An interventional study of Bio-C Temp and Calcium hydroxide medicament in Asymptomatic Apical Periodontitis, sponsored by Hasanuddin University. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Hasanuddin University · Not applicable, Interventional, and Treatment
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).
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.
280 studies on the registry are indexed under Periapical Periodontitis; 79 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 245 interventional studies indexed under Periapical Periodontitis.
Browse Periapical Periodontitis studies →Hasanuddin University is the lead sponsor of 69 studies on the registry; 6 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Device: Bio-C Temp
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).
Device: Calcium hydroxide medicament
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).
Also known as: Calcium Hydroxide, 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).
Also known as: UltraCal XS
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)
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)
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data and supporting information will be available beginning 3 months after publication of the study results and ending 5 years after pu
Access criteria: Data will be shared with qualified researchers who provide a methodologically sound proposal for scientific purposes. Requests should be sent by email to the principal investigator. Data will be provided after approval of the proposal and signing of a data use agreement.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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