Tooth ExtractionPhase 4NCT04082598
Antibiotic Therapy in Erupted Tooth Extractions
A Phase 4 study testing Amoxicillin Clavulanate and Bifidobacterium longum and Lactoferrin in people with Tooth Extraction and Post-Op Complication, run by Antonio Barone.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Extraction, Post-Op Complication, Amoxicillin
- What is being tested?
- Amoxicillin Clavulanate and Bifidobacterium longum and Lactoferrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 30 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who needed tooth extractions
- Patients older than 18 years
- Patients able to understand and to sign a consent form
Who cannot join
- 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
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- 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
About this study
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.
Read the 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
- Being tested
- Amoxicillin Clavulanate, Bifidobacterium longum and Lactoferrin
- Keywords
- tooth extraction, antibiotics, probiotics, tooth infection, complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin ClavulanateDrug
tooth extractions are performed for all groups and antibiotics prescribed according to the allocation to the different arms
Bifidobacterium longum and LactoferrinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Tooth extraction and antibiotic treatment | Experimental | Tooth extraction and Amoxicillin- clavulanic acid 875/125 mg, twice a day, for 6 days Receives: 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 Receives: Drug: Amoxicillin Clavulanate; Dietary Supplement: Bifidobacterium longum and Lactoferrin |
| Tooth extraction | No intervention | tooth extraction without antibiotics and/or Bifidobacterium longum and Lactoferrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of post-operative infection after tooth extractions
infection, presence or absence of pus drainage
Measured: 21 days
Rate of post-operative alveolar osteitis after tooth extractions
alveolar osteitis, presence or absence of exposed bone
Measured: 21 days
Secondary outcomes (1)
gastrointestinal symptoms
presence of abdominal pain, abdominal distension, nausea, vomit, acid reflux, gastric acidity, gastric pain, intestinal pain, gastric distension, intestinal distension and diarrhea
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start1 Oct 2016
- Primary completion30 Sep 2018
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antonio Barone
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonio Barone, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082598
- Sponsor's protocol ID
- AB0001
- Status last verified
- Mar 2020
- First submitted
- 14 Aug 2019
- Last updated
- 11 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Therapy in Erupted Tooth Extractions
- ClinicalTrials.gov ID
- NCT04082598
- Acronym / sponsor ID
- AB0001
- Conditions
- Tooth Extraction, Post-Op Complication, Amoxicillin
- Keywords
- tooth extraction, antibiotics, probiotics, tooth infection, complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Antonio BaroneUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tooth extraction and antibiotic treatment | Experimental | Drug: Amoxicillin ClavulanateTooth extraction and Amoxicillin- clavulanic acid 875/125 mg, twice a day, for 6 days |
| tooth extraction and antibiotic treatment + dietary supplement | Experimental | Drug: Amoxicillin Clavulanate, Dietary Supplement: Bifidobacterium longum and LactoferrinTooth 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 | No intervention | –tooth extraction without antibiotics and/or Bifidobacterium longum and Lactoferrin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who needed tooth extractions
- Patients older than 18 years
- Patients able to understand and to sign a consent form
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxicillin Clavulanatetooth extractions are performed for all groups and antibiotics prescribed according to the allocation to the different arms | Drug | 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 |
Primary outcome
Rate of post-operative infection after tooth extractions
Time frame: 21 days
infection, presence or absence of pus drainage
Rate of post-operative alveolar osteitis after tooth extractions
Time frame: 21 days
alveolar osteitis, presence or absence of exposed bone
1 secondary outcome
gastrointestinal symptoms
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin Clavulanate and Bifidobacterium longum and Lactoferrin in people with Tooth Extraction and Post-Op Complication, run by Antonio Barone.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of post-operative infection after tooth extractions (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.