Antibacterial Efficacy of Bioceramic and Calcium Hydroxide Intracanal Medicaments

NCT07671326 | Recruiting DMC

• 1 other identifier: 10840098-202.3.02-2258
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periapical Periodontitis; Root Canal Infection; Intracanal Medicaments

Keywords

intracanal medicament; bioceramic medicament; ultrasonic activation; ddPCR

Outcome Measures

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.

  From baseline microbiological sampling during the first appointment to post-medication and final irrigation sampling at the second appointment.

Study Arms (2)

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.

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.

Procedure: Root canal treatment with UltraCal XS, a calcium hydroxide-based intracanal medicament

Interventions

Root canal treatment with Bio-C Temp, a calcium silicate-based bioceramic intracanal medicament PROCEDURE

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.

Bio-C Temp, a Calcium Silicate-Based Bioceramic Intracanal Medicament

Root canal treatment with UltraCal XS, a calcium hydroxide-based intracanal medicament PROCEDURE

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.

UltraCal XS, a Calcium Hydroxide-Based Intracanal Medicament

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Istanbul, 34230, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

UltraCal XS

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: October 15, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After its publication in a journal, we want to share our data.

Locations

TU (1)