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Study on the Effect of Amoxicillin on Post-Surgical Complications in Patients Undergoing Dental Implant Surgery with Bone Regeneration and Sinus Elevation

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What is this trial about?

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

This clinical trial is focused on patients undergoing a specific type of dental surgery known as implant surgery with guided bone regeneration and simultaneous sinus floor elevation. This procedure is often necessary for individuals who need dental implants in the upper jaw where there is insufficient bone. The study aims to evaluate the effects of using systemic antibiotics, specifically amoxicillin, compared to a placebo, on the outcomes and complications following this surgery.

Participants in the study will receive either the antibiotic Moxilen 500 mg hard capsules, which contains the active ingredient amoxicillin, or a placebo. The purpose of the study is to assess how these treatments affect patient-centered outcomes, such as the level of pain, swelling, and other discomforts experienced after the surgery. The study will monitor these outcomes over a period of time, with specific attention to the first two weeks after the surgery and then at intervals up to six months.

The study will also record any post-surgical complications, such as issues with wound healing, pain, swelling, and the stability of the dental implants. By comparing the effects of the antibiotic to the placebo, the study aims to provide valuable information on the best practices for managing recovery after this type of dental surgery.

The research process

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

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and non-smoking habits.
Participants must not have allergies to amoxicillin or related antibiotics, and must have specific dental conditions requiring implant surgery.
Step 2
Surgery preparation
Participants undergo implant surgery with guided bone regeneration and sinus floor elevation.
This procedure involves placing dental implants in areas with bone defects.
Step 3
Medication administration
Participants receive Moxilen 500 mg hard capsules containing amoxicillin to be taken orally.
The dosage and frequency are determined by the study protocol and are aimed at evaluating the effect of antibiotics on post-surgical outcomes.
Step 4
Post-surgery monitoring
Participants report their experiences using visual analogue scores (VAS) to measure symptoms such as bleeding, swelling, pain, and sinus discomfort.
These assessments occur daily from day 1 to day 7, and again on day 14.
Step 5
Follow-up assessments
Clinical evaluations are conducted at week 2, week 4, between weeks 16-20, and 6 months after the installation of the dental crown.
These assessments focus on post-surgical complications, implant stability, and any signs of infection or discomfort.

Who can join the trial?

6 criteria

Must be a medically healthy adult, classified as ASA I-II, which means having no or mild health issues.
Must be at least 21 years old.
Must be a non-smoker, a previous smoker who quit at least 5 years ago, or a light smoker who smokes less than 10 cigarettes per day.
Must not be allergic to certain antibiotics like Amoxicillin or Penicillin, pain relievers known as NSAIDs, or corn-starch.
Must have missing teeth in the back upper jaw, needing a procedure called **sinus floor elevation** and allowing for the placement of up to 3 dental implants with **guided bone regeneration (GBR)**. This is needed when the bone height is between 3-5 mm.
Must not have any signs of problems with the sinus membrane or have acute sinusitis that needs ongoing treatment.

Who cannot join the trial?

3 criteria

Patients who are not undergoing **implant surgery** with **guided bone regeneration** and **simultaneous sinus floor elevation**. This means if you are not having a specific type of dental surgery that involves adding bone and lifting the sinus, you cannot participate.
Patients who are not within the specified age range. The study is open to certain age groups, so if you are too young or too old, you may not be eligible.
Patients who are part of a vulnerable population. This means if you are in a group that needs special protection, you might not be able to join the study.

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Verified sites

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Medical University Of Graz
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Graz, Austria

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Investigated drugs

Systemic Antibiotics are medications used to treat infections by killing or stopping the growth of bacteria. In this clinical trial, they are being evaluated to see if they can reduce complications and improve outcomes for patients undergoing implant surgery with guided bone regeneration and sinus floor elevation. These antibiotics are taken by mouth or injected into the body to reach the site of surgery and help prevent or treat infections that might occur after the procedure.

Amoxicillin

What is already known about the treatment

Amoxicillin – Amoxicillin is an antibiotic that is typically administered orally in the form of tablets or capsules. It is widely used in medicine and is well-documented in medical literature as an effective treatment for bacterial infections. In the context of implant surgery with guided bone regeneration and sinus floor elevation, amoxicillin is used to prevent post-surgical infections. It works by inhibiting the synthesis of bacterial cell walls, leading to the destruction of the bacteria. Amoxicillin belongs to the pharmacological class of penicillin antibiotics.

Investigated diseases

Sinusitis – Sinusitis is an inflammation or swelling of the tissue lining the sinuses, which are air-filled spaces in the skull. It often occurs after a cold or due to allergies, leading to blocked sinuses filled with fluid where germs can grow. Symptoms include nasal congestion, a runny nose, facial pain or pressure, and a reduced sense of smell. The condition can be acute, lasting a few weeks, or chronic, persisting for several months. Sinusitis can cause discomfort and may lead to complications if not managed properly. It is commonly associated with symptoms like nosebleeds and excessive nasal discharge.