Effect of Calcium Silicate Based Root Canal Medicament on Inflammatory Mediators

NCT06307678 | Completed

• 1 other identifier: AtaturkU-DHF-MS-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Periapical; Infection

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• preoperative and postoperative levels of prostaglandinE2 (PGE2) ratio

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

  one week

• preoperative and postoperative levels of TNF alpha ratio

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

  one week

• 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 Outcomes (1)

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

  one week

Study Arms (2)

calcium silicate based medicament

EXPERIMENTAL

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.

Drug: Calcium Silicate

calcium hydroxide based medicament

ACTIVE COMPARATOR

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.

Drug: Calcium Hydroxide

Interventions

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.

Also known as: calcium hydroxide based medicament group

calcium hydroxide based medicament

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.

Also known as: calcium silicate based medicament group

calcium silicate based medicament

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (1)

• Unal O, Sumbullu M, Laloglu E. Effect of tricalcium silicate-based intracanal dressing on bone resorption and inflammatory mediators in periapical lesions: a randomized controlled clinical trial. Odontology. 2025 Oct;113(4):1667-1677. doi: 10.1007/s10266-025-01093-6. Epub 2025 Mar 28.

  PMID: 40155539 DERIVED

MeSH Terms

Conditions

Infections; Camurati-Engelmann Syndrome

Interventions

Calcium Hydroxide; calcium silicate

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Officials

• meltem sümbüllü, DDS

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcome assessments have performed by a investigator who was blinded to groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: two groups: group 1 calcium hydroxide based medicament (control group) group 2: calcium silicate based medicament

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: July 7, 2023
• Primary Completion: December 10, 2023
• Study Completion: December 10, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)