Antibiotic Therapy in Erupted Tooth Extractions

NCT04082598 | Completed Phase 4

• 1 other identifier: AB0001
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tooth Extraction; Post-Op Complication; Amoxicillin

Keywords

tooth extraction; antibiotics; probiotics; tooth infection; complications

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• gastrointestinal symptoms

  21 days

Study Arms (3)

Tooth extraction and antibiotic treatment

EXPERIMENTAL

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

Drug: Amoxicillin Clavulanate

tooth extraction and antibiotic treatment + dietary supplement

EXPERIMENTAL

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; Dietary Supplement: Bifidobacterium longum and Lactoferrin

Tooth extraction

NO INTERVENTION

tooth extraction without antibiotics and/or Bifidobacterium longum and Lactoferrin

Interventions

Amoxicillin Clavulanate DRUG

tooth extractions are performed for all groups and antibiotics prescribed according to the allocation to the different arms

Tooth extraction and antibiotic treatment; tooth extraction and antibiotic treatment + dietary supplement

Bifidobacterium longum and Lactoferrin DIETARY_SUPPLEMENT

tooth extraction and antibiotic treatment + dietary supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Antonio Barone: lead

MeSH Terms

Conditions

Postoperative Complications

Interventions

Amoxicillin-Potassium Clavulanate Combination; Lactoferrin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor ( DDS, PhD, MSc)

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: September 9, 2019
• Study Start: October 1, 2016
• Primary Completion: September 30, 2018
• Study Completion: January 30, 2019
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share