Clinical trial 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
Official title: Evaluation of the Effect of Antibiotic Prophylaxis on Inflammatory Factor in Salivary Samples After Third Molars Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Third Molar Extraction Surgery
Antibiotic Prophylaxis
Amoxicillin
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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\&#39;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.


Eligibility criteria: Inclusion Criteria:

* Healthy people (ASA I \&amp; II)
* Older than 18 years
* No history of viral or microbial diseases during the last four months
* No history of allergic reaction to penicillin-class antibiotics or other drugs that will be used during the research
* No history of anti-inflammatory or contraceptive drugs use during the last month
* Not being in pregnancy or nursing period for women
* Having at least one unerupted mandibular wisdom tooth needs surgical intervention

Exclusion Criteria:

* History of dental pain, inflammation, or abscess during the last month
* thyroid hormone therapy
* unwillingness to participate in the study.

Primary outcomes:
measure: Pain reported by patients
timeFrame: From the first visit immediately after surgery to the last visit, 6 days.
Secondary outcomes:
measure: Maximum mouth opening change
timeFrame: From the initial visit before surgery to the final visit 7 days post-surgery, at 7 days
measure: Facial swelling
timeFrame: From the day of surgery to the last visit, at 7 days
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: UCAM dental, Clinica odontologica universitaria
Study officials:
References:
citation: Torof E, Morrissey H, Ball PA. The Role of Antibiotic Use in Third Molar Tooth Extractions: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2023 Feb 21;59(3):422. doi: 10.3390/medicina59030422.
citation: Mehra P, Reebye U, Nadershah M, Cottrell D. Efficacy of anti-inflammatory drugs in third molar surgery: a randomized clinical trial. Int J Oral Maxillofac Surg. 2013 Jul;42(7):835-42. doi: 10.1016/j.ijom.2013.02.017. Epub 2013 Mar 25.