The Effect of Different Antibiotic Protocols on Peri-implant Tissue Health

NCT06378502 | Not Yet Recruiting Phase 4

• 1 other identifier: antibiotic-resistence
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Antibiotic

Outcome Measures

Primary Outcomes (1)

• Mean peri-implant bone loss

  bone loss

  at 6 and 12 months after prosthesis delivery

Secondary Outcomes (10)

• Incidence of biological and technical complications at the implant site

  12 months

• implant survival rate

  12 months

• Antibiotic sensitivity

  1 week before and 2 months and 6 months after implant insertion

• Peri-implant myco-, microbiome and resistome

  1 week before and 2 months and 6 months after implant insertion

• Salivary miRNomics

  1 week before and 2 months after implant insertion

Study Arms (2)

Long-span therapy

EXPERIMENTAL

1 g Amoxicillin every 8 h starting 1 day before surgery and for 5 days after surgery

Drug: Amoxicillin Long

Short-span therapy

EXPERIMENTAL

2 g Amoxicillin 1 h before surgery

Drug: Amoxicillin Short

Interventions

Amoxicillin Short DRUG

Short Span

Short-span therapy

Amoxicillin Long DRUG

Long span

Long-span therapy

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers requiring one single implant or partial implant-supported rehabilitation in an edentulous area of the posterior mandible or maxilla

You may not qualify if:

• 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

Sponsors & Collaborators

• Universita degli Studi di Genova: lead

Central Study Contacts

Maria Menini

CONTACT

3396598789‬; maria.menini@unige.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: May 3, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 22, 2024

Record last verified: 2024-04