Effect of Corticosteroid Injection in Symptomatic Pulpitis Cases

NCT07704398 | Completed DMC

• 1 other identifier: E-10840098-772.02-6287
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Periapical Periodontitis

Keywords

Corticosteroid; Anesthesia; apical periodontitis; Root canal treatment

Outcome Measures

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).

  Baseline and post-treatment day 3

Study Arms (2)

Control Group

EXPERIMENTAL

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

Other: Standard endodontic treatment

adjunctive treatment group

EXPERIMENTAL

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

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).

adjunctive treatment group

Standard endodontic treatment OTHER

standard treatment group receiving conventional root canal treatment

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Yelda Erdem Hepşenoğlu

Istanbul, Atakent Mahallesi, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Seyda Ersahan, Assoc.Prof.

  Medipol University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Associate Professor

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: July 15, 2026
• Study Start: October 23, 2023
• Primary Completion: April 23, 2026
• Study Completion: April 23, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

TU (1)