Local Dexamethasone Administration in Symptomatic Irreversible Pulpitis

NCT07672873 | Recruiting

• 1 other identifier: SIPDEX2026
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Symptomatic irreversible pulpitis is associated with a high incidence of inadequate pulpal anesthesia during endodontic treatment, particularly in mandibular molar teeth. Failure to achieve profound anesthesia may result in increased intraoperative pain and patient discomfort. Corticosteroids have been suggested as adjunctive agents to improve pain control and reduce inflammatory responses; however, the influence of different local administration techniques on anesthetic success and postoperative pain remains unclear. The aim of this randomized controlled clinical trial is to compare the effects of submucosal and intraligamentary dexamethasone administration on anesthetic success and pain control in patients with symptomatic irreversible pulpitis. A total of 84 participants requiring root canal treatment of mandibular first or second molars diagnosed with symptomatic irreversible pulpitis will be randomly allocated to one of three groups: (1) inferior alveolar nerve block (IANB) followed by submucosal saline injection (control group), (2) IANB followed by submucosal dexamethasone injection, and (3) IANB followed by intraligamentary dexamethasone injection. All participants will receive standardized endodontic treatment under local anesthesia. The primary outcome measure is anesthetic success during access cavity preparation and pulp extirpation. Secondary outcome measures include postoperative pain intensity at 6, 12, 24, 48, and 72 hours, and postoperative analgesic consumption. The results of this study may provide evidence regarding the effectiveness of different local dexamethasone administration techniques and contribute to improved pain management strategies in endodontic practice.

Conditions

Symptomatic Irreversible Pulpitis (SIP); Dental Pain

Keywords

Inferior alveolar nerve block; Dexamethasone; Submucosal injection; Intraligamentary injection; Symptomatic irreversible pulpitis; Endodontic treatment; Postoperative pain; Heft-Parker Visual Analog Scale; HP-VAS

Outcome Measures

Primary Outcomes (1)

• Success of Inferior Alveolar Nerve Block Anesthesia

  Anesthetic success will be assessed using the Heft-Parker Visual Analog Scale (HP-VAS) during access cavity preparation and pulp extirpation. Successful anesthesia is defined as no pain or mild pain (HP-VAS \<54 mm) without the need for supplemental anesthesia. Moderate or severe pain (HP-VAS ≥54 mm) or the need for supplemental anesthesia will be considered anesthetic failure.

  Periprocedural (during access cavity preparation and pulp extirpation)

Secondary Outcomes (2)

• Postoperative Pain Intensity

  6, 12, 24, 48, and 72 hours after treatment

• Need for Postoperative Analgesic Medication

  Up to 72 hours after treatment

Study Arms (3)

Control Group

PLACEBO COMPARATOR

Participants receive an inferior alveolar nerve block followed by a submucosal saline injection prior to endodontic treatment.

Drug: Saline (0.9%, sterile, for infusion)

Submucosal Dexamethasone

EXPERIMENTAL

Participants receive an inferior alveolar nerve block followed by submucosal dexamethasone administration prior to endodontic treatment.

Drug: Dexamethasone

Intraligamentary Dexamethasone

EXPERIMENTAL

Participants receive an inferior alveolar nerve block followed by intraligamentary dexamethasone administration prior to endodontic treatment.

Drug: Dexamethasone

Interventions

Saline (0.9%, sterile, for infusion) DRUG

Normal saline is administered submucosally following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis undergoing root canal treatment.

Control Group

Dexamethasone DRUG

Dexamethasone (8 mg/2 mL) is administered submucosally following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis undergoing root canal treatment.

Submucosal Dexamethasone

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 aged 18 to 65 years.
• ASA I or ASA II systemic health status.
• Symptomatic irreversible pulpitis in a mandibular molar tooth.
• Positive response to pulp sensibility tests.
• Preoperative pain score greater than 54 mm on the Heft-Parker Visual Analog Scale (HP-VAS).
• Ability to understand the study procedures and provide written informed consent.

You may not qualify if:

• Pregnancy or lactation.
• Allergy or contraindication to articaine, dexamethasone, or study-related medications.
• Use of analgesics, anti-inflammatory drugs, or antibiotics within the previous 12 hours.
• Presence of periapical radiolucency or diagnosis of pulpal necrosis.
• Significant systemic disease (ASA III or higher).
• Inability to complete pain assessment forms or follow study procedures.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Faculty of Dentistry

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Toothache; Pain, Postoperative

Interventions

Sodium Chloride; Dexamethasone

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Elif İrem Altıntaş, Research Assistant

CONTACT

+905425491411; eialtintas@icloud.com

Ayşe Karadayı, Assistant Professor

CONTACT

+905330527343; ayse.karadayi@marmara.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 29, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 18, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)