An interventional study of Saline (0.9%, sterile, for infusion) and Dexamethasone in Symptomatic Irreversible Pulpitis (SIP) and Dental Pain, sponsored by Marmara University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Marmara University · Not applicable, Interventional, and Treatment
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.
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.
142 studies on the registry are indexed under Toothache; 28 are open to participants now.
This study's planned enrollment of 84 is close to the median of 84 across 123 interventional studies indexed under Toothache.
Browse Toothache studies →Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive an inferior alveolar nerve block followed by a submucosal saline injection prior to endodontic treatment.
Drug: Saline (0.9%, sterile, for infusion)
Participants receive an inferior alveolar nerve block followed by submucosal dexamethasone administration prior to endodontic treatment.
Drug: Dexamethasone
Participants receive an inferior alveolar nerve block followed by intraligamentary dexamethasone administration prior to endodontic treatment.
Drug: Dexamethasone
Normal saline is administered submucosally following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis undergoing root canal treatment.
Dexamethasone (8 mg/2 mL) is administered submucosally following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis undergoing root canal treatment.
Dexamethasone (8 mg/2 mL) is administered intraligamentarily following inferior alveolar nerve block in patients with symptomatic irreversible pulpitis undergoing root canal treatment.
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.
Time frame: Periprocedural (during access cavity preparation and pulp extirpation)
Postoperative Pain Intensity
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.
Time frame: 6, 12, 24, 48, and 72 hours after treatment
Need for Postoperative Analgesic Medication
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.
Time frame: Up to 72 hours after treatment
Plan to share: No — 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.
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2026, 6 months after the start.
Of 44 non-industry interventional studies with no phase under Toothache, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 6 months is above that.
Counting every sponsor, half of 45 studies reached it within 5 months; a quarter within 3 and three quarters within 12.
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Studies of the drug tested here: Dexamethasone