- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07671326
Antibacterial Efficacy of Bioceramic and Calcium Hydroxide Intracanal Medicaments
Antibacterial Efficacy of Bioceramic and Calcium Hydroxide-Based Intracanal Medicaments in Endodontic Treatment
Studieoversikt
Status
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Istanbul
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Istanbul, Istanbul, Tyrkia (Türkiye), 34230
- Rekruttering
- Istanbul Medipol University
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Ta kontakt med:
- Berke Turgut
- Telefonnummer: +905312267156
- E-post: dtberketurgut@gmail.com
-
Ta kontakt med:
- Tan Fırat Eyüboğlu
- Telefonnummer: +905304636059
- E-post: tfeyuboglu@yahoo.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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.
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 10840098-202.3.02-2258
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
IPD-delingstidsramme
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
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