Chronic Apical AbscessBactProfil-RCTNCT07623278
Bacterial Profile Changes During Different Sodium Hypochlorite Irrigation Regimens and Calcium Hydroxide Medicament in Root Canal Treatment
A study testing Root canal treatment with 5.25% sodium hypochlorite irrigation and Root canal treatment with 3% sodium hypochlorite irrigation in people with Chronic Apical Abscess and Root Canal Infection, run by Hasanuddin University at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to learn how the bacterial profile in infected root canals changes during different phases of routine root canal treatment in adults with chronic apical abscess. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Apical Abscess, Root Canal Infection
- What is being tested?
- Root canal treatment with 5.25% sodium hypochlorite irrigation and Root canal treatment with 3% sodium hypochlorite irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndonesia
- Study dates
- 13 Oct 2025to 18 May 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult aged between 18 and 75 years.
- Physically and mentally able to undergo treatment
- Have not used antibiotics within 1 week before treatment.
- Permanent molar teeth showing clinical and radiographic signs of chronic apical abscess and considered restorable.
- Willing to participate in the study and able to provide written informed consent after receiving an explanation of the study.
Who cannot join
- Systemic conditions that require antibiotic prophylaxis for routine dental treatment or other significant systemic disease.
- Pregnant or breastfeeding women.
- Participants with cognitive impairment.
- Teeth with advanced mobility (greater than grade 2).
- Teeth with periodontal pockets deeper than 4 mm.
- Teeth with radiographic signs of root resorption.
Show all 9Show fewer
- Teeth with calcification or obliteration of the root canal.
- Teeth with root fracture or that fracture during treatment.
- Teeth with open apices.
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: Bacterial Profile Changes During Root Canal Treatment With 5.25% and 3% Sodium Hypochlorite Irrigation and Calcium Hydroxide Medicament Assessed by 16S rRNA PCR
The goal of this clinical trial is to learn how the bacterial profile in infected root canals changes during different phases of routine root canal treatment in adults with chronic apical abscess. The main questions it aims to answer are:
- How does the root canal bacterial profile change before and after irrigation with 5.25 percent sodium hypochlorite or 3 percent sodium hypochlorite?
- How does the bacterial profile change after calcium hydroxide medicament is placed in the root canal?
Read more
Participants will:
- Receive standard root canal treatment with one of two irrigation regimens (5.25 percent or 3 percent sodium hypochlorite, plus EDTA),
- Have root canal samples taken three times (before any treatment, after irrigation, and after calcium hydroxide medicament), and
- Have the bacteria in these samples analyzed using 16S rRNA PCR and DNA sequencing.
Read the detailed description
Chronic apical abscess is associated with complex multispecies biofilms in the root canal that can differ between populations and are not fully characterized by conventional culture methods. This study focuses on adult patients with necrotic molar teeth and chronic apical abscess treated at the Dental and Oral Hospital, Faculty of Dentistry, Hasanuddin University. The main objective is to describe how the root canal bacterial community profile changes during different phases of routine root canal treatment using 16S rRNA PCR and sequence analysis.
The study uses a descriptive and analytic repeated-measures design. At least 24 adult outpatients with necrotic pulp and chronic apical abscess who meet the inclusion and exclusion criteria will be recruited and provide written informed consent. After rubber dam isolation, access cavity preparation, and working length determination, the first root canal sample (S1) is collected from the distal canal using a sterile Hedström file and transferred into a tube containing DNA preservative solution. Mechanical preparation is then performed with rotary instruments. Patients are randomly assigned by clinic staff, who are blinded to the investigator, to one of two irrigation regimens: 5.25 percent sodium hypochlorite or 3 percent sodium hypochlorite, each followed by sterile distilled water, 17 percent EDTA, and a final rinse with sterile distilled water. A second sample (S2) is collected from the same canal after irrigation. Calcium hydroxide intracanal medicament is then placed and the tooth is temporized.
After approximately two weeks, the temporary restoration and calcium hydroxide are removed, and a third sample (S3) is collected from the same canal using a sterile Hedström file. All samples are stored in DNA preservative solution and analyzed by 16S rRNA PCR followed by DNA sequencing to characterize the bacterial community composition and diversity. The study will compare bacterial taxa and community profiles at S1, S2, and S3 and between the two sodium hypochlorite concentrations in order to explore how root canal irrigation and calcium hydroxide medicament are associated with changes in the bacterial community.
- Conditions
- Chronic Apical Abscess, Root Canal Infection
- Being tested
- Root canal treatment with 5.25% sodium hypochlorite irrigation, Root canal treatment with 3% sodium hypochlorite irrigation
- Keywords
- root canal treatment, chronic apical abscess, sodium hypochlorite irrigation, calcium hydroxide, 16S rRNA PCR, root canal microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal treatment with 5.25% sodium hypochlorite irrigationProcedure or surgery
Standard root canal procedure in which the canal is irrigated with 5.25 percent sodium hypochlorite, followed by sterile distilled water and 17 percent EDTA, then calcium hydroxide intracanal medicament and final obturation, with bacterial sampling at three time points.
Root canal treatment with 3% sodium hypochlorite irrigationProcedure or surgery
Standard root canal procedure in which the canal is irrigated with 3 percent sodium hypochlorite, followed by sterile distilled water and 17 percent EDTA, then calcium hydroxide intracanal medicament and final obturation, with bacterial sampling at three time points.
| Study group | Role | What they receive |
|---|---|---|
| 5.25% sodium hypochlorite Irrigation | Experimental | Participants received standard root canal treatment for molar teeth with chronic apical abscess using irrigation with 5.25 percent sodium hypochlorite. The procedure includes mechanical preparation, rinsing with sterile distilled water and 17 percent EDTA, placement of calcium hydroxide intracanal medicament, and final obturation. Root canal samples are collected from the same canal before treatment, after irrigation, and after calcium hydroxide medicament. Receives: Procedure: Root canal treatment with 5.25% sodium hypochlorite irrigation |
| 3% sodium hypochloritel Irrigation | Experimental | Participants received standard root canal treatment for molar teeth with chronic apical abscess using irrigation with 3 percent sodium hypochlorite. The procedure includes mechanical preparation, rinsing with sterile distilled water and 17 percent EDTA, placement of calcium hydroxide intracanal medicament, and final obturation. Root canal samples are collected from the same canal before treatment, after irrigation, and after calcium hydroxide medicament. Receives: Procedure: Root canal treatment with 3% sodium hypochlorite irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in root canal bacterial community profile
Bacterial community composition and diversity in root canal samples from molar teeth with chronic apical abscess, assessed using 16S rRNA PCR and DNA sequencing at three time points (before treatment, after irrigation, and after calcium hydroxide medicament).
Measured: Baseline/S1 (before any treatment), immediately after irrigation (S2), and approximately 2 weeks after calcium hydroxide medicament (S3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start13 Oct 2025
- Primary completion30 Mar 2026
- Study completion18 May 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 Chronic Apical AbscessStudies 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
- Two parallel groups of adults with chronic apical abscess receive standard root canal treatment with different sodium hypochlorite irrigation concentrations (5.25 percent or 3 percent). Root canal samples are collected three times from the same canal to compare changes in the bacterial community profile over time.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatrix Zitzy Uniquen Enoch, Hasanuddin University
- Investigators
- Beatrix Zitzy Uniquen Enoch, DDS, Principal investigator, Dental and Oral Hospital Hasanuddin UniversityProf. Maria Tanumihardja, DDS, MDS, Study director, Dental and Oral Hospital Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623278
- Sponsor's protocol ID
- 265/KEPK FKG-RSGMP UH/EA/IX/20
- Acronym
- BactProfil-RCT
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of privacy considerations and institutional and ethics committee policies that restrict sharing of identifiable clinical data outside the study team.
Publications
Wang, X., et al. (2023). Longitudinal Analysis of Root Canal Microbiome Using 16S rRNA Sequencing. Journal of Endodontics.
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Profile Changes During Root Canal Treatment With 5.25% and 3% Sodium Hypochlorite Irrigation and Calcium Hydroxide Medicament Assessed by 16S rRNA PCR
- ClinicalTrials.gov ID
- NCT07623278
- Acronym / sponsor ID
- BactProfil-RCT / 265/KEPK FKG-RSGMP UH/EA/IX/20
- Conditions
- Chronic Apical Abscess, Root Canal Infection
- Keywords
- root canal treatment, chronic apical abscess, sodium hypochlorite irrigation, calcium hydroxide, 16S rRNA PCR, root canal microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 3 Jun 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.
The goal of this clinical trial is to learn how the bacterial profile in infected root canals changes during different phases of routine root canal treatment in adults with chronic apical abscess. The main questions it aims to answer are:
- How does the root canal bacterial profile change before and after irrigation with 5.25 percent sodium hypochlorite or 3 percent sodium hypochlorite?
- How does the bacterial profile change after calcium hydroxide medicament is placed in the root canal?
Participants will:
- Receive standard root canal treatment with one of two irrigation regimens (5.25 percent or 3 percent sodium hypochlorite, plus EDTA),
- Have root canal samples taken three times (before any treatment, after irrigation, and after calcium hydroxide medicament), and
- Have the bacteria in these samples analyzed using 16S rRNA PCR and DNA sequencing.
Detailed description
Chronic apical abscess is associated with complex multispecies biofilms in the root canal that can differ between populations and are not fully characterized by conventional culture methods. This study focuses on adult patients with necrotic molar teeth and chronic apical abscess treated at the Dental and Oral Hospital, Faculty of Dentistry, Hasanuddin University. The main objective is to describe how the root canal bacterial community profile changes during different phases of routine root canal treatment using 16S rRNA PCR and sequence analysis.
The study uses a descriptive and analytic repeated-measures design. At least 24 adult outpatients with necrotic pulp and chronic apical abscess who meet the inclusion and exclusion criteria will be recruited and provide written informed consent. After rubber dam isolation, access cavity preparation, and working length determination, the first root canal sample (S1) is collected from the distal canal using a sterile Hedström file and transferred into a tube containing DNA preservative solution. Mechanical preparation is then performed with rotary instruments. Patients are randomly assigned by clinic staff, who are blinded to the investigator, to one of two irrigation regimens: 5.25 percent sodium hypochlorite or 3 percent sodium hypochlorite, each followed by sterile distilled water, 17 percent EDTA, and a final rinse with sterile distilled water. A second sample (S2) is collected from the same canal after irrigation. Calcium hydroxide intracanal medicament is then placed and the tooth is temporized.
After approximately two weeks, the temporary restoration and calcium hydroxide are removed, and a third sample (S3) is collected from the same canal using a sterile Hedström file. All samples are stored in DNA preservative solution and analyzed by 16S rRNA PCR followed by DNA sequencing to characterize the bacterial community composition and diversity. The study will compare bacterial taxa and community profiles at S1, S2, and S3 and between the two sodium hypochlorite concentrations in order to explore how root canal irrigation and calcium hydroxide medicament are associated with changes in the bacterial community.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel groups of adults with chronic apical abscess receive standard root canal treatment with different sodium hypochlorite irrigation concentrations (5.25 percent or 3 percent). Root canal samples are collected three times from the same canal to compare changes in the bacterial community profile over time.
| Arm | Type | Receives |
|---|---|---|
| 5.25% sodium hypochlorite Irrigation | Experimental | Procedure: Root canal treatment with 5.25% sodium hypochlorite irrigationParticipants received standard root canal treatment for molar teeth with chronic apical abscess using irrigation with 5.25 percent sodium hypochlorite. The procedure includes mechanical preparation, rinsing with sterile distilled water and 17 percent EDTA, placement of calcium hydroxide intracanal medicament, and final obturation. Root canal samples are collected from the same canal before treatment, after irrigation, and after calcium hydroxide medicament. |
| 3% sodium hypochloritel Irrigation | Experimental | Procedure: Root canal treatment with 3% sodium hypochlorite irrigationParticipants received standard root canal treatment for molar teeth with chronic apical abscess using irrigation with 3 percent sodium hypochlorite. The procedure includes mechanical preparation, rinsing with sterile distilled water and 17 percent EDTA, placement of calcium hydroxide intracanal medicament, and final obturation. Root canal samples are collected from the same canal before treatment, after irrigation, and after calcium hydroxide medicament. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult aged between 18 and 75 years.
- Physically and mentally able to undergo treatment
- Have not used antibiotics within 1 week before treatment.
- Permanent molar teeth showing clinical and radiographic signs of chronic apical abscess and considered restorable.
- Willing to participate in the study and able to provide written informed consent after receiving an explanation of the study.
Key exclusion criteria (9 listed)
- Systemic conditions that require antibiotic prophylaxis for routine dental treatment or other significant systemic disease.
- Pregnant or breastfeeding women.
- Participants with cognitive impairment.
- Teeth with advanced mobility (greater than grade 2).
- Teeth with periodontal pockets deeper than 4 mm.
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 |
|---|---|---|
| Root canal treatment with 5.25% sodium hypochlorite irrigationStandard root canal procedure in which the canal is irrigated with 5.25 percent sodium hypochlorite, followed by sterile distilled water and 17 percent EDTA, then calcium hydroxide intracanal medicament and final obturation, with bacterial sampling at three time points. | Procedure or surgery | 5.25% sodium hypochlorite Irrigation |
| Root canal treatment with 3% sodium hypochlorite irrigationStandard root canal procedure in which the canal is irrigated with 3 percent sodium hypochlorite, followed by sterile distilled water and 17 percent EDTA, then calcium hydroxide intracanal medicament and final obturation, with bacterial sampling at three time points. | Procedure or surgery | 3% sodium hypochloritel Irrigation |
Primary outcome
Change in root canal bacterial community profile
Time frame: Baseline/S1 (before any treatment), immediately after irrigation (S2), and approximately 2 weeks after calcium hydroxide medicament (S3).
Bacterial community composition and diversity in root canal samples from molar teeth with chronic apical abscess, assessed using 16S rRNA PCR and DNA sequencing at three time points (before treatment, after irrigation, and after calcium hydroxide medicament).
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 5 Jun 2026.
- BackgroundWang, X., et al. (2023). Longitudinal Analysis of Root Canal Microbiome Using 16S rRNA Sequencing. Journal of Endodontics.
- 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of privacy considerations and institutional and ethics committee policies that restrict sharing of identifiable clinical data outside the study team.
Related trials for Chronic Apical Abscess
Not yet recruiting
Using Platelet-rich Fibrin in Regenerative Endodontic Treatment in Mature Permanent Teeth
Chronic Apical Periodontitis, Necrosis of Pulp
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.
Beatrix Zitzy Uniquen Enoch, DDS principal investigator
Dental and Oral Hospital Hasanuddin University
Prof. Maria Tanumihardja, DDS, MDS study director
Dental and Oral Hospital Hasanuddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Root canal treatment with 5.25% sodium hypochlorite irrigation and Root canal treatment with 3% sodium hypochlorite irrigation in people with Chronic Apical Abscess 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 5 inclusion and 9 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 5 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?
Change in root canal bacterial community profile (time frame: Baseline/S1 (before any treatment), immediately after irrigation (S2), and approximately 2 weeks after calcium hydroxide medicament (S3).). 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 NCT07623278, 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 5 Jun 2026.