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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Unmlvyedmzbkcofrr Dtuvg Suizy Dn Gkbatq	Genoa	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	02.04.2024

Trial locations

Investigated drugs:

Amoxicillin Trihydrate

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.

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 ID:

2023-510391-31-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?