Periapical PeriodontitisNCT07671326
Antibacterial Efficacy of Bioceramic and Calcium Hydroxide Intracanal Medicaments
A study testing Root canal treatment with Bio-C Temp, a calcium silicate-based bioceramic intracanal medicament and Root canal treatment with UltraCal XS, a calcium hydroxide-based intracanal medicament in people with Periapical Periodontitis and Root Canal Infection, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the antibacterial effectiveness of two different intracanal medicaments, Bio-C Temp and UltraCal XS , in mandibular molar teeth with chronic apical periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Periodontitis, Root Canal Infection, Intracanal Medicaments
- What is being tested?
- Root canal treatment with Bio-C Temp, a calcium silicate-based bioceramic intracanal medicament and Root canal treatment with UltraCal XS, a calcium hydroxide-based intracanal medicament
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 65 years
- Being systemically healthy (ASA I or ASA II)
- Mandibular molar teeth with a radiographically detectable radiolucent lesion in the periapical region
- Willingness of the volunteer or their legal representative to participate in the study by signing the Informed Consent Form
Who cannot join
- Patients who have received antibiotics or corticosteroids within the last 3 months
- Patients with systemic diseases
- Teeth that cannot be properly isolated with a rubber dam
- Teeth with periodontal pockets >4 mm and teeth with crown/root fractures
- Individuals who are undergoing or planning to start orthodontic treatment during the study period
- Pregnant or breastfeeding individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medipol University
Istanbul, Istanbul, 34230
Berke Turgut, +905312267156, dtberketurgut@gmail.com
Tan Fırat Eyüboğlu, +905304636059, tfeyuboglu@yahoo.com
About this study
Official title: Antibacterial Efficacy of Bioceramic and Calcium Hydroxide-Based Intracanal Medicaments in Endodontic Treatment
This study evaluates the antibacterial effectiveness of two different intracanal medicaments, Bio-C Temp and UltraCal XS , in mandibular molar teeth with chronic apical periodontitis. Intracanal bacterial load is assessed before and after root canal preparation, after intracanal medicament removal, and after final irrigation using droplet digital PCR.
Read the detailed description
This randomized controlled clinical trial investigates the effect of two different intracanal medicaments on the reduction of intracanal bacterial load in mandibular molar teeth diagnosed with chronic apical periodontitis. The study is conducted at Istanbul Medipol University Faculty of Dentistry, Department of Endodontics, and includes systemically healthy participants aged 18-65 years who require primary root canal treatment and present with radiographic evidence of periapical radiolucency.
Participants are randomly assigned to two groups. In the first group, Bio-C Temp is used as the intracanal medicament. In the second group, a UltraCal XS is applied. All teeth are isolated with a rubber dam, and the operative field is disinfected before access cavity preparation. After removal of previous restorations and caries, sterility control samples are collected from the tooth surface.
Working length is determined using an electronic apex locator and confirmed radiographically. Initial microbiological samples are collected from the root canals using sterile paper points. Root canal shaping is performed with heat-treated nickel-titanium rotary files, and canal enlargement is completed with a VDW Rotate #35/.04 file. The irrigation protocol includes 2.5% sodium hypochlorite and 17% EDTA, followed by passive ultrasonic irrigation using an IRRI S ultrasonic tip. Sodium hypochlorite is inactivated with 10% sodium thiosulfate before microbiological sampling.
After chemomechanical preparation, the assigned intracanal medicament is placed 1-2 mm short of the working length, and the access cavity is temporarily sealed. Participants are recalled after 14 days. At the second appointment, the intracanal medicament is removed mechanically and chemically. A neutralization step is performed before further sampling, and the final irrigation and ultrasonic activation protocol is repeated.
Bacterial samples are collected at different stages of treatment, including baseline, after chemomechanical preparation, after medicament removal, and after final irrigation. The bacterial load is quantified using droplet digital PCR, a sensitive molecular method that allows absolute quantification of bacterial DNA. This technique is used to compare the antibacterial effect of Bio-C Temp and calcium hydroxide and to evaluate bacterial reduction throughout the treatment protocol.
Pain levels are also recorded using a visual analog scale. After completion of the sampling and irrigation procedures, the root canals are obturated with gutta-percha using the lateral condensation technique, and the access cavities are restored with composite resin. A final periapical radiograph is taken for treatment control.
- Being tested
- Root canal treatment with Bio-C Temp, a calcium silicate-based bioceramic intracanal medicament, Root canal treatment with UltraCal XS, a calcium hydroxide-based intracanal medicament
- Keywords
- intracanal medicament, bioceramic medicament, ultrasonic activation, ddPCR
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal treatment with Bio-C Temp, a calcium silicate-based bioceramic intracanal medicamentProcedure or surgery
Participants in this group undergo root canal shaping using VDW Rotate heat-treated nickel-titanium rotary files, and root canal preparation is completed up to #35/.04. The irrigation protocol includes 2.5% sodium hypochlorite (NaOCl) and 17% EDTA, followed by passive ultrasonic irrigation (PUI) using a VDW Ultra device with an IRRI S 21/25 ultrasonic tip. After chemomechanical preparation and microbiological sampling, Bio-C Temp, a calcium silicate-based bioceramic intracanal medicament, is placed into the root canals 1-2 mm short of the working length. The access cavity is temporarily sealed, and the medicament is left in place for 14 days.
Root canal treatment with UltraCal XS, a calcium hydroxide-based intracanal medicamentProcedure or surgery
Participants in this group undergo the same standardized root canal shaping and irrigation protocol as the Bio-C Temp group. Root canal shaping is performed using VDW Rotate heat-treated nickel-titanium rotary files and completed up to #35/.04. The irrigation protocol includes 2.5% sodium hypochlorite (NaOCl), 17% EDTA, and passive ultrasonic irrigation (PUI) with a VDW Ultra device and an IRRI S 21/25 ultrasonic tip. After chemomechanical preparation and microbiological sampling, UltraCal XS, a calcium hydroxide-based intracanal medicament, is placed into the root canals 1-2 mm short of the working length. The access cavity is temporarily sealed, and the medicament is left in place for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Bio-C Temp, a Calcium Silicate-Based Bioceramic Intracanal Medicament | Experimental | Intervention: Participants in this group receive Bio-C Temp, a calcium silicate-based bioceramic intracanal medicament, after standardized chemomechanical root canal preparation and passive ultrasonic irrigation. The medicament is placed into the root canals 1-2 mm short of the working length, and the access cavity is temporarily sealed for 14 days. Receives: Procedure: Root canal treatment with Bio-C Temp, a calcium silicate-based bioceramic intracanal medicament |
| UltraCal XS, a Calcium Hydroxide-Based Intracanal Medicament | Active comparator | Intervention: Participants in this group receive UltraCal XS, a calcium hydroxide-based intracanal medicament, after the same standardized chemomechanical root canal preparation and passive ultrasonic irrigation protocol. The medicament is placed into the root canals 1-2 mm short of the working length, and the access cavity is temporarily sealed for 14 days. Receives: Procedure: Root canal treatment with UltraCal XS, a calcium hydroxide-based intracanal medicament |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Intracanal Bacterial Load
Quantitative reduction in intracanal bacterial load in mandibular molar teeth with chronic apical periodontitis, as measured by Droplet Digital PCR (ddPCR), following standardized chemomechanical root canal preparation, passive ultrasonic irrigation, and the application of two different intracanal medicaments. Bacterial samples are collected at predetermined stages of treatment to compare the antibacterial effectiveness of Bio-C Temp, a calcium silicate-based bioceramic intracanal medicament, and UltraCal XS, a calcium hydroxide-based intracanal medicament.
Measured: From baseline microbiological sampling during the first appointment to post-medication and final irrigation sampling at the second appointment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start15 Oct 2025
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berke Turgut, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671326
- Sponsor's protocol ID
- 10840098-202.3.02-2258
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After its publication in a journal, we want to share our data.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibacterial Efficacy of Bioceramic and Calcium Hydroxide-Based Intracanal Medicaments in Endodontic Treatment
- ClinicalTrials.gov ID
- NCT07671326
- Acronym / sponsor ID
- 10840098-202.3.02-2258
- Keywords
- intracanal medicament, bioceramic medicament, ultrasonic activation, ddPCR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 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.
This study evaluates the antibacterial effectiveness of two different intracanal medicaments, Bio-C Temp and UltraCal XS , in mandibular molar teeth with chronic apical periodontitis. Intracanal bacterial load is assessed before and after root canal preparation, after intracanal medicament removal, and after final irrigation using droplet digital PCR.
Detailed description
This randomized controlled clinical trial investigates the effect of two different intracanal medicaments on the reduction of intracanal bacterial load in mandibular molar teeth diagnosed with chronic apical periodontitis. The study is conducted at Istanbul Medipol University Faculty of Dentistry, Department of Endodontics, and includes systemically healthy participants aged 18-65 years who require primary root canal treatment and present with radiographic evidence of periapical radiolucency.
Participants are randomly assigned to two groups. In the first group, Bio-C Temp is used as the intracanal medicament. In the second group, a UltraCal XS is applied. All teeth are isolated with a rubber dam, and the operative field is disinfected before access cavity preparation. After removal of previous restorations and caries, sterility control samples are collected from the tooth surface.
Working length is determined using an electronic apex locator and confirmed radiographically. Initial microbiological samples are collected from the root canals using sterile paper points. Root canal shaping is performed with heat-treated nickel-titanium rotary files, and canal enlargement is completed with a VDW Rotate #35/.04 file. The irrigation protocol includes 2.5% sodium hypochlorite and 17% EDTA, followed by passive ultrasonic irrigation using an IRRI S ultrasonic tip. Sodium hypochlorite is inactivated with 10% sodium thiosulfate before microbiological sampling.
After chemomechanical preparation, the assigned intracanal medicament is placed 1-2 mm short of the working length, and the access cavity is temporarily sealed. Participants are recalled after 14 days. At the second appointment, the intracanal medicament is removed mechanically and chemically. A neutralization step is performed before further sampling, and the final irrigation and ultrasonic activation protocol is repeated.
Bacterial samples are collected at different stages of treatment, including baseline, after chemomechanical preparation, after medicament removal, and after final irrigation. The bacterial load is quantified using droplet digital PCR, a sensitive molecular method that allows absolute quantification of bacterial DNA. This technique is used to compare the antibacterial effect of Bio-C Temp and calcium hydroxide and to evaluate bacterial reduction throughout the treatment protocol.
Pain levels are also recorded using a visual analog scale. After completion of the sampling and irrigation procedures, the root canals are obturated with gutta-percha using the lateral condensation technique, and the access cavities are restored with composite resin. A final periapical radiograph is taken for treatment control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bio-C Temp, a Calcium Silicate-Based Bioceramic Intracanal Medicament | Experimental | Procedure: Root canal treatment with Bio-C Temp, a calcium silicate-based bioceramic intracanal medicamentIntervention: Participants in this group receive Bio-C Temp, a calcium silicate-based bioceramic intracanal medicament, after standardized chemomechanical root canal preparation and passive ultrasonic irrigation. The medicament is placed into the root canals 1-2 mm short of the working length, and the access cavity is temporarily sealed for 14 days. |
| UltraCal XS, a Calcium Hydroxide-Based Intracanal Medicament | Active comparator | Procedure: Root canal treatment with UltraCal XS, a calcium hydroxide-based intracanal medicamentIntervention: Participants in this group receive UltraCal XS, a calcium hydroxide-based intracanal medicament, after the same standardized chemomechanical root canal preparation and passive ultrasonic irrigation protocol. The medicament is placed into the root canals 1-2 mm short of the working length, and the access cavity is temporarily sealed for 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged between 18 and 65 years
- Being systemically healthy (ASA I or ASA II)
- Mandibular molar teeth with a radiographically detectable radiolucent lesion in the periapical region
- Willingness of the volunteer or their legal representative to participate in the study by signing the Informed Consent Form
Key exclusion criteria (6 listed)
- Patients who have received antibiotics or corticosteroids within the last 3 months
- Patients with systemic diseases
- Teeth that cannot be properly isolated with a rubber dam
- Teeth with periodontal pockets >4 mm and teeth with crown/root fractures
- Individuals who are undergoing or planning to start orthodontic treatment during the study period
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 Bio-C Temp, a calcium silicate-based bioceramic intracanal medicamentParticipants in this group undergo root canal shaping using VDW Rotate heat-treated nickel-titanium rotary files, and root canal preparation is completed up to #35/.04. The irrigation protocol includes 2.5% sodium hypochlorite (NaOCl) and 17% EDTA, followed by passive ultrasonic irrigation (PUI) using a VDW Ultra device with an IRRI S 21/25 ultrasonic tip. After chemomechanical preparation and microbiological sampling, Bio-C Temp, a calcium silicate-based bioceramic intracanal medicament, is placed into the root canals 1-2 mm short of the working length. The access cavity is temporarily sealed, and the medicament is left in place for 14 days. | Procedure or surgery | Bio-C Temp, a Calcium Silicate-Based Bioceramic Intracanal Medicament |
| Root canal treatment with UltraCal XS, a calcium hydroxide-based intracanal medicamentParticipants in this group undergo the same standardized root canal shaping and irrigation protocol as the Bio-C Temp group. Root canal shaping is performed using VDW Rotate heat-treated nickel-titanium rotary files and completed up to #35/.04. The irrigation protocol includes 2.5% sodium hypochlorite (NaOCl), 17% EDTA, and passive ultrasonic irrigation (PUI) with a VDW Ultra device and an IRRI S 21/25 ultrasonic tip. After chemomechanical preparation and microbiological sampling, UltraCal XS, a calcium hydroxide-based intracanal medicament, is placed into the root canals 1-2 mm short of the working length. The access cavity is temporarily sealed, and the medicament is left in place for 14 days. | Procedure or surgery | UltraCal XS, a Calcium Hydroxide-Based Intracanal Medicament |
Primary outcome
Reduction in Intracanal Bacterial Load
Time frame: From baseline microbiological sampling during the first appointment to post-medication and final irrigation sampling at the second appointment.
Quantitative reduction in intracanal bacterial load in mandibular molar teeth with chronic apical periodontitis, as measured by Droplet Digital PCR (ddPCR), following standardized chemomechanical root canal preparation, passive ultrasonic irrigation, and the application of two different intracanal medicaments. Bacterial samples are collected at predetermined stages of treatment to compare the antibacterial effectiveness of Bio-C Temp, a calcium silicate-based bioceramic intracanal medicament, and UltraCal XS, a calcium hydroxide-based intracanal medicament.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Yes. After its publication in a journal, we want to share our 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.
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 Bio-C Temp, a calcium silicate-based bioceramic intracanal medicament and Root canal treatment with UltraCal XS, a calcium hydroxide-based intracanal medicament in people with Periapical Periodontitis and Root Canal Infection, run by Medipol University at 1 site in Turkey (Türkiye).
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 6 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: looking for participants now, as of the sponsor's last update on 29 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Intracanal Bacterial Load (time frame: From baseline microbiological sampling during the first appointment to post-medication and final irrigation sampling at the second appointment.). 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 29 Jun 2026.