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

Completed

• Conditions: Healthy; Third Molar Extraction Surgery; Antibiotic Prophylaxis; Amoxicillin
• Interventions: Drug: Placebo; Drug: Amoxicillin

• Registration Number: NCT06613776
• Lead Sponsor: Universidad Católica San Antonio de Murcia

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\'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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-05
• Primary Completion: 2024-05-27
• Study Completion: 2024-07-25
• Status Verified: 2024-09
• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-23
• Last Update Submitted: 2024-09-23
• Study First Posted: 2024-09-26
• Last Update Posted: 2024-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Healthy people (ASA I & 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group (Placebo)	Placebo	4 empty amoxicillin 500mg capsules
intervention group (Antibiotic)	Amoxicillin	4 amoxicillin 500 mg capsules (2 grams)

Primary Outcome Measures

Name	Time	Method
Pain reported by patients	From the first visit immediately after surgery to the last visit, 6 days.	Pain levels are assessed using a Visual Analog Scale (VAS) and a 10-point scale at several intervals: immediately after surgery, at 6 hours, 12 hours, and 24 hours post-surgery, and daily at 17:00 until the 6th day post-surgery. On this scale, 0 indicates no pain, while 10 represents the worst pain the patient has ever experienced.

Secondary Outcome Measures

Name	Time	Method
Maximum mouth opening change	From the initial visit before surgery to the final visit 7 days post-surgery, at 7 days	Using a metal ruler, measure the maximum distance (in millimeters) between the incisal edge of the maxillary incisor and the lower incisor. The researcher will evaluate the maximum mouth opening at four time points: before surgery, immediately after surgery, 24 hours post-surgery, and 7 days post-surgery. The change in maximum mouth opening will be calculated by comparing the pre-surgery measurement with each subsequent measurement. Fewer changes are favorable.
Facial swelling	From the day of surgery to the last visit, at 7 days	Facial swelling is assessed using a tape-measuring method. The patient sits upright at a 90˚ angle with their mandible at rest. Three facial measurements are taken: Line A: Distance from the tragus to the corner of the mouth Line B: Distance from the tragus to the soft tissue pogonion Line C: Distance from the outer corner of the eye to the angle of the mandible The facial measurement formula is ((A + B + C) / 3). Facial swelling (%) is calculated as (\[postoperative measurement on T2 - preoperative measurement\]/preoperative measurement) \*100 Less facial swelling is favorable.

Trial Locations

Locations (1)

UCAM dental, Clinica odontologica universitaria; 🇪🇸 Murcia, Spain