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

Evaluation of the Effect of Antibiotic Prophylaxis on Inflammatory Factor in Salivary Samples After Third Molars Surgery

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Antibiotic Prophylaxis; Third Molar Extraction Surgery; Amoxicillin
• Intervention / Treatment: Drug: Amoxicillin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30008
    • UCAM dental, Clinica odontologica universitaria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group (Antibiotic); 4 amoxicillin 500 mg capsules (2 grams)	Drug: Amoxicillin; 4 capsules of amoxicillin 500mg, 2 grams in total, one hour before surgery
Placebo Comparator: Control group (Placebo); 4 empty amoxicillin 500mg capsules	Drug: Placebo; 4 empty capsules of amoxicillin 500mg (placebo), one hour before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain reported by patients	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.	From the first visit immediately after surgery to the last visit, 6 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum mouth opening change	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.	From the initial visit before surgery to the final visit 7 days post-surgery, at 7 days
Facial swelling	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.	From the day of surgery to the last visit, at 7 days

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2023
• Primary Completion (Actual): May 27, 2024
• Study Completion (Actual): July 25, 2024

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Amoxicillin
• Other Study ID Numbers: CE032315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data (IPD) underlying the results in a publication will be shared, ensuring the protection of patients' personal information.
• IPD Sharing Time Frame: Data sharing will begin with the publication of results and will have no end date.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No