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Clinical Trials/NCT06307678
NCT06307678
Completed
Not Applicable

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

Ataturk University1 site in 1 country60 target enrollmentJuly 7, 2023

Overview

Phase
Not Applicable
Intervention
Calcium Silicate
Conditions
Periapical; Infection
Sponsor
Ataturk University
Enrollment
60
Locations
1
Primary Endpoint
preoperative and postoperative levels of TGF beta ratio
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 7, 2023
End Date
December 10, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Meltem Sümbüllü

Assistant Professor

Ataturk University

Eligibility Criteria

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.

Arms & Interventions

calcium silicate based medicament

Root canal lengths were determined by an electronic apex locator with a 15-K file R25 and R50 Reciproc files were used at working lengths to complete the canal preparation. During instrumentation, the root canals were irrigated with 2 mL 1% NaOCl. To obtain the first samples, 3 sterile paper points were placed into the root canals beyond the 2-mm root apex and were kept in position for 60 seconds. Thereafter, the paper points were cut 4 mm from the tip30. Afterward, root canals were dried with paper points, and 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. Next, the coronal cavities were restored with temporary material. Seven days later, the medication was mechanically removed using a master apical file. Subsequently, root canals were irrigated.The final samples were collected from the interstitial fluid of the apical tissue as previously described.

Intervention: Calcium Silicate

calcium hydroxide based medicament

Root canal lengths were determined by an electronic apex locator with a 15-K file R25 and R50 Reciproc files were used at working lengths to complete the canal preparation. During instrumentation, the root canals were irrigated with 2 mL 1% NaOCl. To obtain the first samples, 3 sterile paper points were placed into the root canals beyond the 2-mm root apex and were kept in position for 60 seconds. Thereafter, the paper points were cut 4 mm from the tip30. Afterward, root canals were dried with paper points, and 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. Next, the coronal cavities were restored with temporary material. Seven days later, the medication was mechanically removed using a master apical file. Subsequently, root canals were irrigated.The final samples were collected from the interstitial fluid of the apical tissue as previously described.

Intervention: Calcium Hydroxide

Outcomes

Primary Outcomes

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.

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.

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.

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.

Secondary Outcomes

  • dependent variables (sex, age, teeth number, smoking habit)(one week)

Study Sites (1)

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