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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group (Antibiotic) | Experimental | 4 amoxicillin 500 mg capsules (2 grams) |
|
| Control group (Placebo) | Placebo Comparator | 4 empty amoxicillin 500mg capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin | Drug | 4 capsules of amoxicillin 500mg, 2 grams in total, one hour before surgery |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCAM dental, Clinica odontologica universitaria | Murcia | Murcia | 30008 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36984426 | Background | 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. | |
| 23535007 | 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. |
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All individual participant data (IPD) underlying the results in a publication will be shared, ensuring the protection of patients' personal information.
Data sharing will begin with the publication of results and will have no end date.
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| Placebo | Drug | 4 empty capsules of amoxicillin 500mg (placebo), one hour before surgery |
|
| 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 |
| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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