Clinical trial • Not applicable • Other

Amoxicillin trihydrate for Peri-implant disease | Oral microbiome alterations

Not applicable trial of Amoxicillin trihydrate for Peri-implant disease | Oral microbiome alterations.

Overview

Trial Therapeutic Area
Other
Trial Disease
Peri-implant disease | Oral microbiome alterations
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
15-12-2023
First CTIS Authorization Date
16-04-2024

Trial design

Short-span oral amoxicillin regimen versus long-span oral amoxicillin regimen (amoxicillin trihydrate; product: ZIMOX 1 g compresse). Dose and detailed schedule not specified in the record.-controlled Not applicable trial across 1 site in Italy.

Comparator
Short-span oral amoxicillin regimen versus long-span oral amoxicillin regimen (amoxicillin trihydrate; product: ZIMOX 1 g compresse). Dose and detailed schedule not specified in the record.
Target Sample Size
80
Trial Duration For Participant
365

Eligibility

Recruits 80 No vulnerable populations selected (isVulnerablePopulationSelected: false). No specific consent/assent handling for vulnerable groups is described in the record..

Pregnancy Exclusion
Pregnancy, childbearing potential, breastfeeding
Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). No specific consent/assent handling for vulnerable groups is described in the record.

Inclusion criteria

  • {"criterion_text":"- Patients requiring one single implant or partial implant-supported rehabilitation in an edentulous area of the posterior mandible or maxilla"}

Exclusion criteria

  • {"criterion_text":"- Patients unable to commit to follow-up"}
  • {"criterion_text":"- General contraindications to implant surgery"}
  • {"criterion_text":"- Immuno-suppressed/immune-compromised patients"}
  • {"criterion_text":"- Patients irradiated in the head and/or neck"}
  • {"criterion_text":"- Uncontrolled diabetes"}
  • {"criterion_text":"- Pregnancy, childbearing potential, breastfeeding"}
  • {"criterion_text":"- Smoking habit"}
  • {"criterion_text":"- Untreated periodontal disease (Caton et al, J Clin Periodontol 2018)"}
  • {"criterion_text":"- Poor oral hygiene and motivation (plaque index > 20%)"}
  • {"criterion_text":"- Addiction to alcohol or drugs"}
  • {"criterion_text":"- Psychiatric problems and/or unrealistic expectations"}
  • {"criterion_text":"- Patients with an acute infection (abscess) or suppuration in the site intended for implant placement"}
  • {"criterion_text":"- Patients treated or under treatment with intravenous amino-bisphosphonates"}
  • {"criterion_text":"- Patients referred only for implant placement if the follow-up cannot be done at the treatment center"}
  • {"criterion_text":"- Patients participating in other studies, if the present protocol could not be fully adhered to"}
  • {"criterion_text":"- Patients with allergy/hypersensitivity to penicillin or drug excipients"}
  • {"criterion_text":"- Patients recently treated with antibiotics for other indications"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Mean bone loss","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Incidence of biological and technical complications","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Implant survival rate (CSR)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Antibiotic sensitivity 1 week before and 2-6 months after implant insertion","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Peri-implant myco-, microbiome and resistome 1 week before and 2-6 months after implant insertion","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Salivary miRNomics 1 week before and 2 months after implant insertion","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Adverse reactions","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Development of a 3D bone model (sub-study)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Plaque index (PI), Bleeding on probing (BOP) and probing depth (PPD) a at 3, 6 and 12 months","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
80
Recruitment Window Months
21

Geography

Total Number Of Sites
1
Total Number Of Participants
80

Italy

Earliest CTIS Part Ii Submission Date
19-03-2024
Latest Decision Or Authorization Date
27-06-2024
Processing Time Days
100
Number Of Sites
1
Number Of Participants
80

Sites

Site Name
Universita Degli Studi Di Genova
Department Name
DISC
Principal Investigator Name
Maria Menini
Principal Investigator Email
maria.menini@unige.it
Contact Person Name
Maria Menini
Contact Person Email
maria.menini@unige.it
Number Of Participants
80

Sponsor

Primary sponsor

Full Name
Universita Degli Studi Di Genova
Organisation Type
Educational Institution
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
ZIMOX 1 g compresse
Active Substance
Amoxicillin trihydrate
Modality
Small molecule
Routes Of Administration
Oral (per os)|Buccal use
Route
Oral (per os)
Authorisation Status
Authorised (marketing authorisation number 023086150, authorisationCountryCode: IT)
Dose Levels
Not specified; product information: 1 g tablets; max daily dose 3 g; max total dose 18 g
Maximum Dose
3 g per day

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