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
About this trial
This is an interventional treatment trial for Tooth Extraction focused on measuring tooth extraction, antibiotics, probiotics, tooth infection, complications
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
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
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
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Antibiotic Therapy in Erupted Tooth Extractions
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