Status:
COMPLETED
Dexamethasone Treatment for Patients Undergoing Endodontics
Lead Sponsor:
University of Salamanca
Conditions:
Endodontic Treatment
Pulp Necrosis
Eligibility:
All Genders
20-50 years
Phase:
PHASE4
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 followin...
Detailed Description
Background and Rationale: Endodontic treatment is a standard dental procedure aimed at preserving teeth with irreversible pulp damage or infection. A common complication following such procedures is ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT06906315
Start Date
November 4 2024
End Date
January 31 2025
Last Update
April 4 2025
Active Locations (1)
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1
University of Salamanca
Salamanca, Salamanca, Spain, 37008