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Effect of Calcium Silicate Based Root Canal Medicament on Inflammatory Mediators

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06307678
Enrollment
60
Registered
2024-03-13
Start date
2023-07-07
Completion date
2023-12-10
Last updated
2024-03-13

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

Conditions

Periapical; Infection

Keywords

intracanal medicament, intracanal dressing, RANKL, osteoprotegerin, TNF alpha, TGF beta, prostaglandin E2

Brief 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.

Detailed 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.

Interventions

DRUGCalcium 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.

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.

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 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
preoperative and postoperative levels of RANKL/OPG ratioone weekThe amounts of cytokines RANKL and OPG were measured using an enzyme-linked immunosorbent assay kit.
preoperative and postoperative levels of prostaglandinE2 (PGE2) ratioone weekThe amounts of PGE2 were measured using an enzyme-linked immunosorbent assay kit.
preoperative and postoperative levels of TNF alpha ratioone weekThe amounts of TNF alpha were measured using an enzyme-linked immunosorbent assay kit.
preoperative and postoperative levels of TGF beta ratioone weekThe amounts of TGF beta were measured using an enzyme-linked immunosorbent assay kit.

Secondary

MeasureTime frameDescription
dependent variables (sex, age, teeth number, smoking habit)one weekDid the teeth number, age, sex, smoking habit have any effect on pretreatment or posttreatment levels of RANKL/OPG, PGE2, TNF alpha, TGF beta?

Countries

Turkey (Türkiye)

Outcome results

None listed

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