Clinical trial NCT06307678: Effect of Calcium Silicate Based Root Canal Medicament on Inflammatory Mediators
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periapical; Infection
Keywords: intracanal medicament
intracanal dressing
RANKL
osteoprotegerin
TNF alpha
TGF beta
prostaglandin E2
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups: group 1 calcium hydroxide based medicament (control group) group 2: calcium silicate based medicament
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: preoperative and postoperative levels of RANKL/OPG ratio
timeFrame: one week
measure: preoperative and postoperative levels of prostaglandinE2 (PGE2) ratio
timeFrame: one week
measure: preoperative and postoperative levels of TNF alpha ratio
timeFrame: one week
measure: preoperative and postoperative levels of TGF beta ratio
timeFrame: one week
Secondary outcomes:
measure: dependent variables (sex, age, teeth number, smoking habit)
timeFrame: one week
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
affiliation: Ataturk University
name: meltem sümbüllü, DDS
role: PRINCIPAL_INVESTIGATOR
References: