Antibiotic Therapy in Erupted Tooth Extractions

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.

Study Overview

• Status: Completed
• Conditions: Tooth Extraction; Post-Op Complication; Amoxicillin
• Intervention / Treatment: Drug: Amoxicillin Clavulanate; Dietary supplement: 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.

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who needed tooth extractions
• Patients older than 18 years
• Patients able to understand and to sign a consent form

Exclusion Criteria:

• General contraindications to oral surgery
• Third molar or impacted tooth extractions
• Patients treated or under treatment with immunosuppressive agents or patients immunocompromised
• Patients treated or under therapy with amino-bisphosphonate and anti-angiogenetic intravenous medications
• Patients who received head and neck irradiation treatments
• Patients who were diagnosed with uncontrolled diabetes
• Patients suffering from renal failure
• Pregnancy and breastfeeding patients
• Patients diagnosed with drug and alcohol addiction
• Patients who suffer from psychiatric disorders
• Patients diagnosed with allergy to penicillin and probiotic

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tooth extraction and antibiotic treatment; Tooth extraction and Amoxicillin- clavulanic acid 875/125 mg, twice a day, for 6 days	Drug: Amoxicillin Clavulanate; tooth extractions are performed for all groups and antibiotics prescribed according to the allocation to the different arms
Experimental: tooth extraction and antibiotic treatment + dietary supplement; Tooth extraction and Amoxicillin- clavulanic acid 875/125 mg, twice a day, for 6 days + Bifidobacterium longum and Lactoferrin twice a day for 6days	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
No Intervention: Tooth extraction; tooth extraction without antibiotics and/or Bifidobacterium longum and Lactoferrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of post-operative infection after tooth extractions	infection, presence or absence of pus drainage	21 days
Rate of post-operative alveolar osteitis after tooth extractions	alveolar osteitis, presence or absence of exposed bone	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gastrointestinal symptoms	presence of abdominal pain, abdominal distension, nausea, vomit, acid reflux, gastric acidity, gastric pain, intestinal pain, gastric distension, intestinal distension and diarrhea	21 days

Collaborators and Investigators

• Sponsor: Antonio Barone

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): January 30, 2019

Study Registration Dates

• First Submitted: August 14, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 7, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: complications; probiotics; antibiotics; tooth extraction; tooth infection
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination; Lactoferrin
• Other Study ID Numbers: AB0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No