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A Study of Short-term vs Long-term Amoxicillin Treatment in Healthy Patients Undergoing Dental Implant Surgery: Effects on Peri-implant Tissue Health

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study examines the effects of different antibiotic treatments during dental implant surgery. The research focuses on how these treatments affect the health of tissues around the implant and the natural bacteria in the mouth. The medication used in the study is amoxicillin, which is taken by mouth.

The purpose of this research is to determine if a shorter course of antibiotics works as well as a longer course in helping the tissues around dental implants heal properly. The study will specifically look at bone loss around the implants and track how the treatment affects bacteria in the mouth. Participants will receive dental implants in the back area of their upper or lower jaw.

During the study, patients will take amoxicillin tablets according to their assigned treatment schedule. The research will monitor the healing of the areas around the implants and examine various aspects of oral health. This includes checking the condition of the tissues around the implants, measuring bone levels, and studying the types of bacteria present in the mouth before and after the implant procedure.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial dental implant surgery

    You will receive a dental implant in the back area of your upper or lower jaw

    The procedure involves placing a single implant or partial implant-supported rehabilitation

  2. Step 2

    Antibiotic treatment

    You will be prescribed ZIMOX tablets containing amoxicillin

    The medication will be taken by mouth

    You will follow one of the prescribed antibiotic protocols - either short-term or long-term treatment

  3. Step 3

    Initial follow-up examination

    A sample will be taken to check for antibiotic sensitivity 1 week before and 2-6 months after implant placement

    Additional samples will be collected to analyze the bacteria and microorganisms around the implant

  4. Step 4

    Regular check-ups

    Your implant will be examined at 3, 6, and 12 months after placement

    During these visits, the following will be checked:

    - Amount of dental plaque (plaque index)

    - Bleeding around the implant (bleeding on probing)

    - Depth of the space between the implant and gum (probing depth)

    - Any complications or adverse reactions will be documented

  5. Step 5

    Bone loss measurement

    Throughout the study, the amount of bone loss around your implant will be monitored

    This measurement helps determine how well the implant is integrating with your jaw bone

Who can join the trial?

9 criteria

  • Must be a healthy adult (18 years or older)
  • Can be either male or female
  • Must need a dental implant in one of these areas:
    • Back area of upper jaw (posterior maxilla)
    • Back area of lower jaw (posterior mandible)
    • Must need either:
      • A single dental implant, or
      • Multiple implants to support partial tooth replacement
      • Must be missing teeth in the treatment area (edentulous area)
      • Must not belong to any vulnerable population groups
      • Must be able to take oral antibiotics (amoxicillin)

Who cannot join the trial?

12 criteria

  • Patients who are allergic to amoxicillin or other penicillin antibiotics
  • Patients with active infections or ongoing medical treatments that could interfere with the study
  • Individuals with compromised immune systems (weakened ability to fight infections)
  • Patients with uncontrolled diabetes (consistently high blood sugar levels)
  • Those with a history of chronic bone diseases that could affect healing
  • Patients currently taking medications that could interact with amoxicillin
  • Individuals who have received antibiotics within the past month
  • Patients with severe kidney or liver problems that could affect medication processing
  • Those with a history of alcohol or drug abuse
  • Pregnant or breastfeeding women
  • Patients who have participated in another clinical trial within the past 30 days
  • Individuals unable to follow the study protocol or attend follow-up visits
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Investigated drugs

Amoxicillin is an oral antibiotic medication that belongs to the penicillin group. It works by stopping the growth of bacteria and is commonly used in dental procedures. In this trial, it is being studied to prevent infections after dental implant surgery and promote proper healing of the tissues around the implant. The medication helps protect the area where the dental implant is placed while the bone and gums heal.

What is already known about the treatment

Amoxicillin - An oral antibiotic medication belonging to the penicillin group that is widely used in dental and medical practice. This broad-spectrum antibiotic works by interfering with bacterial cell wall synthesis, effectively stopping the growth and multiplication of bacteria. It is commonly prescribed for dental implant surgery to prevent post-operative infections and promote proper healing of peri-implant tissues, with different protocols exploring various durations of treatment to balance therapeutic effectiveness with the risk of antimicrobial resistance. The medication comes in oral form as capsules or tablets and is typically taken every 8 hours with or without food.

Investigated diseases

  • Peri-implantitis

    A progressive inflammatory condition affecting the soft and hard tissues surrounding dental implants. The condition develops when bacteria accumulate around the implant, leading to inflammation of the surrounding gum tissue and gradual loss of supporting bone. It typically begins with redness and swelling of the gum tissue around the implant, followed by deepening of the space between the implant and the gum. The process can cause the implant to become loose over time if not addressed.

  • Bone Loss (Dental)

    A condition where bone tissue around teeth or dental implants gradually diminishes in volume and density. The process can occur due to various factors, including inflammatory responses, mechanical stress, or natural remodeling processes. The bone loss typically progresses from the top of the bone downward, potentially affecting the stability of dental implants or natural teeth.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510391-31-00Estimated enrolment80 patientsSponsorUniversita' Degli Studi Di Genova

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