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Antibacterial Efficacy of Bioceramic and Calcium Hydroxide Intracanal Medicaments

25. juni 2026 opdateret af: Berke Turgut, Medipol University

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Bio-C Temp, a Calcium Silicate-Based Bioceramic Intracanal Medicament
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.
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.
Aktiv komparator: UltraCal XS, a Calcium Hydroxide-Based Intracanal Medicament
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.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reduction in Intracanal Bacterial Load
Tidsramme: 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.
From baseline microbiological sampling during the first appointment to post-medication and final irrigation sampling at the second appointment.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. oktober 2025

Primær færdiggørelse (Anslået)

1. september 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

22. juni 2026

Først indsendt, der opfyldte QC-kriterier

22. juni 2026

Først opslået (Faktiske)

26. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

After its publication in a journal, we want to share our data.

IPD-delingstidsramme

After its publication in a journal, we want to share our data.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

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