Antibacterial Efficacy of Bioceramic and Calcium Hydroxide Intracanal Medicaments

NCT07671326 · tracked via the Priya Life Science Turkey tracker

Sponsor

Medipol University

Phase

Not applicable

Started

2025-10-15

Last updated

2026-06-29

Condition(s) studied

Periapical PeriodontitisRoot Canal InfectionIntracanal Medicaments

Investigational drug(s) / intervention(s)

Root canal treatment with Bio-C Temp, a calcium silicate-based bioceramic intracanal medicamentRoot canal treatment with UltraCal XS, a calcium hydroxide-based intracanal medicament

Root canal treatment with Bio-C Temp, a calcium silicate-based bioceramic intracanal medicament: 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 medicament: 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 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. Intracanal bacterial load is assessed before and after root canal preparation, after intracanal medicament removal, and after final irrigation using droplet digital PCR.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Accepted

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Reduction in Intracanal Bacterial Load — 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.

Trial sites (1)

Facility	City	Region	Status
Istanbul Medipol University	Istanbul	Istanbul	Recruiting

More Medipol University trials in Turkey

Comparison of QLB and TFP Block for Postoperative Analgesia in Laparoscopic Inguinal Hernia Starting soon

Compassion, Social Support, Flexibility, and Resilience Program for Women Surviving Breast Cancer Enrolling by invitation

A New Tool for Extubation Readiness in Mechanically Ventilated Patients: Readiness for EXtubation Score Recruiting

One-Year Outcomes After Conversion Bariatric Surgery Active, not recruiting

Investigation of the Effectiveness of Cervicothoracic Exercises in Individuals With Carpal Tunnel Syndrome Recruiting

Other trials for the same condition

Toluidine Blue-Based Photodynamic Therapy for Antibacterial Activity and Postoperative Pain Active, not recruiting

Lesion Sterilization Tissue Repair and Conventional Pulpectomy in Primary Molars Active, not recruiting

Chitosan Irrigation in Premolar Root Canal Therapy (Randomized Trial) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07671326 on ClinicalTrials.gov ↗ ← All trials in Turkey