Overview
Sponsor-declared trial summary
healthy patients
The aim of the study is to evaluate if the short-span antibiotic therapy with amoxicillin per os is not inferior compared to the long-span antibiotic prescription in favouring peri-implant tissue healing (i.e. less peri-implant bone loss), while at the same time reducing the risk of developing antimicrobial resistance.
Key facts
- Sponsor
- Universita Degli Studi Di Genova
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Stomatognathic Diseases [C07]
- Trial duration
- 2 May 2024 → ongoing
- Decision date (initial)
- 2024-04-16
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Prin 2022 PNRR Next Generation EU
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
The aim of the study is to evaluate if the short-span antibiotic therapy with amoxicillin per os is not inferior compared to the long-span antibiotic prescription in favouring peri-implant tissue healing (i.e. less peri-implant bone loss), while at the same time reducing the risk of developing antimicrobial resistance.
Conditions and MedDRA coding
healthy patients
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients requiring one single implant or partial implant-supported rehabilitation in an edentulous area of the posterior mandible or maxilla
Exclusion criteria 1
- - 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 - 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Mean bone loss
Secondary endpoints 1
- - Incidence of biological and technical complications - Implant survival rate (CSR) - Antibiotic sensitivity 1 week before and 2-6 months after implant insertion - Peri-implant myco-, microbiome and resistome 1 week before and 2-6 months after implant insertion - Salivary miRNomics 1 week before and 2 months after implant insertion - Adverse reactions - Development of a 3D bone model (sub-study) - Plaque index (PI), Bleeding on probing (BOP) and probing depth (PPD) a at 3, 6 and 12 months
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD383723 · Product
- Active substance
- Amoxicillin Trihydrate
- Substance synonyms
- AMOXYCILLIN TRIHYDRATE
- Pharmaceutical form
- TABLET
- Route of administration
- BUCCAL USE
- Max daily dose
- 3 g gram(s)
- Max total dose
- 18 g gram(s)
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CA04 — AMOXICILLIN
- Marketing authorisation
- 023086150
- MA holder
- PFIZER ITALIA S.R.L.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universita Degli Studi Di Genova
- Sponsor organisation
- Universita Degli Studi Di Genova
- Address
- Via Antonio Pastore 1
- City
- Genoa
- Postcode
- 16132
- Country
- Italy
Scientific contact point
- Organisation
- Universita Degli Studi Di Genova
- Contact name
- Maria Menini
Public contact point
- Organisation
- Universita Degli Studi Di Genova
- Contact name
- Maria Menini
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruitment ended | 80 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2024-05-02 | 2024-05-02 | 2025-12-12 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-15 | Italy | Acceptable 2024-04-15
|
2024-04-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-23 | Italy | Acceptable | 2024-06-27 |