receive root canal treatment with 3% sodium hypochlorite irrigation.
Receives: Drug: 3% Sodium Hypochlorite Irrigation with Ultrasonic Activation
Asymptomatic Apical Periodontitis with 5.25% Sodium HypochloriteExperimentalParticipants with mandibular first molars diagnosed with asymptomatic primary apical periodontitis will receive root canal treatment with 5.25% sodium hypochlorite irrigation.
Receives: Drug: 5.25% Sodium Hypochlorite Irrigation with Ultrasonic Activation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Detection of Bacterial DNA in Root Canal Samples

    The presence or absence of detectable bacterial DNA will be assessed using 16S rRNA PCR sequencing in distal root canal samples collected before treatment, after sodium hypochlorite irrigation with ultrasonic activation, and two weeks after intracanal calcium hydroxide medication.

    Measured: Baseline, immediately after irrigation, and 2 weeks after intracanal calcium hydroxide medication

Secondary outcomes (1)
  1. Bacterial Profile Changes During Endodontic Treatment

    Bacterial taxa identified by 16S rRNA PCR sequencing will be compared between symptomatic and asymptomatic primary apical periodontitis groups and between 3% and 5.25% sodium hypochlorite irrigation groups across the three sampling stages.

    Measured: Baseline, immediately after irrigation, and 2 weeks after intracanal calcium hydroxide medication

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2026
  2. Study start13 Oct 2025
  3. Primary completion28 Feb 2026
  4. Study completion31 Mar 2026

Resources

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 with mandibular first molars diagnosed with symptomatic or asymptomatic primary apical periodontitis will be assigned to receive root canal irrigation using either 3% sodium hypochlorite or 5.25% sodium hypochlorite during endodontic treatment. Microbial samples will be collected from the distal root canal before treatment, after chemomechanical preparation and sodium hypochlorite irrigation with ultrasonic activation, and two weeks after intracanal calcium hydroxide medication. Bacterial profiles will be identified using 16S rRNA polymerase chain reaction sequencing.
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07637305
Sponsor's protocol ID
265/KEPK FKG-RSGMP UH/EA/I
Status last verified
Jun 2026
First submitted
4 Jun 2026
Last updated
9 Jun 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

  • Alquria TA, Acharya A, Tordik P, Griffin I, Martinho FC. Impact of root canal disinfection on the bacteriome present in primary endodontic infection: A next generation sequencing study. Int Endod J. 2024 Aug;57(8):1124-1135. doi: 10.1111/iej.14074. Epub 2024 May 3.

    PubMed 38700876
  • 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

Questions about this trial

What is this clinical trial studying?

A study testing 3% Sodium Hypochlorite Irrigation with Ultrasonic Activation and 5.25% Sodium Hypochlorite Irrigation with Ultrasonic Activation in people with Primary Apical Periodontitis 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 4 inclusion and 2 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 9 Jun 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?

Detection of Bacterial DNA in Root Canal Samples (time frame: Baseline, immediately after irrigation, and 2 weeks after intracanal calcium hydroxide medication). 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 NCT07637305, 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 9 Jun 2026.

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