Effect of Calcium Silicate-Based Root Canal Medicament After Retreatment

NCT06779370 | Completed

• 1 other identifier: 14244
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• preoperative and postoperative levels of bacterial loud

  The amounts of antibacterial loud was measured using a PCR kit.

  one week

• preoperative and postoperative levels of antifungal loud

  The amounts of antifungal loud was measured using a PCR kit.

  one week

• postoperative pain levels

  postoperative 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).

  one week

Study Arms (2)

calcium silicate based medicament

EXPERIMENTAL

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

Drug: Calcium Silicate

calcium hydroxide based medicament

ACTIVE COMPARATOR

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

Drug: Calcium hydroxide

Interventions

Calcium Silicate 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.

Also known as: calcium silicate based medicament group

calcium silicate based medicament

Calcium hydroxide 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.

calcium hydroxide based medicament

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (1)

• Mentes I, Sumbullu M. Effect of tricalcium silicate-based intracanal dressing on antibacterial-antifungal activity and postoperative pain intensity after non-surgical endodontic retreatment: randomized controlled clinical trial. Head Face Med. 2025 Nov 21;21(1):78. doi: 10.1186/s13005-025-00559-w.

  PMID: 41272686 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

calcium silicate; Calcium Hydroxide

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Officials

• meltem SÜMBÜLLÜ, DDS

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcome assessments have performed by a investigator who was blinded to groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Dr. Meltem Sümbüllü

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

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: January 16, 2025
• Study Start: June 12, 2024
• Primary Completion: December 12, 2024
• Study Completion: January 10, 2025
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)