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Completed

NCT Number: NCT06307678

Effect of Calcium Silicate Based Root Canal Medicament on Inflammatory Mediators

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.

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Key information

Conditions

Periapical; Infection Bone Diseases Bone Diseases, Developmental Camurati-Engelmann Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Infections Musculoskeletal Diseases Osteochondrodysplasias

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Calcium hydroxide

Drug

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.

Other names: calcium hydroxide based medicament group

Calcium Silicate

Drug

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.

Other names: calcium silicate based medicament group

Primary outcomes

  1. preoperative and postoperative levels of RANKL/OPG ratio

    Time frame: one week

    The amounts of cytokines RANKL and OPG were measured using an enzyme-linked immunosorbent assay kit.

  2. preoperative and postoperative levels of prostaglandinE2 (PGE2) ratio

    Time frame: one week

    The amounts of PGE2 were measured using an enzyme-linked immunosorbent assay kit.

  3. preoperative and postoperative levels of TNF alpha ratio

    Time frame: one week

    The amounts of TNF alpha were measured using an enzyme-linked immunosorbent assay kit.

  4. preoperative and postoperative levels of TGF beta ratio

    Time frame: one week

    The amounts of TGF beta were measured using an enzyme-linked immunosorbent assay kit.

Secondary outcomes

  1. dependent variables (sex, age, teeth number, smoking habit)

    Time frame: one week

    Did the teeth number, age, sex, smoking habit have any effect on pretreatment or posttreatment levels of RANKL/OPG, PGE2, TNF alpha, TGF beta?

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 13, 2024
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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