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Effect of Calcium Silicate-Based Root Canal Medicament After Retreatment

Evaluation of the Effect of Calcium Silicate-Based Root Canal Medicament on Antifungal-Antibacterial Activity and Post-Operative Pain After Retreatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06779370
Enrollment
60
Registered
2025-01-16
Start date
2024-06-12
Completion date
2025-01-10
Last updated
2025-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibacterial Agents, Antifungal Agents, Postoperative Dental Pain

Keywords

calcium silicate based root canal medicament, calcium hydroxide based root canal medicament, bacterial load, antibacterial effect, antifungal effect, postoperative pain

Brief summary

Calcium hydroxide is generally preferred in endodontics as an intracanal medicament due to its antimicrobial and biological effects. However, the antimicrobial effect of calcium hydroxide is limited. A new calcium silicate-based root canal medicament has been developed as an alternative to calcium hydroxide-based medicaments. The aim of this study was to investigate the effects of calcium silicate-based root canal medicament on antibacterial, antifungal activity, and postoperative pain in root canal-treated teeth with periapical lesions.

Detailed description

Sixty patients were randomly divided into two groups using a web-based program according to the selected medicament (calcium silicate-based root canal medicament or calcium hydroxide-based root canal medicament). After the removal of gutta-percha from the root canals, the first samples were collected using paper points to evaluate antibacterial and antifungal effects. The root canals were then chemomechanically prepared, followed by final irrigation activation, and the second samples were collected. The selected root canal medicament was placed in the canals, and the patients were given a form to record their postoperative pain levels over one week. At the second appointment, the medicaments were removed, and third samples were collected using paper points to assess antibacterial and antifungal effects. The root canal treatments of the patients were then completed. The antibacterial and antifungal effects of the medicaments were evaluated using PCR, and the patients' postoperative pain levels were recorded using follow-up forms.

Interventions

Root canal filling was removed with endodontic file. Sterile paper points were placed at working length to assess antibacterial and antifungal effects before the medicament was placed. Subsequently, the root canals were chemomechanically prepared, final irrigation activation was performed, and second samples were collected in the same manner. The calcium silicate-based root canal medicament was placed in the canals, and the teeth were sealed with temporary fillings. A form was provided to evaluate the patients' postoperative pain levels over one week. At the second appointment, the medicament was removed, and third samples were collected to assess antibacterial effects. The root canal treatments of the patients were completed. The antibacterial and antifungal effects of the medicaments were evaluated using PCR, and the patients' postoperative pain levels were recorded using follow-up forms.

DRUGCalcium hydroxide

Root canal filling was removed with endodontic file. Sterile paper points were placed at working length to assess antibacterial and antifungal effects before the medicament was placed. Subsequently, the root canals were chemomechanically prepared, final irrigation activation was performed, and second samples were collected in the same manner. The calcium hydroxide-based root canal medicament was placed in the canals, and the teeth were sealed with temporary fillings. A form was provided to evaluate the patients' postoperative pain levels over one week. At the second appointment, the medicament was removed, and third samples were collected to assess antibacterial effects. The root canal treatments of the patients were completed. The antibacterial and antifungal effects of the medicaments were evaluated using PCR, and the patients' postoperative pain levels were recorded using follow-up forms.

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

outcome assessments have performed by a investigator who was blinded to groups.

Intervention model description

two groups: group 1 calcium hydroxide based medicament (control group) group 2: calcium silicate based medicament

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy patients with aged between 18-60. * Incisor, canine, and premolar teeth that had previously undergone root canal treatment * Incisor, canine, and premolar teeth with a diagnosis of chronic apical abscess or asymptomatic apical periodontitis * teeth with only 1 root canal * the patients had not used any antibiotics for 3 months before treatment

Exclusion criteria

* the presence of a root fracture * teeth with any swelling * ankyloses, * periodontal pockets deeper than 4 mm. * teeth which a rubber dam could not be performed * patients with allergy to ibuprofen or ciprofloxacin were also excluded.

Design outcomes

Primary

MeasureTime frameDescription
preoperative and postoperative levels of bacterial loudone weekThe amounts of antibacterial loud was measured using a PCR kit.
preoperative and postoperative levels of antifungal loudone weekThe amounts of antifungal loud was measured using a PCR kit.
postoperative pain levelsone weekpostoperative pain levels will be describe using the visual analog scale (VAS). The VAS was classified using the following scale \[15\]: no pain (0); mild pain (1-3); moderate pain (4-6), and severe pain (7-10).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026