Evaluation of Amoxicillin on Post-Surgical Outcomes in Patients Undergoing Implant Surgery with Guided Bone Regeneration and Sinus Floor Elevation

The primary objective of this study is to evaluate the effect of **systemic antibiotic** administration, specifically amoxicillin, compared to placebo in patients undergoing oral implant therapy with simultaneous lateral sinus floor elevation and guided bone regeneration (GBR). The focus is on assessing patient-centered outcomes, which are clinically relevant as they directly impact the patient's recovery experience and overall satisfaction with the surgical procedure. Understanding the role of antibiotics in reducing post-surgical complications can inform clinical guidelines and improve patient care in implant surgery.

The clinical trial involves participants undergoing **oral implant therapy** with simultaneous lateral sinus floor elevation and guided bone regeneration. The study population includes both male and female adults, aged 21 years and older, who are medically healthy as per ASA classification I-II. Participants are either non-smokers, previous smokers who quit at least five years ago, or light smokers consuming less than 10 cigarettes per day. The trial excludes individuals with allergies to Amoxicillin/Penicillin antibiotics, NSAIDs, or corn-starch. Participants must have edentulous spaces in the posterior maxilla requiring sinus floor elevation and allowing for the placement of up to three dental implants with simultaneous guided bone regeneration. The trial does not include individuals with signs of sinus membrane pathology or acute sinusitis requiring ongoing management. The sponsor has not provided information regarding the total number of participants in the study.

The clinical trial is designed to evaluate the effect of **systemic antibiotic** administration compared to placebo in patients undergoing oral implant therapy with simultaneous lateral sinus floor elevation and guided bone regeneration. This is a randomized, double-blind, controlled trial, categorized as a Phase IV study. The trial is expected to commence on January 1, 2023, and conclude by December 31, 2025. Participants will be randomly assigned to receive either Moxilen 500 mg hard capsules, containing **amoxicillin**, or a placebo. The trial will assess patient-centered outcomes, focusing on post-surgical complications and patient-reported outcome measures (PROMs).

The study will involve several visits, beginning with an inclusion (screening) visit to determine eligibility based on criteria such as age, smoking status, and absence of allergies to specific medications. Eligible participants will be medically healthy adults aged 21 years or older, with specific dental conditions requiring the described surgical interventions. Follow-up visits will occur at various intervals, including days 1-7 and 14 for PROMs assessment, and weeks 2, 4, 16-20, and 6 months post-crown installation for clinical recordings of post-surgical complications. The end-of-study visit will mark the conclusion of the participant's involvement in the trial.

Participant involvement is expected to last up to 6 months, with the maximum treatment period being 4 weeks. Conditions that may lead to early termination from the study include the development of adverse reactions to the study medication, non-compliance with study procedures, or withdrawal of consent by the participant. The primary endpoint will focus on PROMs, using visual analogue scores to evaluate symptoms such as bleeding, swelling, and pain. Secondary endpoints will include clinical assessments of post-surgical complications, such as flap closure, pain on palpation, and implant stability.

The clinical trial involves the administration of **Moxilen 500 mg hard capsules**, which contain the active substance **amoxicillin**. This pharmaceutical form is a hard capsule, designed for oral administration. The dosage regimen for the trial specifies a maximum daily dose of 2.5 grams, with a total maximum dose of 7 grams over the treatment period. The treatment duration is set for a maximum of 4 days. The capsules are manufactured by Medochemie Ltd. and are classified under the ATC code J01CA04, indicating their use as a systemic antibiotic. The chemical origin of the active substance ensures its efficacy in the intended therapeutic context. Participant compliance with the dosing schedule will be monitored throughout the trial to ensure adherence to the protocol.

The study also includes the use of **Amylium Maydis** as a placebo comparator. This product does not contain an active pharmaceutical ingredient and serves as a control to evaluate the effect of the experimental treatment. The pharmaceutical form and route of administration for Amylium Maydis are not specified, as it functions solely as a placebo in the trial. The inclusion of a placebo group is critical for assessing the true efficacy of the experimental treatment by providing a baseline for comparison. The trial's design ensures that any observed effects can be attributed to the active treatment rather than external factors.

Efficacy in this clinical trial will be assessed through both primary and secondary endpoints. The primary endpoint involves **Patient Reported Outcome Measures (PROMs)**, utilizing visual analogue scores (VAS) ranging from 0 to 10. These scores will evaluate wound-related symptoms such as bleeding, swelling, pain, and bruising (hematoma), as well as sinus discomfort including nosebleed, nasal congestion, rhinorrhea (excessive nasal discharge including posterior nasal drip), feeling of pressure, and hyposmia (reduction in smell). These assessments will be conducted on days 1 through 7 and on day 14 post-surgery.

The secondary endpoints will focus on clinical recordings of post-surgical complications. These will be measured at various timepoints: week 2, week 4, weeks 16 to 20, and 6 months after crown installation. Parameters to be evaluated include flap closure or dehiscence, pain or sensitivity on palpation, swelling (obliteration of the sulcus), suppuration or purulent discharge, and implant stability at initial placement and during the second stage surgery. These assessments will provide comprehensive data on the efficacy of systemic antibiotic administration compared to placebo in patients undergoing oral implant therapy with simultaneous lateral sinus floor elevation and guided bone regeneration.