Antibiotic Therapy in Erupted Tooth Extractions

NCT ID: NCT04082598

Last Updated: 2020-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2019-01-30

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.

Conditions

Tooth Extraction; Post-Op Complication; Amoxicillin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tooth extraction and antibiotic treatment

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

Group Type: EXPERIMENTAL

Amoxicillin Clavulanate

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Amoxicillin Clavulanate

Intervention Type: DRUG

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

Bifidobacterium longum and Lactoferrin

Intervention Type: DIETARY_SUPPLEMENT

Tooth extraction

tooth extraction without antibiotics and/or Bifidobacterium longum and Lactoferrin

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Amoxicillin Clavulanate

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

Intervention Type: DRUG

Bifidobacterium longum and Lactoferrin

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antonio Barone

OTHER

Sponsor Role: lead

Responsible Party

Antonio Barone

Associate Professor ( DDS, PhD, MSc)

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

AB0001

Identifier Type: -

Identifier Source: org_study_id