Clinical trial NCT06779370: Effect of Calcium Silicate-Based Root Canal Medicament After Retreatment
Official title: Evaluation of the Effect of Calcium Silicate-Based Root Canal Medicament on Antifungal-Antibacterial Activity and Post-Operative Pain After Retreatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antibacterial Agents
Postoperative Dental Pain
Antifungal Agents
Keywords: calcium silicate based root canal medicament
calcium hydroxide based root canal medicament
bacterial load
antibacterial effect
antifungal effect
postoperative pain
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups: group 1 calcium hydroxide based medicament (control group) group 2: calcium silicate based medicament
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: preoperative and postoperative levels of bacterial loud
timeFrame: one week
measure: preoperative and postoperative levels of antifungal loud
timeFrame: one week
measure: postoperative pain levels
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
affiliation: Ataturk University
name: meltem SÜMBÜLLÜ, DDS
role: PRINCIPAL_INVESTIGATOR
References: