NCT04082598

Antibiotic Therapy in Erupted Tooth Extractions

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Antonio Barone · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the efficacy of amox+clav and of a probiotic after tooth extraction. the aim is to evaluate efficacy of antibiotic therapy after tooth extractions in preventing infections as compared to no therapy, and efficacy of probiotics in preventing gastro-intestinal adverse effects during the antibiotic treatment. The number of patients to be included is 150. The study products are: Amoxicillin + Clavulanic Acid and Bifidobacterium Longum and Lactoferrin.

Detailed description

The main objective of this trial is to evaluate the efficacy of the antibiotic after tooth extraction in preventing infections and to evaluate the effect of probiotic in reducing the possible antibiotic side effects. In order to analyze the effect of the antibiotic in terms of patient's general discomfort, a tailored form was prepared (Appendix A). The local signs and symptoms to evaluate are swelling, pain (assessed by the Visual Analogic Scale), presence of abscess, fever, post-extraction dental alveolitis (dry socket) and presence of trismus assessed as maximal mouth opening variation (mm). In addition adverse post-extraction events will be evaluated as follows: chewing impairments (assessed by the Visual Analogic Scale), speaking impairments (assessed by the Visual Analogic Scale), daily oral hygiene maneuvers impairments (assessed by the Visual Analogic Scale) and daily activities alterations (days-off from job/study). Moreover, the patients will be provided with a painkiller's prescription and they are required to take note of the painkillers needed during the first 7 days, i.e. until the first time point recall. The prescribed painkillers will be Ibuprofen 600 mg or naproxen sodium 500mg for those patients who reported allergy to ibuprofen. Finally, it will be a researcher duty to ask the patients if they needed to assume painkillers beyond the 7th day. Since the post-surgical sequelae depend also on the difficulty of extraction, the Appendix A provides a table in which the surgeon can take note of the type of extraction.

Conditions

• Tooth Extraction
• Post-Op Complication
• Amoxicillin

Interventions

Type	Name	Description
DRUG	Amoxicillin Clavulanate	tooth extractions are performed for all groups and antibiotics prescribed according to the allocation to the different arms
DIETARY_SUPPLEMENT	Bifidobacterium longum and Lactoferrin

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-09-30
• Completion: 2019-01-30
• First posted: 2019-09-09
• Last updated: 2020-03-11