Dexamethasone Treatment for Patients Undergoing Endodontics

NCT06906315 | Completed Phase 4

• 2 other identifiers: U1111-1320-42082025_01/345
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase IV randomized clinical trial (RCT) evaluated the efficacy of preoperative administration of a single 4 mg oral dose of dexamethasone in reducing postoperative pain and inflammation following endodontic treatment. Conducted at the Department of Endodontics, PhD Program, Faculty of Dentistry, University of Salamanca, the study included 82 participants who were randomly assigned to either the test group (preoperative dexamethasone) or the control group (postoperative ibuprofen 400 mg every 4 hours). Pain intensity was measured using the Visual Analog Scale (VAS) at 4, 6, 8, 12, and 24 hours postoperatively. Results indicated significantly lower pain perception in the dexamethasone group compared to the ibuprofen group at all time points, with the majority of dexamethasone-treated patients reporting only mild pain. No adverse effects were observed in either group, and no patient required additional rescue analgesia. The findings suggest that a single preoperative dose of dexamethasone is a safe and effective strategy for managing postoperative pain in endodontic procedures, providing superior analgesia compared to the standard postoperative ibuprofen regimen. Keywords: Endodontic pain, dexamethasone, preoperative analgesia, randomized clinical trial, inflammation control, corticosteroids, endodontics.

Conditions

Endodontic Treatment; Pulp Necrosis; Periapical Lesions; Postoperative Pain

Keywords

Endodontic Pain Management; Dexamethasone; Postoperative Pain; Corticosteroids in Endodontics; Visual Analog Scale (VAS)

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity (Visual Analog Scale Score)

  Description: Pain intensity will be measured using the Visual Analog Scale (VAS), a 10-centimeter horizontal line where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Participants will mark their perceived pain levels at each time point to assess postoperative discomfort following endodontic treatment. Scale Range: 0 (no pain) to 10 (worst pain) Interpretation: Higher scores indicate a worse outcome (greater pain intensity).

  4, 6, 8, 12, and 24 hours post-endodontic treatment

Secondary Outcomes (1)

• Need for Rescue Analgesia

  24 hours post-endodontic treatment

Other Outcomes (4)

• Adverse Effects

  Up to 24 hours post-treatment

• Gender-Based Pain Response

  4, 6, 8, 12, and 24 hours post-treatment

• Inflammatory Symptoms

  24 hours post-treatment

Study Arms (2)

Dexamethasone Group

EXPERIMENTAL

Participants in this group received a single 4 mg oral dose of dexamethasone 1 hour before undergoing endodontic treatment. No additional preoperative analgesics were administered. Standard endodontic procedures, including local anesthesia, were performed. Post-treatment, no routine analgesic medication was provided unless additional pain relief was required. Pain intensity was assessed at 4, 6, 8, 12, and 24 hours using the Visual Analog Scale (VAS) to evaluate the efficacy of preoperative dexamethasone in controlling postoperative pain and inflammation. Arm 2

Drug: Dexamethasone 4 mg

Ibuprofen Group

ACTIVE COMPARATOR

Participants in this group received no preoperative medication but were prescribed 400 mg of ibuprofen every 4 hours postoperatively for pain management. The same standard endodontic procedures were performed. Pain levels were recorded at 4, 6, 8, 12, and 24 hours using the VAS scale to compare the effectiveness of postoperative ibuprofen with preoperative dexamethasone.

Drug: Ibuprofen group

Interventions

Dexamethasone 4 mg DRUG

Participants in this group received a single 4 mg oral dose of dexamethasone 1 hour before undergoing endodontic treatment. No additional preoperative analgesics were administered. Standard endodontic procedures, including local anesthesia, were performed. Post-treatment, no routine analgesic medication was provided unless additional pain relief was required. Pain intensity was assessed at 4, 6, 8, 12, and 24 hours using the Visual Analog Scale (VAS) to evaluate the efficacy of preoperative dexamethasone in controlling postoperative pain and inflammation.

Dexamethasone Group

Ibuprofen group DRUG

Participants in this group received no preoperative medication but were prescribed 400 mg of ibuprofen every 4 hours postoperatively for pain management. The same standard endodontic procedures were performed. Pain levels were recorded at 4, 6, 8, 12, and 24 hours using the VAS scale to compare the effectiveness of postoperative ibuprofen with preoperative dexamethasone.

Ibuprofen Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must meet all of the following criteria to be eligible for the study:
• Age Range: 20 to 50 years old.
• Indication for Endodontic Treatment: Patients requiring root canal therapy due to irreversible pulpitis (with or without apical lesion), pulp necrosis, retreatment with periapical lesion, or endodontic surgery.
• Eligible Teeth: Any dental group (anterior, premolar, molar, both maxillary and mandibular).
• General Health Status: Classified as ASA I (healthy individuals without systemic conditions) according to the American Society of Anesthesiologists (ASA) Physical Status Classification.
• Consent: Willingness to participate in the study and ability to provide signed informed consent.

You may not qualify if:

• Participants will be excluded if any of the following conditions apply:
• Age: Under 20 or over 50 years old.
• Medical Conditions:
• Immunocompromised individuals (e.g., HIV/AIDS, cancer patients undergoing chemotherapy).
• Systemic diseases such as diabetes mellitus, osteoporosis, acute psychosis, glaucoma, cataracts.
• Patients with tuberculosis or systemic fungal infections. Gastrointestinal conditions such as ulcerative colitis, peptic ulcers, or diverticulitis.
• Medication Use: Use of NSAIDs or corticosteroids within 48 hours prior to the intervention. Regular use of barbiturates.
• Dental Factors: Tooth fractures involving the roots. Severe dental hypersensitivity that may interfere with pain assessment.
• Pregnancy and Lactation: Pregnant or breastfeeding women will be excluded due to potential effects of dexamethasone.
• Non-Compliance: Patients who decline participation or are unwilling to follow study procedures, including pain assessment and follow-up.

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

University of Salamanca

Salamanca, Salamanca, 37008, Spain

Location

MeSH Terms

Conditions

Dental Pulp Necrosis; Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Javier Flores- Fraile Supervisor PI, PhD in Surgery and Dentistry

  University of Salamanca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study follows a parallel assignment interventional model, where participants were randomly assigned to one of two groups: Dexamethasone Group: Received a single 4 mg oral dose of dexamethasone 1 hour before endodontic treatment. Ibuprofen Group: Received no preoperative medication but took 400 mg of ibuprofen every 4 hours postoperatively for pain management. Both groups underwent the same standardized endodontic procedure, ensuring that the only variable was the pain management intervention. This was a single-blind study where participants were blinded to treatment allocation. Randomization was performed in a 1:1 ratio using simple randomization. The primary outcome was postoperative pain intensity, measured using the VAS scale at 4, 6, 8, 12, and 24 hours. Secondary outcomes included rescue analgesia use and adverse effects.

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: April 2, 2025
• Study Start: November 4, 2024
• Primary Completion: December 27, 2024
• Study Completion: January 31, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)