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Local Dexamethasone Administration in Symptomatic Irreversible Pulpitis (SIPDEX)

26 juni 2026 uppdaterad av: Marmara University

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

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

84

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Elif İrem Altıntaş, Research Assistant
  • Telefonnummer: +905425491411
  • E-post: eialtintas@icloud.com

Studera Kontakt Backup

Studieorter

  • Turkiet (Türkiye)
      • Istanbul, Turkiet (Türkiye)
        • Rekrytering
        • Marmara University Faculty of Dentistry

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Control Group
Participants receive an inferior alveolar nerve block followed by a submucosal saline injection prior to endodontic treatment.
Läkemedel: Saline (0.9%, sterile, for infusion)
Normal saline is administered submucosally following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis undergoing root canal treatment.
Experimentell: Submucosal Dexamethasone
Participants receive an inferior alveolar nerve block followed by submucosal dexamethasone administration prior to endodontic treatment.
Läkemedel: Dexamethasone
Dexamethasone (8 mg/2 mL) is administered submucosally following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis undergoing root canal treatment.
Läkemedel: Dexamethasone
Dexamethasone (8 mg/2 mL) is administered intraligamentarily following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis undergoing root canal treatment.
Experimentell: Intraligamentary Dexamethasone
Participants receive an inferior alveolar nerve block followed by intraligamentary dexamethasone administration prior to endodontic treatment.
Läkemedel: Dexamethasone
Dexamethasone (8 mg/2 mL) is administered submucosally following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis undergoing root canal treatment.
Läkemedel: Dexamethasone
Dexamethasone (8 mg/2 mL) is administered intraligamentarily following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis undergoing root canal treatment.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Success of Inferior Alveolar Nerve Block Anesthesia
Tidsram: Periprocedural (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.
Periprocedural (during access cavity preparation and pulp extirpation)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Postoperative Pain Intensity
Tidsram: 6, 12, 24, 48, and 72 hours after treatment
Postoperative pain intensity will be assessed using the Heft-Parker Visual Analog Scale (HP-VAS) at 6, 12, 24, 48, and 72 hours after treatment.
6, 12, 24, 48, and 72 hours after treatment
Need for Postoperative Analgesic Medication
Tidsram: Up to 72 hours after treatment
The 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.
Up to 72 hours after treatment

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Marmara University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 juni 2026

Primärt slutförande (Beräknad)

15 december 2026

Avslutad studie (Beräknad)

18 december 2026

Studieregistreringsdatum

Först inskickad

17 juni 2026

Först inskickad som uppfyllde QC-kriterierna

26 juni 2026

Första postat (Faktisk)

29 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • SIPDEX2026

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Individual participant data (IPD) will not be shared because there is no current data-sharing plan, and the study protocol and ethics approval do not include provisions for public sharing of individual participant-level data.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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