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Study on the Effectiveness of Phenoxymethylpenicillin Potassium and Amoxicillin for Patients Needing Oral Bone Augmentation

Registered 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 the use of antibiotics during dental procedures that involve building up bone in the mouth, known as oral bone augmentation. The study is examining two antibiotics: phenoxymethylpenicillin potassium, marketed as Kåvepenin, and amoxicillin, marketed as Amimox. These medications are being tested to see how effective they are in preventing infections after dental implant surgeries that require bone augmentation.

The purpose of the study is to evaluate whether a short course or a longer course of antibiotics is more effective in preventing infections after these dental procedures. Participants in the study will receive either one of the antibiotics or a placebo. The study will monitor for signs of infection, such as swelling, pain, or pus in the surgical area, and will also look at how well the bone material and dental implants survive over time.

Throughout the study, changes in the levels of bacteria in the mouth and gut will be observed, as well as any development of antibiotic resistance. The study aims to provide valuable information on the best practices for using antibiotics in dental surgeries involving bone augmentation, ultimately helping to improve patient outcomes and reduce the risk of infection.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age (18-80 years), dental condition, and referral by a dental specialist.

    Informed consent is required to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the need for oral bone augmentation, which is necessary for dental implant surgery.

    The assessment includes a review of dental and periodontal health.

  3. Step 3

    Medication administration

    Participants receive antibiotics to prevent infection during the bone augmentation procedure.

    Two types of antibiotics are used: phenoxymethylpenicillin potassium and amoxicillin, both administered orally in the form of film-coated tablets.

    The dosage for phenoxymethylpenicillin potassium is 800 mg, and for amoxicillin is 500 mg. The frequency and duration of administration are determined by the study protocol.

  4. Step 4

    Bone augmentation procedure

    The bone augmentation procedure is performed to prepare the site for dental implant placement.

    The procedure involves surgical techniques to increase the amount of bone in the jaw.

  5. Step 5

    Postoperative monitoring

    After the procedure, monitoring for signs of infection is conducted. Indicators include pus, fistula, swelling, and pain in the surgical area.

    The occurrence of these signs is evaluated to determine the effectiveness of the antibiotic treatment.

  6. Step 6

    Follow-up assessments

    Follow-up assessments are conducted to evaluate the survival of the augmented material and the dental implant.

    Changes in oral and faecal microflora, as well as antibiotic resistance, are also monitored.

  7. Step 7

    Completion of study participation

    Participation in the study is completed by the estimated end date of July 31, 2025.

    Final evaluations are conducted to assess the overall outcomes of the treatment and any long-term effects.

Who can join the trial?

5 criteria

  • Must be a male or female aged between 18 and 80 years old.
  • Must have some or all teeth missing, with gums that are either healthy or have been treated.
  • Must be referred by a general dentist or a specialist in prosthodontics (a dentist who specializes in replacing missing teeth) to a specialist clinic for oral and maxillofacial surgery (surgery of the mouth, jaw, and face) for dental implant treatment.
  • Must have an insufficient amount of bone to allow the placement of a dental implant, as determined by the surgeon performing the procedure.
  • Must have signed an informed consent form, which means you agree to participate in the study after being informed about it.

Who cannot join the trial?

3 criteria

  • Individuals who do not require **oral bone augmentation**. This is a procedure to add bone to the jaw, often needed before placing dental implants.
  • Individuals who are not within the specified age range for the study.
  • Individuals who belong to a vulnerable population, which means groups that might need special protection or care.
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Investigated drugs

Antibiotics are medications used to prevent or treat bacterial infections. In this clinical trial, antibiotics are being studied to see how effective they are when used for a short time compared to a longer time during bone augmentation procedures in dental implant surgery. The goal is to determine the best duration for antibiotic use to prevent infections and improve the success of the surgery.

What is already known about the treatment

Antibiotics – These medications are typically administered orally or intravenously, depending on the specific type and clinical need. In the context of dental procedures, they are used to prevent infections during oral bone augmentation, which is a process to increase bone volume in the jaw. Antibiotics are well-established in medical literature for their role in preventing bacterial infections. They work by targeting and inhibiting the growth of bacteria, either by killing them or stopping their reproduction. Antibiotics are classified as antimicrobial agents and are crucial in surgical settings to reduce the risk of postoperative infections.

Investigated diseases

Postoperative Infection – This condition occurs when harmful microorganisms invade the surgical site after a procedure, leading to inflammation and other symptoms. It can manifest as pus, which is a discolored fluid indicating infection, or a fistula, which is an abnormal connection between the oral cavity and implanted material. Swelling and pain in the surgical area are also common signs, although they require the presence of more definitive indicators like pus or fistula to confirm infection. The infection can complicate healing and may affect the success of procedures like bone augmentation in dental implant surgery.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517402-28-00Estimated enrolment80 patientsSponsorKarolinska Institutet

sourced from the EU Clinical Trials Register and site verification

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