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NCT06613776

Evaluation of the Effect of Antibiotic Prophylaxis (2g Amoxicillin One Hour Before Surgery) on an Inflammatory Factor (PGE2) in Salivary Samples After Third Molars Surgery

Completed Phase 4 Last updated 26 September 2024
What this trial tests

Phase 4 trial testing Amoxicillin in Healthy in 18 participants. Completed in 25 July 2024.

Timeline
5 October 2023
Primary endpoint
27 May 2024
25 July 2024

Quick facts

Lead sponsorUniversidad Católica San Antonio de Murcia
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposesupportive care
Enrollment18
Start date5 October 2023
Primary completion27 May 2024
Estimated completion25 July 2024
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Universidad Católica San Antonio de Murcia

Who can join

18 and older, any sex, with Healthy or Third Molar Extraction Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This clinical trial aims to evaluate the impact of antibiotics on inflammation and pain in patients who have undergone mandibular third molar surgery. The primary research questions are: 1. Do antibiotics reduce pain following third molar surgery? 2. Do antibiotics influence facial swelling and the patient\'s ability to open their mouth? 3. Do antibiotics affect the levels of a specific inflammatory marker in saliva post-surgery? Participants will be randomly assigned to receive either antibiotic capsules or placebo capsules. The study will include the following procedures: Medication: Participants will take four capsules (either antibiotics or placebo) as part of their standard surgical care. Saliva Samples: Saliva samples will be collected at three time points: before surgery, 24 hours after surgery, and 7 days post-surgery. Measurements: Facial swelling and mouth opening will be assessed by the investigator at each time point. By comparing the outcomes between the antibiotic and placebo groups, researchers aim to determine the effectiveness of antibiotics in managing post-surgical inflammation and pain.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effect of Antibiotics on Clinical and Laboratory Outcomes After Mandibular Third Molar Surgery: A Double-Blind Randomized Clinical Trial.
    Soleymani F, Maté Sánchez de Val JE, Lijnev A, Makiabadi M, et al · · 2025 · PMID 40001438 · DOI 10.3390/antibiotics14020195

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Other trials of Amoxicillin

Trials testing the same drug.

Other recruiting trials for Healthy

Currently open trials in the same condition.

Other Universidad Católica San Antonio de Murcia trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06613776.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing