AntibioticPhase 4NCT06378502
The Effect of Different Antibiotic Protocols on Peri-implant Tissue Health
A Phase 4 study testing Amoxicillin Short and Amoxicillin Long in people with Antibiotic, run by Universita degli Studi di Genova.
Trial summary
The aim of the present project (non-inferiority trial) is to evaluate the effect of different antibiotic strategies (long-span vs. short-span) for implant surgery on peri-implant tissue health, oral microbiome (included resistome) and salivary MiRNomics in healthy patients. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Antibiotic
- What is being tested?
- Amoxicillin Short and Amoxicillin Long
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 3 May 2024to 30 Jun 2026
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers requiring one single implant or partial implant-supported rehabilitation in an edentulous area of the posterior mandible or maxilla
Who cannot join
- Patients unable to commit to follow-up
- General contraindications to implant surgery
- Immuno-suppressed/immune-compromised patients
- Patients irradiated in the head and/or neck
- Uncontrolled diabetes
- Pregnancy, childbearing potential, breastfeeding
Show all 17Show fewer
- Smoking habit
- Untreated periodontal disease (Caton et al, J Clin Periodontol 2018)
- Poor oral hygiene and motivation (plaque index > 20%)
- Addiction to alcohol or drugs
- Psychiatric problems and/or unrealistic expectations
- Patients with an acute infection (abscess) or suppuration in the site intended for implant placement
- Patients treated or under treatment with intravenous amino-bisphosphonates
- Patients referred only for implant placement if the follow-up cannot be done at the treatment center
- Patients participating in other studies, if the present protocol could not be fully adhered to
- Patients with allergy/hypersensitivity to penicillin or drug excipients
- Patients recently treated with antibiotics for other indications
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Different Antibiotic Protocols for Dental Implant Surgery on Peri-implant Tissue Health and on Oral Microbiome and Resistome
The aim of the present project (non-inferiority trial) is to evaluate the effect of different antibiotic strategies (long-span vs. short-span) for implant surgery on peri-implant tissue health, oral microbiome (included resistome) and salivary MiRNomics in healthy patients.
Read the detailed description
A total of 80 patients will be included and randomly divided in two groups:
- Long-span prescription: 1 g Amoxicillin every 8 h starting 1 day before surgery and for 5 days after surgery
- Short-span prescription: 2 g Amoxicillin 1 h before surgery Before surgery, patients will undergo an antibiotic sensitivity test (AST), and non-invasive samples will be taken to analyse oral microbiome including resistome. Saliva samples will be also taken for miRNomics analysis. Patients will be rehabilitated with single implants or partial implant-supported fixed prostheses. The day of surgery, samples of peripheral blood will be taken and peripheral blood mononuclear cells (PBMCs) isolated from the first 30 patients in order to implement a micro-fluidic bioreactor replicating the bone healing process of each patient. 3D bone models will be developed that are suitable for drug screening.
At 2 and 6 months post-treatment, AST test and oral microbiome and resistome analysis will be performed again. 2 months after treatment, a new saliva sample of the patients will be also taken, analysed and compared using MiRnomics technology with the preoperative one with the further aim of identifying reliable biomarkers of mucositis and perimplantitis. During the 12-month follow-up implant survival rate, marginal bone loss (MBL), biologic and technical complication rate and peri-implant health parameters (including plaque index, probing depth and bleeding on probing) will be evaluated.
Parametric or non-parametric comparative tests, as appropriate, will be performed to detect differences between the groups in the various outcome variables. The effect of patient-related and implant-related predictive factors on the various outcomes will be evaluated using multilevel logistic regression analysis. Metadata will be analyzed also with 4th generation Artificial Neural Networks (ANNs) (machine learning) using unsupervised and supervised systems.
Expected results: The present project is expected to clarify if the short-span antibiotic therapy is not inferior to the long-span one in healthy patients undergoing implant surgery. The outcomes will contribute to the development of effective clinical guidelines that will help to tackle the issue of antimicrobial resistance. In addition, the development and validation of a 3D bone model to be used for drug screening is expected, that might overcome limitations of currently available 2D bone models and animal studies. A further expected result is the identification of biomarkers for diagnosis and prognosis in implant dentistry, through salivary miRNomics that might lead to the development of a non-invasive liquid biopsy.
- Conditions
- Antibiotic
- Being tested
- Amoxicillin Short, Amoxicillin Long
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin ShortDrug
Short Span
Amoxicillin LongDrug
Long span
| Study group | Role | What they receive |
|---|---|---|
| Long-span therapy | Experimental | 1 g Amoxicillin every 8 h starting 1 day before surgery and for 5 days after surgery Receives: Drug: Amoxicillin Long |
| Short-span therapy | Experimental | 2 g Amoxicillin 1 h before surgery Receives: Drug: Amoxicillin Short |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean peri-implant bone loss
bone loss
Measured: at 6 and 12 months after prosthesis delivery
Secondary outcomes (10)
Incidence of biological and technical complications at the implant site
complications
Measured: 12 months
implant survival rate
CSR
Measured: 12 months
Antibiotic sensitivity
sensitivity
Measured: 1 week before and 2 months and 6 months after implant insertion
Peri-implant myco-, microbiome and resistome
resistome
Measured: 1 week before and 2 months and 6 months after implant insertion
Salivary miRNomics
miRNomics
Measured: 1 week before and 2 months after implant insertion
Adverse reactions
reaction
Measured: during the entire follow-up period
Development of a 3D bone model
3D bone model
Measured: 1 year
Plaque index (PI)
measured on 6 surfaces each tooth - percentage value
Measured: 3, 6 and 12 months after prosthesis delivery
Bleeding on probing (BOP)
measured on 6 surfaces each tooth - percentage value
Measured: 3, 6 and 12 months after prosthesis delivery
Peri-implant pocket probing depth (PPD)
measured on 6 surfaces each tooth - percentage value
Measured: 3, 6 and 12 months after prosthesis delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start3 May 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AntibioticStudies 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita degli Studi di Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Menini, Universita degli Studi di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378502
- Sponsor's protocol ID
- antibiotic-resistence
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Antibiotic Protocols for Dental Implant Surgery on Peri-implant Tissue Health and on Oral Microbiome and Resistome
- ClinicalTrials.gov ID
- NCT06378502
- Acronym / sponsor ID
- antibiotic-resistence
- Conditions
- Antibiotic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universita degli Studi di GenovaUniversity, hospital or other
- Study start
- 3 May 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 22 Apr 2024 (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.
The aim of the present project (non-inferiority trial) is to evaluate the effect of different antibiotic strategies (long-span vs. short-span) for implant surgery on peri-implant tissue health, oral microbiome (included resistome) and salivary MiRNomics in healthy patients.
Detailed description
A total of 80 patients will be included and randomly divided in two groups:
- Long-span prescription: 1 g Amoxicillin every 8 h starting 1 day before surgery and for 5 days after surgery
- Short-span prescription: 2 g Amoxicillin 1 h before surgery Before surgery, patients will undergo an antibiotic sensitivity test (AST), and non-invasive samples will be taken to analyse oral microbiome including resistome. Saliva samples will be also taken for miRNomics analysis. Patients will be rehabilitated with single implants or partial implant-supported fixed prostheses. The day of surgery, samples of peripheral blood will be taken and peripheral blood mononuclear cells (PBMCs) isolated from the first 30 patients in order to implement a micro-fluidic bioreactor replicating the bone healing process of each patient. 3D bone models will be developed that are suitable for drug screening.
At 2 and 6 months post-treatment, AST test and oral microbiome and resistome analysis will be performed again. 2 months after treatment, a new saliva sample of the patients will be also taken, analysed and compared using MiRnomics technology with the preoperative one with the further aim of identifying reliable biomarkers of mucositis and perimplantitis. During the 12-month follow-up implant survival rate, marginal bone loss (MBL), biologic and technical complication rate and peri-implant health parameters (including plaque index, probing depth and bleeding on probing) will be evaluated.
Parametric or non-parametric comparative tests, as appropriate, will be performed to detect differences between the groups in the various outcome variables. The effect of patient-related and implant-related predictive factors on the various outcomes will be evaluated using multilevel logistic regression analysis. Metadata will be analyzed also with 4th generation Artificial Neural Networks (ANNs) (machine learning) using unsupervised and supervised systems.
Expected results: The present project is expected to clarify if the short-span antibiotic therapy is not inferior to the long-span one in healthy patients undergoing implant surgery. The outcomes will contribute to the development of effective clinical guidelines that will help to tackle the issue of antimicrobial resistance. In addition, the development and validation of a 3D bone model to be used for drug screening is expected, that might overcome limitations of currently available 2D bone models and animal studies. A further expected result is the identification of biomarkers for diagnosis and prognosis in implant dentistry, through salivary miRNomics that might lead to the development of a non-invasive liquid biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long-span therapy | Experimental | Drug: Amoxicillin Long1 g Amoxicillin every 8 h starting 1 day before surgery and for 5 days after surgery |
| Short-span therapy | Experimental | Drug: Amoxicillin Short2 g Amoxicillin 1 h before surgery |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers requiring one single implant or partial implant-supported rehabilitation in an edentulous area of the posterior mandible or maxilla
Key exclusion criteria (17 listed)
- Patients unable to commit to follow-up
- General contraindications to implant surgery
- Immuno-suppressed/immune-compromised patients
- Patients irradiated in the head and/or neck
- Uncontrolled diabetes
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 ShortShort Span | Drug | Short-span therapy |
| Amoxicillin LongLong span | Drug | Long-span therapy |
Primary outcome
Mean peri-implant bone loss
Time frame: at 6 and 12 months after prosthesis delivery
bone loss
10 secondary outcomes
Incidence of biological and technical complications at the implant site
Time frame: 12 months
implant survival rate
Time frame: 12 months
Antibiotic sensitivity
Time frame: 1 week before and 2 months and 6 months after implant insertion
Peri-implant myco-, microbiome and resistome
Time frame: 1 week before and 2 months and 6 months after implant insertion
Salivary miRNomics
Time frame: 1 week before and 2 months after implant insertion
Adverse reactions
Time frame: during the entire follow-up period
Development of a 3D bone model
Time frame: 1 year
Plaque index (PI)
Time frame: 3, 6 and 12 months after prosthesis delivery
Bleeding on probing (BOP)
Time frame: 3, 6 and 12 months after prosthesis delivery
Peri-implant pocket probing depth (PPD)
Time frame: 3, 6 and 12 months after prosthesis delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin Short and Amoxicillin Long in people with Antibiotic, run by Universita degli Studi di Genova.
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 1 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 22 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Menini (3396598789, maria.menini@unige.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean peri-implant bone loss (time frame: at 6 and 12 months after prosthesis delivery). 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 22 Apr 2024.