Effect of Calcium Silicate Based Root Canal Medicament on Inflammatory Mediators

Periapical; Infection Clinical Trial

Official title:

EFFECT OF CALCIUM SILICATE-BASED ROOT CANAL MEDICAMENT ON RELEASE OF BONE RESORPTION AND INFLAMMATION MEDIATORS IN PERIAPICAL LESIONS: A RANDOMISED CONTROLLED CLINICAL TRIAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06307678
• Other study ID #: AtaturkU-DHF-MS-01
• Status: Completed
• Phase: N/A
• Start date: July 7, 2023
• Est. completion date: December 10, 2023

Study information

• Verified date: March 2024
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Calcium hydroxide is generally preferred in endodontics as an intracanal medicament because of its antimicrobial and biological effects. However, the antimicrobial effect of calcium hydroxide is limited.

The aim of this study was to investigate the effects of calcium silicate-based root canal medicament on the release of RANKL/OPG, TNF-α, PGE-2 and TGF-β1 in root canal treated teeth with periapical lesions.

Description:

Sixty patients were randomly divided into two groups using a web program according to the medication selected: Calcium silicate based root canal medicament or calcium hydroxide based root canal medicament.

After removing gutta-percha from the root canals, RANKL/OPG, TNF-α, PGE-2 and TGF- β1 samples were taken from the interstitial fluid of the apical tissues using three paper points.

At the second appointment, medicaments were removed and second sampling was performed using the same method. RANKL/OPG, TNF-α, PGE-2 and TGF- β1 levels were measured by enzyme-linked immunosorbent assay and their ratios were calculated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 10, 2023
• Est. primary completion date: December 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Incisor, canine, and premolar teeth that had previously undergone root canal treatment (cases with persistent and secondary disease) and presented with a diagnosis of chronic apical abscess or asymptomatic apical periodontitis were included. Incisor, canine, and premolar teeth with only 1 root canal were included in the study to avoid untreated extra root canals and difficulties in the preparation, obturation, and restoration of molar teeth and to make treatments more standardized.The patients had not used any antibiotics for 3 months before treatment, and patients were obviously free of systemic diseases.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Periapical; Infection

Intervention

Drug:
• Calcium Hydroxide
The samples were taken from the interstitial fluid of the apical tissues using 3 paper points before medicament placement. Calcium hydroxide based medicament was placed in the canals using a file at a distance of 1 or 2 mm less than the root canal length. At the second appointment, medicamentswere removed, and second samplingwas performed using the same method. The RANKL/OPG, TNF alpha, TGF beta, PGE2 levels were measured by the enzyme-linked immunosorbent assay, and their ratio was calculated.
• Calcium Silicate
The samples were taken from the interstitial fluid of the apical tissues using 3 paper points before medicament placement. Calcium silicate based medicament was placed in the canals using a file at a distance of 1 or 2 mm less than the root canal length. At the second appointment, medicaments were removed, and second sampling was performed using the same method. The RANKL/OPG, TNF alpha, TGF beta, PGE2 levels were measured by the enzyme-linked immunosorbent assay, and their ratio was calculated.

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preoperative and postoperative levels of RANKL/OPG ratio	The amounts of cytokines RANKL and OPG were measured using an enzyme-linked immunosorbent assay kit.	one week
Primary	preoperative and postoperative levels of prostaglandinE2 (PGE2) ratio	The amounts of PGE2 were measured using an enzyme-linked immunosorbent assay kit.	one week
Primary	preoperative and postoperative levels of TNF alpha ratio	The amounts of TNF alpha were measured using an enzyme-linked immunosorbent assay kit.	one week
Primary	preoperative and postoperative levels of TGF beta ratio	The amounts of TGF beta were measured using an enzyme-linked immunosorbent assay kit.	one week
Secondary	dependent variables (sex, age, teeth number, smoking habit)	Did the teeth number, age, sex, smoking habit have any effect on pretreatment or posttreatment levels of RANKL/OPG, PGE2, TNF alpha, TGF beta?	one week