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Completed

NCT Number: NCT07704398

Effect of Corticosteroid Injection in Symptomatic Pulpitis Cases

This randomized clinical trial compared standard single-visit root canal treatment with adjunctive submucosal betamethasone and gentamicin in 100 patients with symptomatic irreversible pulpitis, assessing postoperative pain and inflammatory biomarkers (IL-1β, MMP-9, and RANKL).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yelda Erdem Hepşenoğlu

Istanbul, Atakent Mahallesi, Turkey (Türkiye)

About this study

This study was designed as a prospective, randomized controlled clinical trial. A total of 100 patients with a VAS pain score ≥7 and SIP in posterior teeth were included. Participants were randomly assigned into two groups: a standard root canal treatment group (n = 40) and an adjunctive treatment group receiving submucosal betamethasone and gentamicin (n = 60). In all cases, conventional single-visit root canal treatment was performed. Gingival crevicular fluid (GCF) samples were collected preoperatively and on postoperative day 3, and VAS scores were recorded at the same time points. Levels of IL-1β, MMP-9, and RANKL in GCF samples were quantified using enzyme-linked immunosorbent assay (ELISA).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients diagnosed with symptomatic irreversible pulpitis
  • Presence of spontaneous pain or pain persisting after removal of the stimulus
  • Teeth indicated for endodontic treatment
  • Systemically healthy individuals
  • Patients able to read and sign the informed consent form
  • Patients able to complete postoperative pain assessment forms
  • Patients able to attend the 4-day follow-up visit

Exclusion criteria

  • Individuals with systemic disease or immunosuppression
  • Patients with contraindications to corticosteroid or gentamicin use
  • Pregnant or breastfeeding individuals
  • Recent use of antibiotics, analgesics, or anti-inflammatory drugs
  • Presence of advanced periodontal disease in the affected tooth
  • Presence of acute periapical or periodontal abscess
  • Teeth with previous endodontic treatment

Treatment and study plan

Corticosteroid

Drug

One hundred patients were randomly assigned to either the standard treatment group receiving conventional root canal treatment (control, n = 40) or the adjunctive treatment group receiving conventional root canal treatment combined with submucosal betamethasone and gentamicin injection (n = 60) by the Research Randomizer programme (accessed at www.randomizer.org).

Standard endodontic treatment

Other

standard treatment group receiving conventional root canal treatment

Primary outcomes

  1. Gingival Crevicular Fluid Matrix Metalloproteinase-9 (MMP-9) Concentration

    Time frame: Baseline and post-treatment day 3

    MMP-9 levels in gingival crevicular fluid will be quantified using enzyme-linked immunosorbent assay (ELISA).

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Effect of Submucosal Corticosteroid Injection on Inflammatory Biomarkers and Postoperative Pain in Patients With Symptomatic Pulpitis

Acronym: (SCIP)

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

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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