Skip to content

Local Dexamethasone Administration in Symptomatic Irreversible Pulpitis

Comparison of the Effects of Submucosal and Intraligamentary Dexamethasone Administration on Anesthetic Success and Pain Control in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07672873
Acronym
SIPDEX
Enrollment
84
Registered
2026-06-29
Start date
2026-06-15
Completion date
2026-12-18
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Pain, Symptomatic Irreversible Pulpitis (SIP)

Keywords

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

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.

Detailed description

Symptomatic irreversible pulpitis is associated with a high incidence of failure of inferior alveolar nerve block anesthesia, particularly in mandibular molars, resulting in pain during endodontic treatment and the frequent need for supplemental anesthesia. Corticosteroids have been investigated as adjunctive agents because of their anti-inflammatory properties and their potential to improve anesthetic success and reduce postoperative pain. However, limited evidence is available regarding the influence of different local administration techniques on these outcomes. This prospective, randomized, controlled, single-blind clinical trial aims to compare the effects of submucosal and intraligamentary administration of dexamethasone on anesthetic success and postoperative pain following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis of mandibular first or second molars. Eighty-four participants will be randomly allocated into three parallel groups (28 participants per group): Group 1 (Control): Inferior alveolar nerve block followed by submucosal injection of normal saline (placebo). Group 2: Inferior alveolar nerve block followed by submucosal injection of dexamethasone. Group 3: Inferior alveolar nerve block followed by intraligamentary injection of dexamethasone. The primary outcome is anesthetic success, assessed using the Heft-Parker Visual Analog Scale (HP-VAS) during access cavity preparation and pulp extirpation. Secondary outcomes include postoperative pain intensity assessed using the HP-VAS at 6, 12, 24, 48, and 72 hours after treatment, as well as the need for postoperative analgesic medication. The findings of this study may help identify the most effective local administration technique for dexamethasone to improve anesthetic success and postoperative pain management in patients with symptomatic irreversible pulpitis.

Interventions

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

DRUGDexamethasone

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

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Success of Inferior Alveolar Nerve Block AnesthesiaPeriprocedural (during access cavity preparation and pulp extirpation)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.

Secondary

MeasureTime frameDescription
Postoperative Pain Intensity6, 12, 24, 48, and 72 hours after treatmentPostoperative pain intensity will be assessed using the Heft-Parker Visual Analog Scale (HP-VAS) at 6, 12, 24, 48, and 72 hours after treatment.
Need for Postoperative Analgesic MedicationUp to 72 hours after treatmentThe need for postoperative analgesic medication will be assessed by recording whether participants require rescue analgesic medication during the 72-hour follow-up period after treatment.

Countries

Turkey (Türkiye)

Contacts

CONTACTElif İrem Altıntaş, Research Assistant
eialtintas@icloud.com+905425491411
CONTACTAyşe Karadayı, Assistant Professor
ayse.karadayi@marmara.edu.tr+905330527343

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026