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

A phase IV, single-blind, randomized, controlled, single-center study evaluating the efficacy of amoxicillin+clavulanic acid Vs no treatment in preventing complications after tooth extraction and the efficacy of a probiotic in preventing antibiotic adverse effect - AB0001

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001916-39-IT

Enrollment

150

Registered

2021-06-08

Start date

2016-09-09

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

teeth needing extraction due to infections MedDRA version: 21.1 Level: PT Classification code 10062132 Term: Tooth extraction System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: PT Classification code 10044034 Term: Tooth disorder System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: NEODUPLAMOX - 875 MG/125 MG COMPRESSE RIVESTITE CON FILM 12 COMPRESSE Product Name: NEODUPLAMOX Product Code: NEODUPLAMOX Pharmaceutical Form: Film-coated tablet INN or Proposed INN: AMOXI

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate whether antibiotic therapy could reduce post-surgical complications after tooth extractions due to a dental infection as compared to no-treatment group by which we want to evaluate whether the extraction alone is sufficient to resolve the infection leading to tooth extraction. Besides, it will be important also to understand whether probiotic could be beneficial for the patients in reducing gastro-intestinal side effects of the antibiotics;Secondary Objective: To describe demographically the population requiring Hospital Dental Care and to understand what are the main reasons for tooth extractions in order to set up tailored dental health programs;Primary end point(s): 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) ;Timepoint(s) of evaluation of this end point: T1- 7 after the tooth extraction; T2- 14 days after the tooth extraction; T3- 21 days after the tooth extraction	—

Measure

Time frame

Main Objective: To evaluate whether antibiotic therapy could reduce post-surgical complications after tooth extractions due to a dental infection as compared to no-treatment group by which we want to evaluate whether the extraction alone is sufficient to resolve the infection leading to tooth extraction. Besides, it will be important also to understand whether probiotic could be beneficial for the patients in reducing gastro-intestinal side effects of the antibiotics;Secondary Objective: To describe demographically the population requiring Hospital Dental Care and to understand what are the main reasons for tooth extractions in order to set up tailored dental health programs;Primary end point(s): 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) ;Timepoint(s) of evaluation of this end point: T1- 7 after the tooth extraction; T2- 14 days after the tooth extraction; T3- 21 days after the tooth extraction

—

Secondary

Measure	Time frame
Secondary end point(s): Besides the main objectives, we could describe demographically the population seeking oral dental care at UO Odontostomatologia e Chirurgia del Cavo Orale. Moreover, it will be possible to understand the main reason for tooth extraction in the population coming to the Hospital;Timepoint(s) of evaluation of this end point: T0 (extraction)	—

Countries

Italy

Contacts

Public ContactU.O. Odontostomatologia e Chirurgia

U.O. Odontostomatologia e Chirurgia del Cavo Orale

antonio.barone@unipi.it050992628

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026