Effect of Calcium Silicate-Based Root Canal Medicament After Retreatment

NCT ID: NCT06779370

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-12
• Study Completion Date: 2025-01-10

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.

Conditions

Antibacterial Agents; Postoperative Dental Pain; Antifungal Agents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

calcium silicate based medicament

Root canal lengths were determined using an electronic apex locator and a 15-K file. R25 Reciproc files were used at working lengths to remove the root canal filling. During instrumentation, the root canals were irrigated with saline solution. To obtain the first samples, three sterile paper points were placed at working length and the samples were transferred to an Eppendorf tube containing distilled water.

Subsequently, the root canals were chemomechanically prepared, final irrigation activation was performed, and the 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 assess the patients' postoperative pain levels over one week.

At the second appointment, the medicament was removed, and third samples were collected using paper points with the same technique to evaluate antibacterial and antifungal effects. The root canal treatments of

Group Type: EXPERIMENTAL

Calcium Silicate

Intervention Type: DRUG

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.

calcium hydroxide based medicament

Root canal lengths were determined using an electronic apex locator and a 15-K file. R25 Reciproc files were used at working lengths to remove the root canal filling. During instrumentation, the root canals were irrigated with saline solution. To obtain the first samples, three sterile paper points were placed at working length and the samples were transferred to an Eppendorf tube containing distilled water.

Subsequently, the root canals were chemomechanically prepared, final irrigation activation was performed, and the 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 assess the patients' postoperative pain levels over one week.

At the second appointment, the medicament was removed, and third samples were collected using paper points with the same technique to evaluate antibacterial and antifungal effects. The root canal treatments of

Group Type: ACTIVE_COMPARATOR

Calcium hydroxide

Intervention Type: DRUG

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.

Interventions

Calcium Silicate

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.

Intervention Type: DRUG

Calcium 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.

Intervention Type: DRUG

Other Intervention Names

calcium silicate based medicament group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Meltem Sümbüllü

Assistant Professor Dr. Meltem Sümbüllü

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

meltem SÜMBÜLLÜ, DDS

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

Locations

Ataturk University

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

14244

Identifier Type: -

Identifier Source: org_study_id