CClinicalTrials.gg
CompletedNCT07704398(SCIP)Updated Jul 15, 2026

Effect of Corticosteroid Injection in Symptomatic Pulpitis Cases

An interventional study of Corticosteroid and Standard endodontic treatment in Periapical Periodontitis, sponsored by Istanbul Medipol University Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-15.

Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Oct 2023, registered May 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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).

Read the detailed description

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).

02

Conditions studied

  • Periapical Periodontitis

Keywords

  • Corticosteroid
  • Anesthesia
  • apical periodontitis
  • Root canal treatment
03

In context

Periapical Periodontitis

246 studies on the registry are indexed under Periapical Periodontitis; 64 are open to participants now.

This study's enrollment of 100 is above the median of 60 across 210 interventional studies indexed under Periapical Periodontitis.

Browse Periapical Periodontitis studies →

Lead sponsor

Istanbul Medipol University Hospital is the lead sponsor of 350 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Control Group

    Patients in this group will undergo traditional root canal treatment under local anesthesia.

    Other: Standard endodontic treatment

  • Experimental
    adjunctive treatment group

    Patients in this group will receive submucosal injections following local anesthesia: * Betamethasone * Gentamicin Then, root canal treatment will be performed in the same way as the control group.

    Drug: Corticosteroid

Interventions

  • DrugCorticosteroid

    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).

  • OtherStandard endodontic treatment

    standard treatment group receiving conventional root canal treatment

06

What researchers measure

Primary outcomes

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

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

    Time frame: Baseline and post-treatment day 3

07

Study locations

1 site
  • Yelda Erdem Hepşenoğlu
    Istanbul, Atakent Mahallesi, Turkey (Türkiye)
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07704398
Lead sponsor
Istanbul Medipol University Hospital
Responsible party
Seyda Ersahan, DDS, PhD (Principal Investigator, Clinical Associate Professor, Istanbul Medipol University Hospital) — Principal investigator
First posted
Jul 15, 2026
Start date
Oct 23, 2023
Primary completion
Apr 23, 2026
Completion
Apr 23, 2026
Last update
Jul 15, 2026

Study contacts

Seyda Ersahan, Assoc.Prof.
study director · Medipol University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion