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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
Phase 4 trial testing Amoxicillin in Healthy in 18 participants. Completed in 25 July 2024.
27 May 2024
Quick facts
| Lead sponsor | Universidad Católica San Antonio de Murcia |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | supportive care |
| Enrollment | 18 |
| Start date | 5 October 2023 |
| Primary completion | 27 May 2024 |
| Estimated completion | 25 July 2024 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Amoxicillin (amoxicillin) — full drug profile →
- Placebo
Conditions studied
- Healthy — all drugs for Healthy →
- Third Molar Extraction Surgery — all drugs for Third Molar Extraction Surgery →
- Antibiotic Prophylaxis — all drugs for Antibiotic Prophylaxis →
- Amoxicillin — all drugs for Amoxicillin →
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):
-
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
Verify or expand the search:
- PubMed search for NCT06613776
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06613776 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidad Católica San Antonio de Murcia
- Last refreshed: 26 September 2024
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