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

NCT06613776 | Completed Phase 4

• 1 other identifier: CE032315
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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. 1.Do antibiotics reduce pain following third molar surgery?
2. 2.Do antibiotics influence facial swelling and the patient\'s ability to open their mouth?
3. 3.Do antibiotics affect the levels of a specific inflammatory marker in saliva post-surgery?

Conditions

Healthy; Third Molar Extraction Surgery; Antibiotic Prophylaxis; Amoxicillin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Maximum mouth opening change

  From the initial visit before surgery to the final visit 7 days post-surgery, at 7 days

• Facial swelling

  From the day of surgery to the last visit, at 7 days

Study Arms (2)

intervention group (Antibiotic)

EXPERIMENTAL

4 amoxicillin 500 mg capsules (2 grams)

Drug: Amoxicillin

Control group (Placebo)

PLACEBO COMPARATOR

4 empty amoxicillin 500mg capsules

Drug: Placebo

Interventions

Amoxicillin DRUG

4 capsules of amoxicillin 500mg, 2 grams in total, one hour before surgery

intervention group (Antibiotic)

Placebo DRUG

4 empty capsules of amoxicillin 500mg (placebo), one hour before surgery

Control group (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

UCAM dental, Clinica odontologica universitaria

Murcia, Murcia, 30008, Spain

Location

Related Publications (2)

• 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.

  PMID: 36984426 BACKGROUND

• 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.

  PMID: 23535007 BACKGROUND

MeSH Terms

Interventions

Amoxicillin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 26, 2024
• Study Start: October 5, 2023
• Primary Completion: May 27, 2024
• Study Completion: July 25, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data sharing will begin with the publication of results and will have no end date.

Locations

ES (1)