Effect of Corticosteroid Injection in Symptomatic Pulpitis Cases ((SCIP))

July 10, 2026 updated by: Seyda Ersahan, DDS, PhD, Istanbul Medipol University Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control Group
Patients in this group will undergo traditional root canal treatment under local anesthesia.
Other: Standard endodontic treatment
standard treatment group receiving conventional root canal 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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and post-treatment day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Investigators

  • Study Director: Seyda Ersahan, Assoc.Prof., Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2023

Primary Completion (Actual)

April 23, 2026

Study Completion (Actual)

April 23, 2026

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

July 10, 2026

First Posted (Actual)

July 15, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-10840098-772.02-6287

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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