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Completed

NCT Number: 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

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.

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Key information

Conditions

Healthy Amoxicillin Antibiotic Prophylaxis Third Molar Extraction Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UCAM dental, Clinica odontologica universitaria

Murcia, 30008, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amoxicillin

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Pain reported by patients

    Time frame: 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 outcomes

  1. Maximum mouth opening change

    Time frame: 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.

  2. Facial swelling

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 26, 2024
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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