Asymptomatic Apical PeriodontitisNCT07915401
Bacterial Reduction in Apical Root Canals After Bioceramic or Calcium Hydroxide Medicament
A study testing Bio-C Temp and Calcium hydroxide medicament in people with Asymptomatic Apical Periodontitis, run by Hasanuddin University at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to learn whether a bioceramic root canal medicament reduces bacteria better than calcium hydroxide in adults with asymptomatic apical periodontitis (a long-standing infection at the tip of the tooth root that does not cause pain) in upper front teeth. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asymptomatic Apical Periodontitis
- What is being tested?
- Bio-C Temp and Calcium hydroxide medicament
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndonesia
- Study dates
- 12 Jun 2026to 28 Sep 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years or older who are physically and mentally healthy
- Willing to sign written informed consent
- Permanent single-rooted maxillary anterior tooth diagnosed with asymptomatic apical periodontitis, confirmed by:
- No history of spontaneous pain or pain on biting
- Negative pulp vitality test
- Negative percussion and palpation tests
- Periapical radiolucency with Periapical Index (PAI) score of 3 or higher
Who cannot join
- Tooth mobility greater than grade 2
- Periodontal pocket depth greater than 4 mm
- Previous endodontic treatment on the tooth
- Crown or root fracture
- Internal or external root resorption
- Open apex
Show all 10Show fewer
- Calcified or obliterated root canal
- Antibiotic use within one week before treatment
- Pregnancy
- Systemically compromised conditions requiring antibiotic prophylaxis for routine dental treatment, or systemic disease
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Hasanuddin University Dental Hospital (Rumah Sakit Gigi Dan Mulut Pendidikan Universitas Hasanuddin)
Makassar, South Sulawesi, 90153
About this study
Official title: Comparison of Bacterial Load in the Apical Third of Root Canals With Asymptomatic Apical Periodontitis Following Bioceramic and Calcium Hydroxide Medicament Using Quantitative Polymerase Chain Reaction (qPCR)
The goal of this clinical trial is to learn whether a bioceramic root canal medicament reduces bacteria better than calcium hydroxide in adults with asymptomatic apical periodontitis (a long-standing infection at the tip of the tooth root that does not cause pain) in upper front teeth.
The main question it aims to answer is:
Read more
Does the bioceramic medicament (Bio-C Temp) lower the amount of bacteria in the end portion (apical third) of the root canal more than calcium hydroxide (UltraCal XS)?
Researchers will compare the bioceramic medicament with calcium hydroxide to see which one leaves fewer bacteria in the root canal after 14 days.
Participants will:
Receive standard root canal cleaning and shaping on one upper front tooth Have bacterial samples taken from the root canal before and after cleaning Be randomly assigned to receive either the bioceramic or the calcium hydroxide medicament inside the root canal for 14 days Return after 14 days for a final bacterial sample before the root canal treatment is continued
The amount of bacteria in each sample will be measured in the laboratory using quantitative polymerase chain reaction (qPCR).
Read the detailed description
This randomized controlled trial with two parallel groups was conducted at the Hasanuddin University Dental Hospital and the Hasanuddin University Medical Research Center (HUMRC) Laboratory, Makassar, Indonesia, from June to September 2026.
A total of 24 adult patients (18 years or older), each contributing one single-rooted maxillary anterior tooth diagnosed with asymptomatic apical periodontitis (negative pulp vitality, negative percussion and palpation tests, and Periapical Index [PAI] score ≥ 3), were recruited by purposive sampling. Participants were allocated to two groups (12 teeth per group) by computer-generated simple randomization using sealed envelopes.
Group 1 (intervention): chemomechanical preparation with ProTaper Gold, irrigation with 2.5% NaOCl activated by passive ultrasonic irrigation, followed by bioceramic intracanal medicament (Bio-C Temp, Angelus) for 14 days.
Group 2 (active comparator): the same preparation and irrigation protocol, followed by calcium hydroxide intracanal medicament (UltraCal XS, Ultradent) for 14 days.
Microbiological samples were collected from the apical third of the root canal using sterile K-files at three time points: before root canal preparation (S1), after preparation, irrigation and ultrasonic activation (S2), and after 14 days of intracanal medication (S3). The apical portion of each file was cut and stored in DNA/RNA Shield. Bacterial load was quantified using qPCR and compared within and between groups.
- Conditions
- Asymptomatic Apical Periodontitis
- Being tested
- Bio-C Temp, Calcium hydroxide medicament
- Keywords
- Intracanal Medicament, Bioceramic, Calcium Hydroxide, Bio-C Temp, UltraCal XS, qPCR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-C TempDevice
Also called Calcium Hydroxide, UltraCal XS
A ready-to-use, premixed bioceramic (calcium silicate-based) intracanal medicament (Bio-C Temp, Angelus). After chemomechanical preparation with ProTaper Gold files and 2.5% NaOCl irrigation activated by passive ultrasonic irrigation, the medicament was delivered into the root canal to the working length using the manufacturer's syringe and tip. The canal access was sealed with a sterile cotton pellet and temporary restoration, and the medicament was left in place for 14 days. At the second visit, the medicament was removed with sterile distilled water and the master apical file before final bacterial sampling (S3).
Calcium hydroxide medicamentDevice
Also called UltraCal XS
A premixed aqueous calcium hydroxide paste intracanal medicament (UltraCal XS, Ultradent). After chemomechanical preparation with ProTaper Gold files and 2.5% NaOCl irrigation activated by passive ultrasonic irrigation, the medicament was delivered into the root canal to the working length using the manufacturer's syringe and tip. The canal access was sealed with a sterile cotton pellet and temporary restoration, and the medicament was left in place for 14 days. At the second visit, the medicament was removed with sterile distilled water and the master apical file before final bacterial sampling (S3).
| Study group | Role | What they receive |
|---|---|---|
| Bioceramic Medicament | Experimental | Participants with asymptomatic apical periodontitis in a single-rooted maxillary anterior tooth received root canal preparation with ProTaper Gold rotary files and 2.5% NaOCl irrigation activated by passive ultrasonic irrigation. A bioceramic intracanal medicament (Bio-C Temp, Angelus) was then placed into the root canal and sealed with a temporary restoration for 14 days. Bacterial samples were collected from the apical third of the root canal before preparation (S1), after preparation and ultrasonic activation (S2), and after 14 days of medication (S3). Receives: Device: Bio-C Temp |
| Calcium Hydroxide Medicament | Active comparator | Participants with asymptomatic apical periodontitis in a single-rooted maxillary anterior tooth received root canal preparation with ProTaper Gold rotary files and 2.5% NaOCl irrigation activated by passive ultrasonic irrigation. A calcium hydroxide intracanal medicament (UltraCal XS, Ultradent) was then placed into the root canal and sealed with a temporary restoration for 14 days. Bacterial samples were collected from the apical third of the root canal before preparation (S1), after preparation and ultrasonic activation (S2), and after 14 days of medication (S3). Receives: Device: Calcium hydroxide medicament |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial Load in the Apical Third of the Root Canal
Total bacterial load in samples collected from the apical third of the root canal using sterile K-files, quantified by quantitative polymerase chain reaction (qPCR). Bacterial load was compared between the bioceramic (Bio-C Temp) and calcium hydroxide (UltraCal XS) groups after 14 days of intracanal medication (S3), and the reduction in bacterial load from S2 to S3 was calculated for each group. Results are expressed as log10-transformed calculated concentration (log10 Calc. Conc)
Measured: Baseline before root canal preparation (S1, Day 0), after preparation and ultrasonic activation (S2, Day 0), and after 14 days of intracanal medication (S3, Day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start12 Jun 2026
- Primary completion28 Sep 2026
- Study completion28 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic Apical PeriodontitisStudies 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 allocated in a 1:1 ratio to one of two parallel groups: a bioceramic intracanal medicament group (Bio-C Temp, Angelus) or a calcium hydroxide intracanal medicament group (UltraCal XS, Ultradent), with 12 participants per group. Each participant contributed one single-rooted maxillary anterior tooth. Bacterial samples were collected from the apical third of the root canal at three time points (S1, S2, and S3)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafikah Dwi Angraeni, Hasanuddin University
- Investigators
- Rafikah D Angraeni, drg, Principal investigator, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915401
- Sponsor's protocol ID
- 065/FKGUH/PPDGS_Kons-008/31.II
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the publication will be shared, including group allocation, tooth type, and bacterial load values (log10 Calc. Conc) measured by qPCR at the three sampling points (S1, S2, and S3). No personal identifying information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bacterial Load in the Apical Third of Root Canals With Asymptomatic Apical Periodontitis Following Bioceramic and Calcium Hydroxide Medicament Using Quantitative Polymerase Chain Reaction (qPCR)
- ClinicalTrials.gov ID
- NCT07915401
- Acronym / sponsor ID
- 065/FKGUH/PPDGS_Kons-008/31.II
- Conditions
- Asymptomatic Apical Periodontitis
- Keywords
- Intracanal Medicament, Bioceramic, Calcium Hydroxide, Bio-C Temp, UltraCal XS, qPCR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 28 Sep 2026 (actual)
- Study completion
- 28 Sep 2026 (actual)
- First posted
- 4 Nov 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 whether a bioceramic root canal medicament reduces bacteria better than calcium hydroxide in adults with asymptomatic apical periodontitis (a long-standing infection at the tip of the tooth root that does not cause pain) in upper front teeth.
The main question it aims to answer is:
Does the bioceramic medicament (Bio-C Temp) lower the amount of bacteria in the end portion (apical third) of the root canal more than calcium hydroxide (UltraCal XS)?
Researchers will compare the bioceramic medicament with calcium hydroxide to see which one leaves fewer bacteria in the root canal after 14 days.
Participants will:
Receive standard root canal cleaning and shaping on one upper front tooth Have bacterial samples taken from the root canal before and after cleaning Be randomly assigned to receive either the bioceramic or the calcium hydroxide medicament inside the root canal for 14 days Return after 14 days for a final bacterial sample before the root canal treatment is continued
The amount of bacteria in each sample will be measured in the laboratory using quantitative polymerase chain reaction (qPCR).
Detailed description
This randomized controlled trial with two parallel groups was conducted at the Hasanuddin University Dental Hospital and the Hasanuddin University Medical Research Center (HUMRC) Laboratory, Makassar, Indonesia, from June to September 2026.
A total of 24 adult patients (18 years or older), each contributing one single-rooted maxillary anterior tooth diagnosed with asymptomatic apical periodontitis (negative pulp vitality, negative percussion and palpation tests, and Periapical Index [PAI] score ≥ 3), were recruited by purposive sampling. Participants were allocated to two groups (12 teeth per group) by computer-generated simple randomization using sealed envelopes.
Group 1 (intervention): chemomechanical preparation with ProTaper Gold, irrigation with 2.5% NaOCl activated by passive ultrasonic irrigation, followed by bioceramic intracanal medicament (Bio-C Temp, Angelus) for 14 days.
Group 2 (active comparator): the same preparation and irrigation protocol, followed by calcium hydroxide intracanal medicament (UltraCal XS, Ultradent) for 14 days.
Microbiological samples were collected from the apical third of the root canal using sterile K-files at three time points: before root canal preparation (S1), after preparation, irrigation and ultrasonic activation (S2), and after 14 days of intracanal medication (S3). The apical portion of each file was cut and stored in DNA/RNA Shield. Bacterial load was quantified using qPCR and compared within and between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly allocated in a 1:1 ratio to one of two parallel groups: a bioceramic intracanal medicament group (Bio-C Temp, Angelus) or a calcium hydroxide intracanal medicament group (UltraCal XS, Ultradent), with 12 participants per group. Each participant contributed one single-rooted maxillary anterior tooth. Bacterial samples were collected from the apical third of the root canal at three time points (S1, S2, and S3)
| Arm | Type | Receives |
|---|---|---|
| Bioceramic Medicament | Experimental | Device: Bio-C TempParticipants with asymptomatic apical periodontitis in a single-rooted maxillary anterior tooth received root canal preparation with ProTaper Gold rotary files and 2.5% NaOCl irrigation activated by passive ultrasonic irrigation. A bioceramic intracanal medicament (Bio-C Temp, Angelus) was then placed into the root canal and sealed with a temporary restoration for 14 days. Bacterial samples were collected from the apical third of the root canal before preparation (S1), after preparation and ultrasonic activation (S2), and after 14 days of medication (S3). |
| Calcium Hydroxide Medicament | Active comparator | Device: Calcium hydroxide medicamentParticipants with asymptomatic apical periodontitis in a single-rooted maxillary anterior tooth received root canal preparation with ProTaper Gold rotary files and 2.5% NaOCl irrigation activated by passive ultrasonic irrigation. A calcium hydroxide intracanal medicament (UltraCal XS, Ultradent) was then placed into the root canal and sealed with a temporary restoration for 14 days. Bacterial samples were collected from the apical third of the root canal before preparation (S1), after preparation and ultrasonic activation (S2), and after 14 days of medication (S3). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients aged 18 years or older who are physically and mentally healthy
- Willing to sign written informed consent
- Permanent single-rooted maxillary anterior tooth diagnosed with asymptomatic apical periodontitis, confirmed by:
- No history of spontaneous pain or pain on biting
- Negative pulp vitality test
Key exclusion criteria (10 listed)
- Tooth mobility greater than grade 2
- Periodontal pocket depth greater than 4 mm
- Previous endodontic treatment on the tooth
- Crown or root fracture
- Internal or external root resorption
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 |
|---|---|---|
| Bio-C TempAlso: Calcium Hydroxide, UltraCal XSA ready-to-use, premixed bioceramic (calcium silicate-based) intracanal medicament (Bio-C Temp, Angelus). After chemomechanical preparation with ProTaper Gold files and 2.5% NaOCl irrigation activated by passive ultrasonic irrigation, the medicament was delivered into the root canal to the working length using the manufacturer's syringe and tip. The canal access was sealed with a sterile cotton pellet and temporary restoration, and the medicament was left in place for 14 days. At the second visit, the medicament was removed with sterile distilled water and the master apical file before final bacterial sampling (S3). | Device | Bioceramic Medicament |
| Calcium hydroxide medicamentAlso: UltraCal XSA premixed aqueous calcium hydroxide paste intracanal medicament (UltraCal XS, Ultradent). After chemomechanical preparation with ProTaper Gold files and 2.5% NaOCl irrigation activated by passive ultrasonic irrigation, the medicament was delivered into the root canal to the working length using the manufacturer's syringe and tip. The canal access was sealed with a sterile cotton pellet and temporary restoration, and the medicament was left in place for 14 days. At the second visit, the medicament was removed with sterile distilled water and the master apical file before final bacterial sampling (S3). | Device | Calcium Hydroxide Medicament |
Primary outcome
Bacterial Load in the Apical Third of the Root Canal
Time frame: Baseline before root canal preparation (S1, Day 0), after preparation and ultrasonic activation (S2, Day 0), and after 14 days of intracanal medication (S3, Day 14)
Total bacterial load in samples collected from the apical third of the root canal using sterile K-files, quantified by quantitative polymerase chain reaction (qPCR). Bacterial load was compared between the bioceramic (Bio-C Temp) and calcium hydroxide (UltraCal XS) groups after 14 days of intracanal medication (S3), and the reduction in bacterial load from S2 to S3 was calculated for each group. Results are expressed as log10-transformed calculated concentration (log10 Calc. Conc)
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 4 Nov 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the publication will be shared, including group allocation, tooth type, and bacterial load values (log10 Calc. Conc) measured by qPCR at the three sampling points (S1, S2, and S3). No personal identifying information will be shared.
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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.
Rafikah D Angraeni, drg principal investigator
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 Bio-C Temp and Calcium hydroxide medicament in people with Asymptomatic Apical Periodontitis, 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 7 inclusion and 10 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 4 Nov 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?
Bacterial Load in the Apical Third of the Root Canal (time frame: Baseline before root canal preparation (S1, Day 0), after preparation and ultrasonic activation (S2, Day 0), and after 14 days of intracanal medication (S3, Day 14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.