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Study on the Effects of Amoxicillin on Post-Surgical Complications in Patients with Tooth Loss Undergoing Implant Surgery

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 clinical trial is focused on studying the effects of a medication called amoxicillin on patients who are undergoing a specific type of dental surgery. The surgery involves placing dental implants in the upper back part of the mouth, where there is a need to increase bone height due to a condition known as edentulism. This condition means that there are missing teeth, and the bone in that area has decreased in height, requiring additional procedures to support the implants.

The purpose of the study is to evaluate how taking amoxicillin, a type of antibiotic, affects the healing process and any complications that might occur after the surgery. The surgery includes two main procedures: guided bone regeneration, which helps to rebuild the bone, and sinus floor elevation, which involves lifting the sinus membrane to make room for the bone graft. The study will compare the outcomes of patients who take amoxicillin with those who do not, to see if the antibiotic helps reduce complications such as pain, swelling, and other discomforts.

Participants in the study will be monitored for any post-surgical issues, such as how well the surgical site heals and whether there are any signs of infection or implant problems. The study aims to gather information on how patients feel after the surgery, including any pain or discomfort they experience, to better understand the benefits of using amoxicillin in these dental procedures.

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
Initial consultation
The initial consultation involves a detailed assessment to confirm eligibility for the trial. This includes verifying that the patient is a medically healthy adult, aged 21 or older, and meets specific health criteria such as being a non-smoker or a light smoker.
The patient must not have allergies to amoxicillin, penicillin antibiotics, NSAIDs (non-steroidal anti-inflammatory drugs), or cornstarch. The patient should have edentulous spaces in the posterior maxilla requiring sinus floor elevation and implant placement.
Step 2
Surgical procedure
The surgical procedure involves oral implant therapy with simultaneous lateral approach sinus floor elevation and guided bone regeneration. This is performed to address the bone height defect and allow for the placement of up to three dental implants.
Step 3
Medication administration
Following the surgical procedure, the patient will be administered amoxicillin in the form of 500 mg hard capsules. The medication is taken orally to help prevent post-surgical complications.
The dosage and frequency of amoxicillin administration will be determined by the healthcare provider based on the patient's specific needs and the trial protocol.
Step 4
Post-surgical monitoring
The patient will be monitored for post-surgical complications. This includes assessing the wound for pain, swelling, bruising, and bleeding, as well as any discomfort in the sinuses such as nosebleeds or nasal congestion.
Patient-reported outcome measures (PROMs) will be collected using visual analogue scores (VAS) to evaluate the patient's experience of these symptoms.
Step 5
Follow-up assessments
Regular follow-up assessments will be conducted to record any clinical signs of post-surgical complications, such as flap closure issues, purulent discharge, swelling, implant stability, and early implant loss.
These assessments help in evaluating the effectiveness of the antibiotic treatment and the overall success of the implant procedure.

Who can join the trial?

6 criteria

The patient must be a medically healthy adult, classified as ASA I or II. This means they should have no or mild systemic disease.
The patient must be at least 21 years old.
The patient should 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.
The patient must not be allergic to **Amoxicillin**/**Penicillin** antibiotics, **NSAIDs** (non-steroidal anti-inflammatory drugs), or corn-starch.
The patient should have missing teeth in the back upper part of the mouth, in one or two areas, with a bone defect that needs a procedure called **sinus floor elevation**. This allows for the placement of up to 3 dental implants and a process called **guided bone regeneration** (GBR). The remaining bone height should be between 3-5 mm at each implant site.
The patient should not have any signs of problems with the sinus membrane or acute sinusitis that needs ongoing treatment.

Who cannot join the trial?

8 criteria

Patients who are allergic to **amoxicillin** or any other **antibiotics**. **Amoxicillin** is a type of medicine used to treat infections.
Patients with a history of severe allergic reactions to any medications.
Patients who are currently taking other medications that might interfere with the study treatment.
Patients with any medical condition that the study doctors believe would make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a history of drug or alcohol abuse.
Patients who are unable to follow the study procedures or attend the required visits.

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Verified
Complutense University Of Madrid
Madrid, Spain

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Investigated drugs

Amoxicillin is an antibiotic used to prevent or treat infections caused by bacteria. In this trial, it is used to reduce the risk of infections after implant surgery, which involves guided bone regeneration and sinus floor elevation. By taking this medication, patients may experience fewer complications related to bacterial infections during their recovery period.

Amoxicillin

What is already known about the treatment

Amoxicillin – Amoxicillin is administered orally, typically in the form of tablets or capsules. It is currently well-established in medical practice and literature as a commonly used antibiotic. The main therapeutic indication for amoxicillin in this trial is to prevent post-surgical complications in patients undergoing dental implant surgery with guided bone regeneration and sinus floor elevation. At the molecular level, amoxicillin works by inhibiting the synthesis of bacterial cell walls, leading to the destruction of bacteria. It is classified pharmacologically as a penicillin-type antibiotic.

Investigated diseases

Edentulism – This condition refers to the absence of teeth, specifically in the posterior maxillary quadrant of the mouth. It often occurs due to tooth loss and can lead to changes in the jawbone, such as sinus pneumatization and decreased bone height. These changes may require surgical procedures like bone augmentation and the placement of dental implants to restore function and appearance. The progression of edentulism can affect chewing, speech, and overall oral health. It may also lead to further bone loss if not addressed.