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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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Turkey
Marmara University Faculty of Dentistry
RECRUITING
Istanbul
Contact Information
Primary
Elif İrem Altıntaş, Research Assistant
eialtintas@icloud.com
+905425491411
Backup
Ayşe Karadayı, Assistant Professor
ayse.karadayi@marmara.edu.tr
+905330527343
Time Frame
Start Date: 2026-06-15
Estimated Completion Date: 2026-12-18
Participants
Target number of participants: 84
Treatments
Placebo_comparator: Control Group
Participants receive an inferior alveolar nerve block followed by a submucosal saline injection prior to endodontic treatment.
Experimental: Submucosal Dexamethasone
Participants receive an inferior alveolar nerve block followed by submucosal dexamethasone administration prior to endodontic treatment.
Experimental: Intraligamentary Dexamethasone
Participants receive an inferior alveolar nerve block followed by intraligamentary dexamethasone administration prior to endodontic treatment.
Related Therapeutic Areas
Sponsors
Leads: Marmara University

This content was sourced from clinicaltrials.gov