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Antibiotic Therapy in Erupted Tooth Extractions

Primary Purpose

Tooth Extraction, Post-Op Complication, Amoxicillin

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Amoxicillin Clavulanate
Bifidobacterium longum and Lactoferrin
Sponsored by
Antonio Barone
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Extraction focused on measuring tooth extraction, antibiotics, probiotics, tooth infection, complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Tooth extraction and antibiotic treatment

    tooth extraction and antibiotic treatment + dietary supplement

    Tooth extraction

    Arm Description

    Tooth extraction and Amoxicillin- clavulanic acid 875/125 mg, twice a day, for 6 days

    Tooth extraction and Amoxicillin- clavulanic acid 875/125 mg, twice a day, for 6 days + Bifidobacterium longum and Lactoferrin twice a day for 6days

    tooth extraction without antibiotics and/or Bifidobacterium longum and Lactoferrin

    Outcomes

    Primary Outcome Measures

    Rate of post-operative infection after tooth extractions
    infection, presence or absence of pus drainage
    Rate of post-operative alveolar osteitis after tooth extractions
    alveolar osteitis, presence or absence of exposed bone

    Secondary Outcome Measures

    gastrointestinal symptoms
    presence of abdominal pain, abdominal distension, nausea, vomit, acid reflux, gastric acidity, gastric pain, intestinal pain, gastric distension, intestinal distension and diarrhea

    Full Information

    First Posted
    August 14, 2019
    Last Updated
    March 7, 2020
    Sponsor
    Antonio Barone
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04082598
    Brief Title
    Antibiotic Therapy in Erupted Tooth Extractions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2016 (Actual)
    Primary Completion Date
    September 30, 2018 (Actual)
    Study Completion Date
    January 30, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Antonio Barone

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Extraction, Post-Op Complication, Amoxicillin
    Keywords
    tooth extraction, antibiotics, probiotics, tooth infection, complications

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    165 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tooth extraction and antibiotic treatment
    Arm Type
    Experimental
    Arm Description
    Tooth extraction and Amoxicillin- clavulanic acid 875/125 mg, twice a day, for 6 days
    Arm Title
    tooth extraction and antibiotic treatment + dietary supplement
    Arm Type
    Experimental
    Arm Description
    Tooth extraction and Amoxicillin- clavulanic acid 875/125 mg, twice a day, for 6 days + Bifidobacterium longum and Lactoferrin twice a day for 6days
    Arm Title
    Tooth extraction
    Arm Type
    No Intervention
    Arm Description
    tooth extraction without antibiotics and/or Bifidobacterium longum and Lactoferrin
    Intervention Type
    Drug
    Intervention Name(s)
    Amoxicillin Clavulanate
    Intervention Description
    tooth extractions are performed for all groups and antibiotics prescribed according to the allocation to the different arms
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Bifidobacterium longum and Lactoferrin
    Primary Outcome Measure Information:
    Title
    Rate of post-operative infection after tooth extractions
    Description
    infection, presence or absence of pus drainage
    Time Frame
    21 days
    Title
    Rate of post-operative alveolar osteitis after tooth extractions
    Description
    alveolar osteitis, presence or absence of exposed bone
    Time Frame
    21 days
    Secondary Outcome Measure Information:
    Title
    gastrointestinal symptoms
    Description
    presence of abdominal pain, abdominal distension, nausea, vomit, acid reflux, gastric acidity, gastric pain, intestinal pain, gastric distension, intestinal distension and diarrhea
    Time Frame
    21 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Antibiotic Therapy in Erupted Tooth Extractions

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