Evaluation of the effectiveness of the antibiotic therapy in preventing complications after tooth extraction and evaluation of the effectiveness of the probiotic in preventing antibiotic adverse effect

Phase 1

• Conditions: teeth needing extraction due to infections; MedDRA version: 21.1Level: PTClassification code 10062132Term: Tooth extractionSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: PTClassification code 10044034Term: Tooth disorderSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2016-001916-39-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

- Female and male patients seeking Oral Dental Care at UO Odontostomatologia e Chirurgia del Cavo Orale” and needing dental extractions due to an ongoing infection.
- Adult patients (=18 year old)
- Subjects capable of giving informed consent
- Subjects who are women of childbearing potential must agree to utilize a highly effective contraceptive measure throughout the course of the study for the entire duration of the trial and the subsequent 60-day follow-up

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

- Patients requiring third molar extractions
- General contraindications to oral surgery
- Immunosuppressed or immunocompromised patients
- Patients under therapy with aminobisphosphonates i.v
- Head and neck irradiation
- Pregnancy and breastfeeding
- Uncontrolled diabetes
- Patients suffering from infectious mononucleosis
- Patients suffering from colitis
- Patients suffering from renal failure
- Patients having drug and alcohol dependence
- Psychiatric disorders that contraindicate oral surgery
- Allergy both to penicillin, or other beta-lactams, and probiotic
- Hypersensitivity to active ingredient and to all penicillins
- History of severe immediate hypersensitivity reactions (e.g. anaphylaxis) to other beta-lactam agents (e.g. cephalosporins, carbapenems, monobactams)
- Patients under therapy with methotrexate, probenecid, mycophenolate mofetil, allopurinol
- Patients with history of amox+clav-related jaundice/hepatic failure
- Patients with hyper-sensibility to stearate magnesium, sodium carboxymethylamid A, silica colloidal anhydrous, microcrystal cellulose, titanium dioxide (E171), hypromellose, Macrogol (4000-6000) and dimethicone;
- Patients under therapy with oral anticoagulants;
- Hypersensitivity to all excipients/substances in the probiotic

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified