Antibacterial Efficacy of Bioceramic and Calcium Hydroxide Intracanal Medicaments
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMedipol University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Root canal treatment with Bio-C Temp, a calcium silicate-based bioceramic intracanal medicament
Procedure/SurgeryParticipants 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 medicament
Procedure/SurgeryParticipants 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Bio-C Temp, a Calcium Silicate-Based Bioceramic Intracanal MedicamentExperimental treatment 1 intervention
Group B: UltraCal XS, a Calcium Hydroxide-Based Intracanal MedicamentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From baseline microbiological sampling during the first appointment to post-medication and final irrigation sampling at the second appointment.Sponsors and contacts
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Source ClinicalTrials.gov